The Mirena IUD causes many symptoms and complications however, in order to file a Mirena IUD lawsuit your Mirena IUD lawyer will be looking for the following:
A MIrena IUD MDL, Multi District Litigation would be helpful for women and set a tone for thousands of Mirena lawsuits to be filed in one central location under one judge. A Multi District litigation for the Mirena IUD would mean you do not need a local lawyer to file in a local court. This would be at the Federal level. There would be lead counsels assigned to the litigation and you would need to locate an experienced dangerous devices lawsuit lawyer.
If the Mirena IUD side effects warrant MDL this would be good for the thousands of women who have gotten uterine perforations from the Mirena IUD… Perforation cases are currently the ones lawyers are seriously looking at. The Mirena must have gravitated from position, become embedded in the uterus and needed to be surgically removed. There must have been no complications with the original insertion. This has to do with a concept called ” science”. A uterine perforation can be easily traced back to the Mirena. The Mirena becomes dislodged and gravitates out of position and moves. It can become embedded in the uterus or a nearby organ. The result is perforation and usually permanent infertility. These are basic facts that can be proven. Many of the other tentative symptoms cannot be traced back to the Mirena easily. They may ne very real for you but, perforations are the key complication.
Mirena MDL Overview
In January 2013, a motion for consolidation of Mirena lawsuits was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML). The motion requested the formation of a Mirena multidistrict litigation (MDL) or centralization of all Mirena lawsuits. This proposed MDL could group together lawsuits that have uterine perforations as a result of Mirena. The JPML is scheduled to hear arguments regarding the proposed MDL on March 21, 2013.
Did you suffer Injury because of Your Mirena IUD device? The Mirena IUD Helpline and Mirena IUD lawyers are here for you.The Mirena IUD Helpine Is always looking for information for our readers. We thought you would find this interesting.
Letter to Bayer from the FDA; DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration Silver Spring, MD 20993
Dear Dr. Almanakly:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a script for a live consumer-directed program (program) entitled “Mirena Simple Style Statements Program” (150-74-0002-09) for Mirena® (levonorgestrel-releasing intrauterine system) (Mirena), submitted by Bayer HealthCare Pharmaceuticals Inc. (Bayer) under cover of Form FDA-2253. The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).
According to the DESCRIPTION section of its FDA-approved product labeling (PI),1 “Mirena® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (Tbody) with a steroid reservoir (hormone elastomer core) around the vertical stem.” The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider. According to the INDICATIONS AND USAGE section of its PI, Mirena is approved for the following indication:
Mirena is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced. Mirena is recommended for women who have had at least one child.
The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.”
1 The most current version of the FDA-approved PI as of the dissemination date indicated on Form FDA-2253 was the July 21, 2008, version, and that is the version referred to in this letter. We note that the PI for Mirena was updated on October 1, 2009.
The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea. Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.
In addition to the warnings noted above, the PI details the common adverse reactions that were observed during the clinical trials for Mirena. According to the PI, “Very common adverse reactions” (>10% of clinical trial patients) included “uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea), and ovarian cysts.” Adverse reactions that were reported by 5% or more of clinical trial patients include, among others, abdominal/pelvic pain, nausea, headache, nervousness, back pain, weight increase, breast pain/tenderness, acne, decreased libido, and depressed mood.
The PI also includes precautions that patients should be counseled that Mirena does not protect against HIV infection (AIDS) or other sexually transmitted diseases, and that patients should be instructed to check that the threads attached to Mirena are still in place after each menstrual period, as there is no contraceptive protection if Mirena is displaced or expelled.
Additionally, in regards to patient follow-up following the insertion of Mirena, the DOSAGE AND ADMINISTRATION, Patient Follow-up section of the PI states (in pertinent part):
Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
Overstatement of Efficacy/Unsubstantiated Claims
Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn).2 The script of this program submitted to FDA includes an introduction from the Mom Central representative, a presentation given by Ms. Dehn regarding the use of Mirena, and a “post-party” questionnaire for the audience.
The script includes the following statements to be delivered by the Mom Central representative (emphasis added):
“This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!”
2 The Mirena program submitted to FDA also references a presentation given by a fashion stylist (Ms. Angela Hastings) that immediately follows Ms. Dehn’s presentation regarding the use of Mirena. The script of Ms. Hastings’ presentation regarding fashion tips was not submitted to FDA.
Fadwa Almanakly, Pharm.D. Page 3
Bayer HealthCare Pharmaceuticals Inc.
NDA 21-225 / MACMIS 18166
“Barb Dehn is a practicing Women’s Health Nurse Practitioner, award-winning author and nationally recognized health expert from San Francisco. Barb is going to kick things off with a discussion about romance and how to find simple ways to reconnect with our partners.”
The script also includes the following statements to be delivered by Ms. Dehn (emphasis added):
“. . . And, let’s face it, when we feel good about the way we’re put together, we feel better about approaching the romance in our lives.”
“What we’re here to talk about today – is how to find those simple ways to reconnect with ourselves and our partners.”
Following the introduction of the program, the script states that “Barb [Dehn] will begin presentation with an icebreaker – an interactive Q&A – which will touch upon issues such as busy schedules, barriers to intimacy and contraception” (emphasis added). The “icebreaker” questions include the following (in pertinent part; emphasis added):
“How many of you feel so busy that you often can’t find time to take care of yourself? And do you think this impacts your level of intimacy?”
“Do you ever feel so overwhelmed by your schedule that intimacy is much more of a “to do” on a list than a desire?”
“If you didn’t have to worry about contraception, do you think you would be more likely to be intimate with your partner?”
“Do you think if you didn’t have to worry about taking your birth control everyday, it would help you be more intimate?”
Immediately following the “icebreaker” questions, the script for Ms. Dehn states (emphasis added):
“So you mentioned that convenience and reliability are among the most important benefits of your birth control method. One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive Mirena®.”The above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes, such as those described above, must besupported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.
We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy.
The script also includes the following statements, to be presented by Ms. Dehn (emphasis added):
• “But what this party is really about is looking at the whole picture and figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.”
The above statement goes beyond the suggestion of increased intimacy to suggest that Mirena can help patients “look and feel great.” Again, FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from “looking and feeling great.” Such claims of improved patient-reported outcomes must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated instruments to measure these outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.
Omission and Minimization of Risk Information
Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The script includes the following risk presentation, to be presented by Ms. Dehn (emphasis in original):
• Only you and your healthcare professional can decide if Mirena is right for you. Mirena does not protect against HIV or STDs. Candidates for Mirena have had a child, and do not have certain cancers or acute pelvic inflammatory disease. In rare cases, perforation or embedment may occur. Mirena may become completely or partially dislodged. In the uncommon event you think you’re pregnant, contact your healthcare professional without delay. Ovarian cysts may occur and typically disappear. Changes in bleeding are common in the first few months followed by shorter, lighter periods. Periods, however, may remain irregular.
The risk presentation omits the contraindications regarding untreated lower genital tract infections and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility.We refer you to the December 17, 2008, advisory letter from DDMAC to Bayer, regarding the promotion of Mirena. This advisory letter includes a change of opinion regarding the risk presentation for Mirena. The letter states (in pertinent part, emphasis added):
Because this constitutes a change in our position, you will be provided a reasonable period of time to revise any Mirena promotional materials currently in use that omit this important risk information. Accordingly, the revisions should be completed within 90 days of receipt of this letter or at the next production of new promotional materials, whichever comes first.
The promotional program at issue here was newly developed, and as stated on the Form FDA-2253 accompanying the materials, it was disseminated on February 28, 2009, after the change of opinion letter was issued. We also refer you to your January 5, 2009, response to the change of opinion letter, stating that you intend to comply with our request.
Additionally, the script minimizes the risks associated with Mirena. Specifically, the “looking and feeling great” statement referenced above, in the context of the program as a whole, minimizes the risks associated with the use of Mirena. As stated in the Background section above, the PI for Mirena includes “very common” (experienced by >10% of clinical trial patients) adverse reactions, in addition to other serious warnings, precautions, and safety issues associated with the use of Mirena. The suggestion that Mirena will help patients “feel great” minimizes the side effects that patients may experience as a result of using the drug.
The script includes the following statements to be presented by Ms. Dehn (emphasis added):
• “. . . Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.”
The above claim that Mirena has “no . . . monthly routines” directly contradicts information contained in Mirena’s PI. According to PRECAUTIONS, Continuation and Removal section (repeated in the DOSAGE AND ADMINISTRATION, Patient Follow-up section) of the PI for Mirena, “[Patients should be] reexamine[d] and evaluate[d] . . . 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.” The PRECAUTIONS, Patient Counseling Information section of the PI also states that patients should check that the threads attached to Mirena are in place after each menstrual cycle (thus on a monthly basis), to ensure that Mirena has not become displaced or expelled, which would result in a loss of contraceptive efficacy. Therefore, the claim that there is no “monthly routine to comply with” is a false statement.
We note that the script includes instructions to check the Mirena threads monthly in a separate part of the presentation; however, this does not correct the false statement highlighted above.
Fadwa Almanakly, Pharm.D. Page 6
Bayer HealthCare Pharmaceuticals Inc.
NDA 21-225 / MACMIS 18166
Conclusion and Requested Action
For the reasons discussed above, the program is misleading in violation of the Act, 21 U.S.C. 352(n), and FDA implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).
DDMAC requests that Bayer immediately cease the dissemination of violative promotional materials for Mirena such as those described above. Please submit a written response to this letter on or before January 14, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Mirena that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266; facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS # 18166 in addition to the NDA number for Mirena. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Mirena comply with each applicable requirement of the Act and FDA implementing regulations.
The Mirena IUD Helpline receives calls daily from women with complications from the Mirena IUD. The most serious complications are perforations of the uterus, abdomen or intestines. The Mirena IUD Helpline was hoping for a consolidation of all Mirena IUD lawsuits as this makes it easier for you, the Plaintiff to file, but the manufacturer is not so happy about it.
The complications lawsuits appear to be aimed at is something called science. If the Mirena was implanted with no complications and then years later moved, gravitated or migrated and became lodged, embedded or stuck in your uterus, abdomen or intestines that is easily provable as a fault of the product based on “science”. Science appears to be an easy a equal b concept. Other complications can not as easily be equated to the IUD based on the legal concept of “science”.
Read the latest Mirena IUD News Below
Mirena IUD Helpline Keeps you Updated
Although Bayer opposes the formation of a federal MDL for the Mirena lawsuits, the drug maker did file a request to consolidate the state court Mirena litigation pending in New Jersey. However, Bayer pointed out in their recent response that the circumstances in New Jersey were unique, as all of the cases were at an early stage, with no dispositive motions pending or trial dates scheduled.
Bayer Opposes Request to Consolidate Federal Lawsuits Over Mirena IUD
Posted: 08 Feb 2013 07:30 AM PST
In response to a motion to consolidate all federal Mirena IUD lawsuits, Bayer Healthcare has filed a response opposing the centralization of the cases as part of a multi-district litigation (MDL), arguing that it would prejudice their ability to defend the safety of the implantable birth control device.
Last month, a group of plaintiffs filed a motion to establish a Mirena MDL, which would transfer all product liability lawsuits filed against Bayer over their intra-uterine contraceptive device (IUD) to one U.S. District Judge for coordinated handling during pretrial proceedings.
At that time, eight different Mirena cases filed in the federal court system were identified, with each lawsuit pending before a different judge in eight different U.S. District Courts. In addition, product liability lawyers investigating Mirena lawsuits have suggested that hundreds, if not thousands, of complaints are likely to be filed in the near future.
In a response (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 7, Bayer argued that centralization of the cases was not appropriate, and actually suggested that it would prejudice their defense by delaying the start of the first trial dates and encouraging the filing of “marginal” Mirena cases, which may require the drug maker to start negotiating Mirena settlements for business reasons, instead of legal reasons.
One of the cases identified for transfer was filed more than two years ago, and was set for trial to begin in May 2013. However, the case was stayed earlier this week pending a decision from the U.S. JPML about whether the Mirena litigation will be centralized.
Bayer argues that they would be faced with “starting over” with the MDL, which would duplicate discovery that has already been completed. The drug maker indicates that it has produced over 1.7 million pages of documents in the case and presented witnesses for depositions, suggesting that “it wants to vindicate its highly effective and currently marketed product as soon as possible.
Mirena IUD Lawsuits Involve Similar Allegations
Mirena is a T-shaped prescription intrauterine device (IUD), which is inserted into the uterus by a doctor to provide long-term birth control.
In recent weeks, a growing number of women throughout the United States have filed product liability lawsuits against Bayer alleging that they suffered severe injuries when their Mirena IUD perforated the uterus and “spontaneously” migrated following insertion.
The complaints involve common allegations that Bayer failed to adequately research the potential side effects of Mirena or warn about the risk of the IUD migrating long after it is implanted, increasing the risk of infection or serious damage to surrounding organs, often resulting in surgical removal of Mirena.
Bayer has argued that there are not sufficiently common issues of fact and law to require centralized management of the litigation, suggesting that the cases will be dominated by individual facts. The drug maker indicates that the Mirena warning label has provided information about the risk of perforation since it was introduced in 2001, so there is no need for extensive discovery about their knowledge about the risk of this complication from Mirena.
While the Mirena warning label does include information on the risk of perforation, plaintiffs argue that the language suggests that these problems only occur during insertion and that the drug maker failed to adequately warn about the risk of spontaneous migration, which may occur long after Mirena insertion. Many of the lawsuits allege that severe problems from Mirena could have been avoided if more detailed and accurate warnings had been provided.
Mirena MDL Hearing Likely in March
Consolidation of the Mirena litigation as part of an MDL, or multidistrict litigation, would result in all cases filed in U.S. District Courts throughout the country being assigned to one judge for coordinated handling in a manner similar to how a Mirena class action is managed during pretrial proceedings.
The process is designed to reduce duplicative discovery, eliminate conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts. However, while the cases are centralized, each lawsuit remains and individual claim and if a settlement or other resolution is not reached following the MDL proceedings, each case would be remanded back to the U.S. District Court where it was originally filed for a separate trial date.
The Mirena IUD Helpline receives calls daily from women nationwide about Mirena IUD Lawsuits. “I want a Mirena IUD lawyer for a Mirena IUD lawsuit” is heard daily. Many of the complications are severe but, the ones lawyers are most interested in are Uterine and organ perforations as these are based on “science”. It appears in a lawsuit “science” means it is easy to prove. If the IUD was implanted correctly with no complications and years later migrates, moves or gravitates out of position and becomes lodged or embedded in the uterus, abdomen or intestines then it is rather straight forward. There is a long tern effect of infertility. Judges and the courts appear to look at these things in a very a equal b sort of way.
However in the hope to proceed for women injured mirena IUD lawyers were hoping to consolidate. That makes it easier for you, the plaintiff of course not enjoyed by the manufacturer that harmed you.
Ultimately, the New Jersey Supreme Court declined to centralize the Mirena cases as part of an MCL, or Multi-County Litigation. Although no details were provided by the New Jersey courts, centralized management may have been turned down because most of the New Jersey lawsuits over Mirena were already pending in one county.
It is expected that the U.S. JPML will schedule oral arguments over whether to establish a federal Mirena MDL at a hearing session scheduled to occur in San Diego, California on March 21, 2013.
The Mirena IUD Helpline , Mirena IUD lawyers, are watching the progress of the Mirena IUD lawsuits. ” We believe the a multi district litigation consolidation will be announced shortly. This consolidation of lawsuits under one judge in one jurisdiction will help all women file their Mirena Injury lawsuits. As the Mirena IUD Lawsuit continues to move forward emphasis is being placed on injury where the Mirena has gravitated from the original implantation site. The device migrates and becomes embedded in the uterus or abdomen. The result is organ perforation which can lead to permanent infertility. The Mirena IUD is surgically implanted to be effective for five years.
Mirena IUD Lawsuits are being filed by women who have used the Mirena IUD and experienced an injury. The Mirena IUD Lawsuit has many similarities to other mass torts currently underway. Specidic injury related to the Mirena includes: infections, dangerous scar tissue known as an adhesion, uterine perforations, organ perforations,and infertility, abscesses, birth of a child with a birth defect, erosion of adjacent areas such as the vagina, inflammation of the membrane that lines the abdominal cavity and internal organs, intestinal perforations or obstruction, and pelvic Inflammatory Disease. There have also been some related fatalities.
Contact us today by returning the contact form or calling to discuss your specific Mirena complications with a medical social worker and get connected with a Mirena IUD lawyer.
Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market. The most serious Mirena risks and side effects include:
The Mirena IUD Helpline has observed many drug and device lawsuits for products harming women over the past years. Our T.V screens are inundated with lawyer ads targeting these injured women. The vaginal mesh is perhaps the largest multi district litigation since the Silicone Breast Implant Class Action. Other drugs have moved into settlement stages like Yaz and Fosamax. There are so many specifically targeting women. Now we have the Mirena IUD causing uterine perforation s as the IUD literally tears through the cervix or the wall of the uterus.
Uterine perforation is no joke. We speak to callers where the Mirena has moved thru the uterine wall, ripped through the cervix or entered the abdominal cavity years after the IUD was inserted with no initial complications. Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market. We expect 1000’s of lawsuits.
If you have been injured by the Mirena, we want to hear from you. Share your stories with others on our comments section. You are not alone.
Mirena IUD medical resources thru Planned Parenthood of Florida.
If you are experiencing Mirena IUD side effects you may contact these locations for help. Mirena IUF lawyers are here to help you file your Mirena IUD lawsuit.
Florida Mirena IUD lawyers are concerned about women in Florida with uterine perforations and complications from the Mirena IUD. Contact the physician the implanted the Mirena. If you need additional help you may find it here:
Boca Raton Health Center
8177 Glades Rd.
Boca Raton, FL 33434
Manatee Health Center, Bradenton
1105 53rd Avenue East, Suite 201
Bradenton, FL 34203
Fort Myers Health Center, Ft. Myers
8595 College Parkway, Suite 250
Ft. Myers, FL
Gainesville Health Center, Gainesville
914 NW 13th Street
Gainesville, FL 32601
Immokalee Center, Immokalee
419 N First Street
Immokalee, FL 34142
Jacksonville Health Center, Jacksonville
3850 Beach Blvd
Jacksonville, FL 32207
Lakeland Health Center
2250 E Edgewood Drive
Lakeland, FL 33803
Jean Shehan Health Center, Miami
3119A SW 22nd Street
Miami, FL 33145
Kendall Health Center, Miami
11440 SW 88th Street, Suite 109
Miami, FL 33176
7900 N.W. 27 Ave. #E240
Miami, FL 33147
Naples Center, Naples
1425 Creech Road
Naples, FL 34103
North Miami Health Center, North Miami
681 N.E. 125 Street
North Miami, FL 33161
Orlando – Eastside Clinic
11500 University Blvd
Orlando, FL 32817
Orlando Westside Clinic, Orlando
726 South Tampa Ave
Orlando, FL 32805
Pembroke Pines Health Center, Pembroke Pines
263 North University Drive
Pembroke Pines, FL 33024
Sarasota Health Center
736 Central Avenue
Sarasota, FL 34236
Pinellas Health Center, St. Petersburg
8950 Dr. Martin Luther King Jr. Street North, Suite 102
St. Petersburg, FL 33702
Martin County Health Center, Stuart
1322 NW Federal Hwy., Emerald Plaza
Stuart, FL 34994
The Sally Bellamy Health Center, Tallahassee
2121 W Pensacola Street
Tallahassee, FL 32304
Tampa Health Center, Tampa
8068 North 56th Street
Tampa, FL 33617
Indian River (Vero Beach) Health Center, Vero Beach
3106 20th Street
Vero Beach, FL 32960
Wellington Health Center, Wellington
10111 Forest Hill Blvd, Suite 340
Wellington, FL 33414
West Palm Beach Health Center
931 Village Blvd. Suite 904
West Palm Beach, FL 33409
Winter Haven Health Center, Winter Haven
908 Havendale Blvd
Winter Haven, FL 33881
The Mirena IUD Helpline is always looking for information we think is important to our readers. Ths article about the Mirena complications is medically oriented but, we feel it offers some valuable information.
Management of problems related to intrauterine contraception
Gillian Dean, MD, MPH
Alisa B Goldberg, MD, MPH
Mimi Zieman, MD
Vanessa A Barss, MD
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Dec 2012. | This topic last updated: Dec 5, 2012.
INTRODUCTION — Intrauterine contraception is generally well-tolerated, but side-effects and complications sometimes occur. This topic will review management of the most common problems related to intrauterine contraception with the copper T380A and the levonorgestrel-releasing intrauterine devices (IUDs) (TCu380A, ParaGard® and LNg IUD, Mirena®). General issues related to intrauterine contraception and insertion and removal of IUDs are discussed separately. (See “Overview of intrauterine contraception” and “Insertion and removal of an intrauterine contraceptive device”.)
Several terms are used to describe intrauterine contraception, including intrauterine device (IUD) and intrauterine contraceptive (IUC); the progestin-containing device is also referred to as an intrauterine system (IUS). In this topic, we use the term IUD for all types of intrauterine contraception.
EXPULSION — In the first year of use, expulsion occurs in 3 to 10 percent of women with the TCu380A and 6 percent of women with the LNg IUD [1-4]. Risk factors for expulsion include [1,5,6]:
Age less than 20 years
Insertion immediately after a second trimester abortion or postpartum
Symptoms suggesting partial or complete expulsion include cramping, vaginal discharge, intermenstrual or postcoital bleeding or spotting, male or female dyspareunia, or lengthened or absent strings. The woman may palpate all or part of the IUD in the vagina. However, some IUD expulsions are asymptomatic. Because women who experience asymptomatic IUD expulsion may not present for evaluation, it is important to teach all IUD users to check their IUD strings periodically. If complete expulsion occurs and the woman does not become pregnant, she may notice that her periods are changing back to their pre-IUD insertion pattern.
Any woman with symptoms suggestive of expulsion should be evaluated promptly. If the IUD is visible in the endocervical canal or vagina, it should be removed and should not be re-used or re-inserted.
If the IUD or its strings are not visible, complete expulsion may have occurred. The diagnosis of complete expulsion requires ultrasound confirmation that the IUD is not in the uterus, followed by x-ray documentation that the IUD is not in the abdomen or pelvis (see ‘Strings not visible’ below).
A new IUD can be inserted after expulsion if desired; standard criteria for insertion of an IUD should be met (eg, pregnancy excluded, no active infection). It is unknown whether changing the IUD type (copper or levonorgestrel) at reinsertion will reduce the risk of recurrent expulsion. (See “Insertion and removal of an intrauterine contraceptive device”.)
Recurrent expulsion — The risk of re-expulsion appears to be higher than the risk of expulsion after initial insertion, but minimal data are available. In one study, 124 women had a TCu-200B intrauterine device inserted following an expulsion: the cumulative re-expulsion rates after 6 and 12 months were 21.7 and 31.4 per 100 women .
Data on risk factors for repeat expulsion are sparse. Recurrent expulsion may be due to faulty technique or uterine factors (eg, severe flexion, abnormally shaped uterine cavity, patulous internal cervical os) [7,8].
When replacing an IUD after an expulsion, assuming the initial placement was not immediately postabortion or postdelivery, we recommend performing the placement under sonographic guidance to ensure that the IUD is placed at the uterine fundus. If a second expulsion occurs and the woman wishes to try a third IUD insertion, we recommend sonographic or hysteroscopic evaluation of the endometrial cavity to exclude anomalies or pathology that may be responsible for the expulsions (eg, adhesions, obstructing fibroids). If the cavity is abnormal, we recommend not attempting a third insertion. If the cavity is normal, a third IUD insertion can be attempted after counseling the women that she is at high risk for repeat expulsion. Furthermore, we counsel these patients that women with a history of past expulsions may be at increased risk of subsequent IUD failure even when the replaced IUD remains in situ .
MALPOSITION — The proper placement of an IUD is in the fundal portion of the uterine cavity (image 1). An IUD is malpositioned if any part of it extends into the myometrium or endocervical canal (image 1 and image 2 and image 3 and picture 1), if it is rotated, or if it is located distant from the fundus and within the lower uterine segment. Approximately 10 percent of IUDs are malpositioned , but not all malpositioned IUDs require removal (as discussed below).
A copper IUD is relatively easy to detect with ultrasound, as it gives a strong echo. The LNg IUD is more difficult to identify because only the proximal and distal ends of the vertical arms produce a detectable echo; this may or may not be enough to confirm the location of the device in the uterus. The LNg IUD produces a dark sonographic shadow, particularly on transvaginal ultrasound, that can also aid in its localization .
If ultrasound performed for any reason reveals that the IUD is malpositioned, the patient should be asked whether she is experiencing any symptoms of a displaced IUD, such as new or especially bothersome cramping, heavy menstrual bleeding, or intermenstrual bleeding or spotting [10,12]. If the woman is symptomatic, the IUD should be removed and, ideally, a new IUD is placed at the same visit to avoid a gap in contraception. We often perform replacements under ultrasound guidance to be sure of proper fundal positioning.
There are limited data to guide the management of an incidental finding of a displaced IUD in a woman who is asymptomatic. Theoretically, a small change in position should not affect the contraceptive effects of the progestin or copper that is released. Data from a randomized trial of the levonorgestrel-releasing IUD support this hypothesis, showing no difference in pregnancy rates between intracervically and fundally placed devices . There are no similar studies of copper IUDs. Pregnancy appears to be more common in women with malpositioned copper IUDs than correctly positioned copper IUDs, but it is unknown whether the malpositioned IUD is the cause or the result of pregnancy [14,15]. The extent of malposition (eg, low intrauterine displacement versus arms embedded in myometrium) is also a probable factor affecting the risk of contraceptive failure. In a series of 28 women with malpositioned IUDs left in situ and followed for two years, there were no unintended pregnancies . In contrast, women who had malpositioned devices removed or expelled often did not initiate another highly effective method of contraception and became pregnant.
As a general rule, if a LNG or Copper T380 IUD is located in the lower uterine segment or near (but not at) the fundus, we tend to leave it in place as most of these IUDs will not be expelled, and some migrate to a more fundal position [16-18]. If an IUD is below the internal cervical os, we recommend removal because expulsion may follow, and may not be detected. Ideally, a new IUD will be placed or another highly effective contraceptive method (eg, implant) will be initiated at the same visit in order to avoid an interruption in contraception.
In a case series of 18 women in whom a LNg-releasing IUD was displaced towards the cervical canal on sonographic examination, the IUD was easily repositioned toward the fundus using an alligator forceps in 17 patients; however, in 3 of these patients, it became malpositioned again within two months . At present, we do not attempt to reposition malpositioned IUDs; instead, we follow the management plans described above. However, if the success of repositioning IUDs is confirmed in other studies, it may prove to be an effective method of managing a symptomatic malpositioned IUD.
Malposition may be more likely when placement is difficult, such as in women with a distorted uterine cavity, adenomyosis or obesity. In these cases, placement by an experienced clinician and use of ultrasound guidance may reduce the risk of malposition.
STRINGS NOT VISIBLE — If the IUD strings are not visible on speculum examination, possible explanations from most to least common are:
The IUD is in situ, but the strings are curled and retracted into the endocervical canal or uterine cavity, or they are broken. Uterine enlargement secondary to fibroids or pregnancy, or rotation of the IUD can also cause retraction of strings;
The IUD has been expelled;
The IUD has perforated the uterus and is in the myometrium or abdomen.
The first step is to exclude pregnancy. If the woman is pregnant, an ultrasound should be performed to determine the location of the IUD and the pregnancy. Management depends upon the location of the IUD, the trimester of pregnancy, and the patient’s desire to continue or terminate the pregnancy (see ‘Pregnancy’ below).
If the woman is not pregnant, we twist a cytobrush in the endocervical canal to try to draw the string out of the canal. If the string becomes visible with this maneuver, no additional action is required.
If this maneuver is unsuccessful, we examine the endocervical canal with a uterine sound or an endocervical speculum to determine if the IUD is in the process of being expelled. Usually the strings become more visible in this situation, but they can also become twisted and remain hidden from view. If the IUD is in the cervix, we remove it using a grasping forceps (eg, Bozeman uterine packing forceps or alligator forceps), IUD hook, IUD thread retriever, or Kelly clamp, and, if the woman desires, we replace it with a new IUD. Prophylactic antibiotics are unnecessary when removing the IUD from the uterus or cervix.
If these maneuvers do not locate the strings, we obtain an ultrasound examination to localize the IUD . Interim contraception should be provided if ultrasonography is scheduled for a later date. If ultrasound examination shows that the IUD is in the proper position within the uterine cavity, the woman may continue to use it for contraception (despite the strings not being accessible). We suggest performing an ultrasound annually for the first several years to ensure that the IUD has remained in place . After several years, the risk of expulsion is so low that the use of confirmatory ultrasound may be discontinued; the patient should be instructed to return if she develops symptoms suggestive of IUD expulsion or displacement.
If she wishes to discontinue the IUD, an alligator forceps, Bozeman uterine packing forceps, or an IUD hook can be used to grasp and remove it. Ultrasound guidance can be helpful if blind attempts to grasp the IUD are unsuccessful. Analgesia, if needed, can be provided by infusing a local anesthetic (eg, 5 mL of 2 percent lidocaine) into the uterine cavity with an angiocatheter  or by paracervical block, either alone or in combination with conscious sedation . The cervix can be softened, if needed, with misoprostol in order to facilitate the procedure . The IUD can also be removed using suction: attach a small cannula to a manual uterine aspirator (eg, IPAS syringe) or an electric vacuum aspirator. Hysteroscopic removal is rarely necessary, but is the next step if other methods have been unsuccessful. (See “Pudendal and paracervical block” and “Procedural sedation in adults”.)
If ultrasound examination does not locate the IUD, we obtain anteroposterior and lateral upright plain radiographs of the entire abdomen and pelvis . Both the TCu380A and the LNg IUD are radiopaque; therefore, if the IUD is not visualized on x-ray examination, expulsion has occurred. Expulsion cannot be diagnosed without x-ray documentation unless the expulsion was noted by the user. It is usually impossible to detect an IUD that is located outside the uterus with ultrasound. A new IUD can be inserted, if desired.
If x-ray shows that the IUD is located outside the uterine cavity, a perforation has occurred.
PERFORATION — Uterine perforation occurs during IUD insertion and complicates about 1 in 1000 insertion procedures . Risk factors include clinician inexperience in IUD placement, an immobile uterus, a retroverted uterus, and the presence of a myometrial defect (pre-existing or created during the procedure by the uterine sound or the IUD inserter). (See “Insertion and removal of an intrauterine contraceptive device”.)
Since perforation may not be recognized immediately, many clinicians re-examine the patient six weeks after IUD insertion to look for signs and symptoms of perforation, such as shortening of string length. Perforations diagnosed after the insertion procedure have been attributed to spontaneous IUD migration; although difficult to disprove, we think this explanation is implausible.
Ultrasound is used to determine the location of a perforated IUD (x-ray can be used if ultrasound is not available). As discussed above, if ultrasound examination does not reveal the location of the IUD, the IUD may have been expelled. An x-ray of the pelvis and abdomen should be obtained since expulsion cannot be diagnosed reliably without x-ray documentation.
Once perforation has been identified, experts recommend treating the woman with antibiotics as for pelvic inflammatory disease . (See “Treatment of pelvic inflammatory disease”.) Although serious complications following perforation are uncommon, most experts, but not all, recommend that any perforated IUD be removed unless the surgical risk is excessive [25-28]. The major concerns of nonintervention are adhesion formation and their sequelae, and perforation into bowel, bladder, or blood vessels .
If the IUD is in the abdomen or perforating through the myometrium, operative laparoscopy is the preferred method of removal and can be performed electively in asymptomatic patients, and is usually successful . If laparoscopy is unsuccessful due to extensive adhesions, the procedure should be converted to a laparotomy [31,32].
If the IUD is embedded in the myometrium, operative hysteroscopy may be required for removal . An IUD that has migrated completely through the myometrium may be anywhere in the pelvis. Most frequently, it is found encased in adhesions, adherent to the sigmoid colon or omentum, or freely floating in the posterior cul de sac (pouch of Douglas) [28,32,34-38]. There are case reports of IUD perforation into the bladder; intravesical location of an IUD may cause urinary tract symptoms. Perforation into the rectum has also been reported, but modern IUDs, including the LNg IUD and various forms of the TCu380A, have not been associated with intestinal injury. IUDs embedded in the omentum can be hard to find because radiographically they appear to be located in the pelvis, but when the patient is placed into Trendelenburg position for laparoscopy, the omentum and IUD can shift into the upper abdomen . An intraoperative x-ray can help localize the IUD.
Patients whose IUDs have perforated and been recovered may be offered another IUD, but we recommend placing future IUDs in such patients under ultrasound guidance.
IUD perforation is not a contraindication to future labor and vaginal delivery, as the uterine defect is small. A literature review did not identify any case reports of rupture of a pregnant uterus associated with prior IUD perforation.
Uterine perforation during insertion is discussed in detail separately. (See “Uterine perforation during gynecologic procedures”.)
PARTNER FEELS STRINGS — IUD strings should be trimmed to approximately 3 to 4 cm from the external os. If the strings are cut too short, the partner may experience irritation during intercourse. If this occurs, we suggest trimming the strings flush with the cervix, or replacing the IUD and leaving longer strings. Some women do not want their partners to know that they are using contraception for fear of violence or birth control sabotage. The IUD may be used in these patients by trimming the string flush with the cervix so that it cannot be detected.
PAIN — If a woman with a longstanding IUD develops new severe cramping or abdominal tenderness, she should be evaluated for pelvic inflammatory disease, ectopic pregnancy, threatened or incomplete miscarriage, and IUD expulsion or perforation.
Dysmenorrhea is often worse in the first few cycles after insertion of a copper IUD, and along with unscheduled bleeding, is one of the primary reasons for copper IUD discontinuation. However, discontinuation rates for pain are low (0.1 to 2.4 percent) in both copper and LNg IUD users [1,40-44]. Mild to moderate dysmenorrhea can be treated with nonsteroidal antiinflammatory drugs (NSAIDs) begun at the onset of menses and maintained for the first three days of each menstrual cycle (table 1). Women with severe dysmenorrhea and a copper IUD should consider the LNg IUD or choose another method of contraception.
ABNORMAL BLEEDING — The TCu380A and the LNg IUD are associated with changes in uterine bleeding patterns, which may include intermenstrual bleeding (both IUDs), increased volume of menstrual bleeding (primarily TCu380A), prolonged menstrual bleeding (primarily LNg IUD), or amenorrhea (primarily LNg IUD). Counseling women about the expected changes in bleeding patterns prior to insertion may enhance adherence to the method. Unexpected changes in bleeding patterns or changes that are not tolerable to the patient should be evaluated.
Possible causes of new onset abnormal bleeding after prolonged use of IUDs include displacement of the device, pregnancy (intrauterine or ectopic), and infection, as well as gynecologic disorders of the cervix or uterus (eg, leiomyomas, polyps, endometrial cancer) [24,45]. (See “Management of unscheduled bleeding in women using contraception”, section on ‘Intrauterine contraception (IUD)’.) .
Women over age 40 or with risk factors for endometrial cancer who develop new abnormal bleeding should undergo evaluation of the endometrium [24,47]. It is important to first exclude IUD displacement, infection, and pregnancy as possible causes of the abnormal bleeding. Although some clinicians remove the IUD before sampling the uterus, an endometrial biopsy using a Pipelle can be performed with the IUD in place. If an adequate tissue sample cannot be obtained, the IUD should be removed before resampling. We do not send the IUD for culture since colonization without infection is common .
Chronic endometritis is a common finding in endometrial biopsies of women who have used an IUD for more than five years . We do not treat this histological diagnosis unless the patient also has pain. (See “Endometritis unrelated to pregnancy”, section on ‘Intrauterine foreign objects, intrauterine growths, and radiation therapy’.)
TCu380a IUD — The copper IUD is associated with increased menstrual flow both in length of menses and in amount of blood loss. A prospective study of over 1900 Copper T380A users found that many side effects related to bleeding and pain decreased over time . However, most of the improvement was in symptoms occurring during menses, whereas most intermenstrual complaints (such as unscheduled bleeding) did not decrease with time.
We remove the IUD if the woman complains of menorrhagia and experiences a clinically significant fall in hemoglobin. These patients may consider another method of contraception or insertion of a LNg IUD since the mean per cycle blood loss for the LNg IUD is 5 mL versus 55 mL for the copper IUD [4,49].
LNg IUD — The LNg IUD is associated with a reduction in menstrual blood loss; LNg IUD users report fewer bleeding or spotting days per month compared with noncontraceptors and users of copper IUDs . However, many LNg IUD users experience episodes of unscheduled bleeding, which may be limited to spotting. The incidence of unpredictable bleeding is greatest in the initial six months of use, although episodes may occur throughout usage.
The proportion of users with amenorrhea increases with duration of use . At six months of use, 44 percent of users have amenorrhea, 25 percent experience oligomenorrhea, and 25 percent experience unscheduled spotting; the remainder have either normal or heavy bleeding. At 24 months of use, 50 percent have amenorrhea, 25 percent have oligomenorrhea, and 11 percent have spotting; again the remainder report either normal or heavy bleeding . Amenorrhea in LNg IUD users is due to endometrial decidualization and atrophy; at one year, the majority of women have ovulatory cycles [41,50,52]. The decrease in uterine bleeding that occurs in most LNg IUD users is associated with a corresponding increase in hemoglobin levels [3,41].
Changes in bleeding patterns, primarily unscheduled spotting and bleeding and prolonged bleeding episodes, are the main reasons for premature LNg IUD removal. Some early studies reported amenorrhea was the principal cause for removal, but subsequent studies found that amenorrhea was associated with continuation; this change may reflect improved counseling about expected changes in bleeding patterns [41,53,54]. Complaints of menstrual problems, including amenorrhea and spotting, decline with use beyond one year and with patient age greater than 30 years [41,54]. Options for treatment are discussed separately. (See “Management of unscheduled bleeding in women using contraception”, section on ‘Intrauterine contraception (IUD)’.)
Any LNg IUD user presenting with new onset of amenorrhea should have a pregnancy test; once pregnancy is excluded, further pregnancy tests are not required.
VAGINAL DISCHARGE — Some women report increased vaginal discharge with the IUD; this is usually normal leukorrhea and not a sign of infection .
Pelvic inflammatory disease — Pelvic inflammatory disease (PID) is most strongly associated with the insertion process and with the user’s risk of acquiring a sexually transmitted disease (STD) [55,56]. The risk of infection is greatest in the first 20 days after insertion (range 1 to 10 per 1000 women undergoing insertion [55,57]) and is rare thereafter (1.4 per 1000 women undergoing insertion ), and does not increase with prolonged IUD use. PID following insertion is due to a polymicrobial infection, usually involving anaerobic bacteria from the cervix and vagina . Risk factors include bacterial vaginosis, cervicitis, and contamination of the endometrial cavity at insertion [24,33].
Infections more than one month after insertion are generally due to a newly acquired STD [33,58]. The LNg IUD is probably protective against PID from newly acquired STDs because progestin thickens cervical mucus, making it less permeable to sperm and bacteria . Although the copper IUD does not offer this same protection, it does not appear to increase the risk of PID or of serious infection .
If a woman has clinical signs and symptoms of PID, standard antibiotic treatment should be initiated. The World Health Organization (WHO) has stated that the IUD does not have to be removed if the provider feels the advantages of continuing the method outweigh the risks [61,62]. However, this recommendation was based upon data from three retrospective series [63-65]. The only randomized trial (published after the WHO statement ) showed that removing the IUD before initiating medical therapy increased the rate of clinical improvement of mild to moderate PID compared with patients in whom the IUD was left in situ during treatment . Therefore, in settings where a replacement IUD is readily available, we recommend administering appropriate antibiotics followed immediately by removal of the IUD, as well as use of an alternative method of contraception [66,67]. Antibiotics should be administered before IUD removal because bacteremia may occur with removal of an IUD in the setting of PID . We send the IUD for culture, as microbiology results can be helpful if the patient does not respond to empiric therapy.
If the woman wants the IUD replaced, a new IUD may be inserted three months after the infection has resolved if she is no longer at elevated risk of PID. Because infection is associated with insertion, clinicians should avoid premature replacement of IUDs unless replacement is clinically indicated and a good alternative is unavailable [55,56]. In resource poor settings where a replacement IUD is not available, it may be preferable to treat mild to moderate PID without removal of the IUD. (See “Treatment of pelvic inflammatory disease”.)
Asymptomatic women who have laboratory evidence of gonorrhea or chlamydia should receive standard treatment. Although IUD removal is not necessary, the patient’s appropriateness for continued use of an IUD should be reassessed . (See “Genital Chlamydia trachomatis infections in women” and “Treatment of uncomplicated gonococcal infections”.)
Vaginitis — Women with bacterial vaginosis, trichomonas vaginalis, or candidiasis should receive standard treatment without IUD removal. Whether women with IUDs are at higher risk of developing bacterial vaginosis is controversial [68,69]. (See “Bacterial vaginosis” and “Trichomonas vaginalis” and “Candida vulvovaginitis”.)
Actinomyces on cervical cytology — Actinomyces, a Gram positive anaerobic bacillus, is part of the normal flora of the gastrointestinal tract and is commonly present in normal vaginal flora . Although there are several case reports of endometritis, pelvic inflammatory disease, pelvic abscess, and retroperitoneal fibrosis associated with actinomyces in IUD users [71,72], the identification of actinomyces in the vagina or cervix by any laboratory technique is not diagnostic of disease and is not predictive of development of disease .
Approximately 7 percent of women using an IUD have actinomyces-like organisms on a Papanicolaou (Pap) test ; only about half of these women will have positive actinomyces cultures [73,74]. If the cervical cytology report indicates actinomyces-like organisms, then we suggest that the woman be notified of the finding and examined. If she is asymptomatic, the cytology finding probably represents colonization. There is no evidence to support antibiotic treatment or IUD removal in asymptomatic women [33,74]. The woman should be informed that she should contact her health care provider if she develops signs of pelvic inflammatory disease. (See “Clinical features and diagnosis of pelvic inflammatory disease”.)
On the other hand, if the woman shows signs or symptoms of pelvic infection (pelvic mass or pain, uterine tenderness), antibiotics should be administered followed by removal of the IUD, which is sent for anaerobic culture . Removal of the IUD is important because actinomyces preferentially grow on foreign bodies. The diagnosis can be difficult to make and therapy is individualized, depending on the initial burden of disease and the clinical and radiological responses to antibiotics. Actinomyces is sensitive to penicillin; tetracyclines are used for penicillin allergic patients. Although some experts advocate oral therapy for very early pelvic actinomyces , accurate diagnosis of early stages of infection is difficult given the nonspecific clinical features of even advanced disease. Therefore, actinomyces infection is generally treated with intravenous antibiotics. Prolonged intravenous therapy (weeks to months) is indicated for confirmed actinomyces-related tuboovarian abscess or disseminated infection ; surgery may also be necessary. Infectious disease consultation is important for these cases. We counsel women with a history of actinomyces abscesses against future IUD use. (See “Abdominal actinomycosis”, section on ‘Diagnosis’ and “Abdominal actinomycosis”, section on ‘Management’.)
Of note, in one review, only 50 percent of women with pelvic actinomyces abscesses had actinomyces organisms identified on a prior Papanicolaou smear .
The LNg IUD seems to have a lower incidence of actinomyces-like organisms noted on Pap smear than copper IUDs .
Toxic shock syndrome — Rare cases of staphylococcal and streptococcal toxic shock syndrome attributed to IUD use have been reported [78-80]. (See “Epidemiology, clinical manifestations, and diagnosis of streptococcal toxic shock syndrome” and “Staphylococcal toxic shock syndrome” and “Treatment of streptococcal toxic shock syndrome”.)
EXPIRED AND DIFFICULT TO REMOVE IUDs — Women sometimes present with an IUD that has been retained beyond its ‘expiration’ date. If the string is visible, the IUD should be removed.
If the string is not visible, the location should be determined by ultrasound. If the IUD is confirmed to be intrauterine, we suggest removal in the office or an appropriately equipped ambulatory procedure room using an alligator forceps, Bozeman uterine packing forceps, or IUD hook. Difficult removals should be performed under ultrasound guidance or using a hysteroscope with a grasper . Sometimes conscious sedation is required.
If removal is unsuccessful and the woman is asymptomatic, premenopausal, and does not currently require contraception, one option is to leave the IUD in place, but there are no data about the safety of this approach. If she develops symptoms (pain, abnormal bleeding), the IUD should be removed, which may require anesthesia and operative hysteroscopy, particularly if the IUD is embedded in the myometrium. The risks and benefits of anesthesia and an operative procedure need to be weighed against those of leaving the IUD in place indefinitely (eg, rare case reports of pelvic actinomycosis [82,83]). These decisions are patient-specific and need to be made on a case by case basis.
If the woman requires contraception, removal and replacement depend on the type of IUD. Studies of long-term use of the copper T380A IUD show high contraceptive efficacy and safety for up to 20 years of use, although data for use beyond 15 years are limited . For the LNg IUD (Mirena®), efficacy may decrease after five years and is only proven through seven years . Older inert IUDs can be left in place indefinitely, but generally are removed and replaced with newer medicated IUDs due to the lower efficacy of the inert devices. In general, we would remove any IUD when the woman reaches menopause (ie, amenorrhea for one year). (See “Overview of intrauterine contraception”, section on ‘Menopausal women’.)
PREGNANCY — The risk of pregnancy is highest in the first year after IUD insertion . Malposition of the IUD is a risk factor (picture 1) .
Women who conceive with an IUD in place have a greater risk of adverse pregnancy outcomes compared with the general obstetrical population. Risks include miscarriage, preterm delivery, chorioamnionitis and septic abortion. Among women who conceive with an IUD in situ, the miscarriage rate is 40 to 50 percent, a rate more than two-fold higher than that of women who become pregnant without an IUD .
The risk of adverse events is highest when the IUD is left in place, although women who have the IUD removed still have an increased risk of adverse events throughout pregnancy, including preterm delivery . There does not appear to be an increased risk of birth defects in pregnancies conceived and carried with an IUD in situ, although there are insufficient data to draw definitive conclusions about the effect of levonorgestrel exposure on the fetus [87,88].
If a woman becomes pregnant with an IUD in place, we first determine whether the pregnancy is intrauterine or extrauterine. (See “Clinical manifestations, diagnosis, and management of ectopic pregnancy”.) We suggest the following steps in the evaluation and management of intrauterine pregnancy in a patient with an IUD in situ:
First trimester intrauterine pregnancy — If the IUD strings are visible on speculum examination, remove the IUD to decrease the risk of subsequent miscarriage and infection . Antibiotics are unnecessary.
If the strings are not visible and the patient wishes to continue the pregnancy, we suggest removing the IUD under ultrasound guidance using an alligator forceps or a Bozeman uterine packing forceps [89,90]. Removal can also be attempted by hysteroscopy. Data on hysteroscopic removal of IUDs in early pregnancy are limited; therefore, it is not clear whether this technique poses greater or lesser risk of pregnancy loss than instrument removal under ultrasound guidance [91,92]. We recommend antibiotic prophylaxis when instrument removals are performed during pregnancy, including when IUD removal is to be followed by pregnancy termination (see below). If the IUD cannot be removed by pulling the strings or removed easily using either instruments under sonographic guidance or hysteroscopy, the IUD may be left in situ. The risks of pregnancy loss with aggressive attempts at IUD removal must be weighed against the risks of adverse maternal and fetal outcomes later in pregnancy, including infection and preterm delivery, if the IUD is left in place.
If the woman desires pregnancy termination, IUD removal can be performed at the time of the termination. Manual or electric vacuum aspiration or an instrument such as an IUD hook, Bozeman uterine packing forceps, alligator forceps, ring forceps, or ovum forceps can be used to remove the IUD. However, if strings are visible upon initial diagnosis and there may be a significant delay until pregnancy termination can be performed, we recommend pulling the strings to remove the IUD as soon as possible, since the strings may no longer be visible as the uterus grows and removal may be more difficult later in gestation.
In the setting of miscarriage with IUD in place, we suggest removing the IUD and prescribing antibiotics (eg, doxycycline 100 mg twice a day or ampicillin 500 mg four times a day for seven days).
Second trimester pregnancy — We counsel these women that if the IUD remains in situ, there is an increased risk of preterm labor and delivery (fourfold increase), second trimester fetal loss, and infection, but no proven increase in risk of birth defects [4,33,45,93]. In addition, in a LNg IUD user, there are theoretical fetal risks associated with intrauterine hormone exposure . Removal of the IUD may cause rupture of membranes, bleeding, pregnancy loss, or fetal trauma ; however, if the IUD is removed or expelled without complications, there is no increased risk of miscarriage [4,33,95].
Given this information, for pregnancies after 12 weeks, we suggest removing the IUD by pulling on the strings if the strings are visible and removal is unlikely to disrupt the placenta or membranes (based upon ultrasound localization of the IUD and placenta) [45,90,95-97].
If the strings are not visible in the early second trimester, the IUD may be removed under ultrasound guidance if removal appears feasible, the IUD is not located behind the placenta, and it does not appear to be incorporated into the gestational sac. In particular, we recommend ultrasound guided removal in these cases if the IUD is in the lower uterine segment . If the IUD appears embedded in the placenta, located behind the placenta, or protrudes into the gestational sac, we suggest leaving the IUD in situ.
In the late second trimester, if the strings are not visible, the IUD should be left in place. The patient should be counseled that her risks of miscarriage and premature delivery are increased relative to women whose IUDs may be easily removed .
HORMONAL SIDE EFFECTS OF LNg-IUD — Hormonal side effects (including hirsutism, acne, weight change, nausea, headache, mood changes, and breast tenderness) are the most common reasons for elective LNg IUD removal in the first 36 months of use . LNg IUD users also have more discontinuations because of hair and skin changes and headache than users of copper IUDs [41,59,98]. These complaints may be due to the systemic effects of levonorgestrel, even though plasma levonorgestrel levels are low . In the first five years of use, approximately 12 percent of women prematurely discontinue the LNg IUD because of hormone-attributable complaints [41,54,99].
ABNORMAL CERVICAL CYTOLOGY — Women with IUDs are not at increased risk of cervical intraepithelial neoplasia (CIN); they should undergo routine assessment in accordance with American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines on cervical cancer screening. Benign cervical changes, such as cervical inflammation and metaplasia, are more common in IUD users than non-users [41,100-102], but cervical cancer is less common in IUD users. (See “Overview of intrauterine contraception”, section on ‘Cancer risk reduction’.)
If an ablative or excisional procedure is required for management of CIN, it may be performed with the IUD in situ. For loop electrosurgical excision procedures (LEEP), some clinicians perform the LEEP in two segments, holding the strings anteriorly while removing the posterior segment of the biopsy and then holding the strings posteriorly for removal of the anterior segment. This approach requires more skill than the usual LEEP and increases the chance that a suboptimal specimen will be obtained. Another cumbersome technique involves tying a suture to the strings and bringing the lengthened strings through a hollow plastic tube, which is placed in the endocervical canal to protect the enclosed strings during the LEEP .
We recommend the following approach for LEEP or ablative procedures with an IUD in situ: push the strings into the cervical canal using a cytobrush and then perform the procedure in the usual fashion. After completing the procedure, tease the strings back out using a cytobrush. If the strings become damaged during the procedure, the IUD may be managed as in a patient with retracted strings (see ‘Strings not visible’ above). However, some providers find this approach more difficult than the two segment approach.
We do not recommend prophylactic antibiotics for these procedures.
INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, “The Basics” and “Beyond the Basics.” The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.
Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on “patient info” and the keyword(s) of interest.)
Beyond the Basics topics (see “Patient information: Long-term methods of birth control (Beyond the Basics)”)
SUMMARY AND RECOMMENDATIONS
If the intrauterine device (IUD) strings are not visible on speculum examination, possible explanations are:
The IUD is in situ, but the strings are retracted into the endocervical canal or uterine cavity. The strings may be teased into the correct position. (See ‘Strings not visible’ above.)
The IUD has been expelled. This requires supportive ultrasound and x-ray documentation. (See ‘Expulsion’ above.)
The IUD has perforated the uterus and is in the myometrium or abdomen. We suggest surgical removal rather than expectant management (Grade 2C). (See ‘Perforation’ above.)
The patient is pregnant. The IUD may be in situ, but the pregnant uterus has drawn the strings up into the uterine cavity so they are no longer visible. Alternatively, the device may have been expelled or perforated, and thus not protected the women against pregnancy. (See ‘Pregnancy’ above.)
Malpositioned (greater than 20 mm from the fundus in a normal uterus) IUDs in symptomatic women should be removed. In asymptomatic women who wish to continue IUD use, the IUD may be left in place if it is located above the internal os and if the woman would not replace it or choose another highly effective method of contraception. We suggest removal of malpositioned IUDs located below the level of the internal os. (See ‘Malposition’ above.)
In women with a history of expulsion, perforation, or malposition of a past IUD, the next IUD should be placed under sonographic guidance. (See ‘Recurrent expulsion’ above.)
If a woman with a longstanding IUD develops new severe cramping or abdominal tenderness, she should be evaluated for pelvic inflammatory disease, ectopic pregnancy, miscarriage, and IUD expulsion or perforation. (See ‘Pain’ above.)
Mild and moderate dysmenorrhea can often be controlled with nonsteroidal antiinflammatory drugs. (See ‘Pain’ above.)
Possible causes of new onset abnormal bleeding in women after prolonged use of IUDs include displacement of the device, pregnancy (intrauterine or ectopic), infection, as well as gynecologic disorders of the cervix or uterus (eg, leiomyomas, polyps, endometrial cancer). In women over age 40 or with risk factors for endometrial cancer who develop abnormal bleeding, the endometrium should be evaluated. Any LNg IUD user presenting with new onset of amenorrhea should have a pregnancy test. (See ‘Abnormal bleeding’ above.)
For women who develop symptomatic pelvic inflammatory disease, we suggest administration of appropriate antibiotics followed by removal of the IUD rather than treatment with the IUD in situ (Grade 2B). An alternative method of contraception should be prescribed. (See ‘Pelvic inflammatory disease’ above.)
Standard antibiotic treatment without IUD removal may be offered to asymptomatic women with laboratory evidence of gonorrhea or chlamydia. The patient should be assessed for appropriateness for continued IUD use. (See ‘Infection’ above.)
The identification of actinomyces in the vagina or cervix by any laboratory technique is not diagnostic of disease and is not predictive of development of disease. We suggest avoiding treatment of actinomyces in asymptomatic women (Grade 2C). (See ‘Actinomyces on cervical cytology’ above.)
Among women who conceive with an IUD that remains in situ, the risk of miscarriage is 40 to 50 percent, a rate twice as high as that of the general obstetric population. Whenever possible, we suggest removing the IUD (Grade 2C). (See ‘Pregnancy’ above.)
If loop electrosurgical excision procedure (LEEP) or an ablative procedure is to be performed with IUD in situ, we suggest leaving the IUD in situ and either pushing the strings into the cervical canal to get them out of the way or performing a LEEP in two segments. (See ‘Abnormal cervical cytology’ above.)
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Rivera R, Chen-Mok M, McMullen S. Analysis of client characteristics that may affect early discontinuation of the TCu-380A IUD. Contraception 1999; 60:155.
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Anteby E, Revel A, Ben-Chetrit A, et al. Intrauterine device failure: relation to its location within the uterine cavity. Obstet Gynecol 1993; 81:112.
Petta CA, Faúndes D, Pimentel E, et al. The use of vaginal ultrasound to identify copper T IUDs at high risk of expulsion. Contraception 1996; 54:287.
Morales-Rosello J. Spontaneous upward movement of lowly placed T-shaped IUDs. Contraception 2005; 72:430.
Faundes D, Perdigao A, Faundes A, et al. T-shaped IUDs accomodate to their position during the first three months after insertion. Contraception 2000; 62:165.
Ber A, Seidman DS. Management of the malpositioned levonorgestrel-releasing intrauterine system. Contraception 2012; 85:369.
Peri N, Graham D, Levine D. Imaging of intrauterine contraceptive devices. J Ultrasound Med 2007; 26:1389.
Marchi NM, Castro S, Hidalgo MM, et al. Management of missing strings in users of intrauterine contraceptives. Contraception 2012; 86:354.
Güney M, Oral B, Mungan T. Efficacy of intrauterine lidocaine for removal of a “lost” intrauterine device: a randomized, controlled trial. Obstet Gynecol 2006; 108:119.
Prabhakaran S, Chuang A. In-office retrieval of intrauterine contraceptive devices with missing strings. Contraception 2011; 83:102.
Hatcher, RA, Trussell, J, Stewart, F, et al. Contraceptive Technology, 19th ed, Ardent Media, Inc., New York 2007.
Chen CP, Hsu TC, Wang W. Ileal penetration by a Multiload-Cu 375 intrauterine contraceptive device. A case report with review of the literature. Contraception 1998; 58:295.
Adoni A, Ben Chetrit A. The management of intrauterine devices following uterine perforation. Contraception 1991; 43:77.
Zakin D, Stern WZ, Rosenblatt R. Complete and partial uterine perforation and embedding following insertion of intrauterine devices. II. Diagnostic methods, prevention, and management. Obstet Gynecol Surv 1981; 36:401.
Markovitch O, Klein Z, Gidoni Y, et al. Extrauterine mislocated IUD: is surgical removal mandatory? Contraception 2002; 66:105.
Vasquez P, Schreiber CA. The missing IUD. Contraception 2010; 82:126.
Gill RS, Mok D, Hudson M, et al. Laparoscopic removal of an intra-abdominal intrauterine device: case and systematic review. Contraception 2012; 85:15.
Andersson K, Ryde-Blomqvist E, Lindell K, et al. Perforations with intrauterine devices. Report from a Swedish survey. Contraception 1998; 57:251.
Ozgun MT, Batukan C, Serin IS, et al. Surgical management of intra-abdominal mislocated intrauterine devices. Contraception 2007; 75:96.
Speroff, L, Darney, P. A Clinical Guide for Contraception, 3rd ed, Lippincott Williams & Wilkins, Philadelphia 2001.
Dietrick DD, Issa MM, Kabalin JN, Bassett JB. Intravesical migration of intrauterine device. J Urol 1992; 147:132.
El-Hefnawy AS, El-Nahas AR, Osman Y, Bazeed MA. Urinary complications of migrated intrauterine contraceptive device. Int Urogynecol J Pelvic Floor Dysfunct 2008; 19:241.
Singh I. Intravesical Cu-T emigration: an atypical and infrequent cause of vesical calculus. Int Urol Nephrol 2007; 39:457.
Khan ZA, Khan SA, Williams A, Mobb GE. Intravesical migration of levonorgestrel-releasing intrauterine system (LNG-IUS) with calculus formation. Eur J Contracept Reprod Health Care 2006; 11:243.
Heinberg EM, McCoy TW, Pasic R. The perforated intrauterine device: endoscopic retrieval. JSLS 2008; 12:97.
Nitke S, Rabinerson D, Dekel A, et al. Lost levonorgestrel IUD: diagnosis and therapy. Contraception 2004; 69:289.
Hubacher D, Chen PL, Park S. Side effects from the copper IUD: do they decrease over time? Contraception 2009; 79:356.
Sivin I, Stern J. Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR). Fertil Steril 1994; 61:70.
Baveja R, Bichille LK, Coyaji KJ, et al. Randomized clinical trial with intrauterine devices (levonorgestrel intrauterine device (LNG), CuT 380Ag, CuT 220C and CuT 200B). A 36-month study. Indian Council of Medical Research Task Force on IUD. Contraception 1989; 39:37.
Meirik O, Rowe PJ, Peregoudov A, et al. The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial. Contraception 2009; 80:133.
Jensen JT, Nelson AL, Costales AC. Subject and clinician experience with the levonorgestrel-releasing intrauterine system. Contraception 2008; 77:22.
Nelson, AL, Hatcher, RA, Zieman, M, et al. Managing Contraception. Tiger, Georgia: Bridging the Gap Foundation, 2000.
Rönnerdag M, Odlind V. Late bleeding problems with the levonorgestrel-releasing intrauterine system: evaluation of the endometrial cavity. Contraception 2007; 75:268.
Ozalp S, Kabukcuoglu S, Tanir HM. Should endometrial hyperplasia be regarded as a reason for abnormal uterine bleeding in users of the intrauterine contraceptive device? Eur J Contracept Reprod Health Care 2003; 8:17.
Tsanadis G, Kalantaridou SN, Kaponis A, et al. Bacteriological cultures of removed intrauterine devices and pelvic inflammatory disease. Contraception 2002; 65:339.
Milsom I, Andersson K, Jonasson K, et al. The influence of the Gyne-T 380S IUD on menstrual blood loss and iron status. Contraception 1995; 52:175.
Rönnerdag M, Odlind V. Health effects of long-term use of the intrauterine levonorgestrel-releasing system. A follow-up study over 12 years of continuous use. Acta Obstet Gynecol Scand 1999; 78:716.
Hidalgo M, Bahamondes L, Perrotti M, et al. Bleeding patterns and clinical performance of the levonorgestrel-releasing intrauterine system (Mirena) up to two years. Contraception 2002; 65:129.
Nilsson CG, Lähteenmäki PL, Luukkainen T. Ovarian function in amenorrheic and menstruating users of a levonorgestrel-releasing intrauterine device. Fertil Steril 1984; 41:52.
Faúndes A, Alvarez F, Díaz J. A Latin American experience with levonorgestrel IUD. Ann Med 1993; 25:149.
Backman T, Huhtala S, Blom T, et al. Length of use and symptoms associated with premature removal of the levonorgestrel intrauterine system: a nation-wide study of 17,360 users. BJOG 2000; 107:335.
Farley TM, Rosenberg MJ, Rowe PJ, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992; 339:785.
Lee NC, Rubin GL, Borucki R. The intrauterine device and pelvic inflammatory disease revisited: new results from the Women’s Health Study. Obstet Gynecol 1988; 72:1.
Walsh T, Grimes D, Frezieres R, et al. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet 1998; 351:1005.
Grimes DA. Intrauterine device and upper-genital-tract infection. Lancet 2000; 356:1013.
Toivonen J, Luukkainen T, Allonen H. Protective effect of intrauterine release of levonorgestrel on pelvic infection: three years’ comparative experience of levonorgestrel- and copper-releasing intrauterine devices. Obstet Gynecol 1991; 77:261.
Feldblum PJ, Caraway J, Bahamondes L, et al. Randomized assignment to copper IUD or depot-medroxyprogesterone acetate: feasibility of enrollment, continuation and disease ascertainment. Contraception 2005; 72:187.
World Health Organization (WHO). Improving access to quality care in family planning. In: Medical Eligibility criteria for contraceptive use. 3rd ed, Geneva, Switzerland, 2003.
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Larsson B, Wennergren M. Investigation of a copper-intrauterine device (Cu-IUD) for possible effect on frequency and healing of pelvic inflammatory disease. Contraception 1977; 15:143.
Söderberg G, Lindgren S. Influence of an intrauterine device on the course of an acute salpingitis. Contraception 1981; 24:137.
Teisala K. Removal of an intrauterine device and the treatment of acute pelvic inflammatory disease. Ann Med 1989; 21:63.
Altunyurt S, Demir N, Posaci C. A randomized controlled trial of coil removal prior to treatment of pelvic inflammatory disease. Eur J Obstet Gynecol Reprod Biol 2003; 107:81.
Murray S, Hickey JB, Houang E. Significant bacteremia associated with replacement of intrauterine contraceptive device. Am J Obstet Gynecol 1987; 156:698.
Shoubnikova M, Hellberg D, Nilsson S, Mårdh PA. Contraceptive use in women with bacterial vaginosis. Contraception 1997; 55:355.
Hodoglugil NN, Aslan D, Bertan M. Intrauterine device use and some issues related to sexually transmitted disease screening and occurrence. Contraception 2000; 61:359.
Persson E, Holmberg K, Dahlgren S, Nilsson L. Actinomyces israelii in the genital tract of women with and without intra-uterine contraceptive devices. Acta Obstet Gynecol Scand 1983; 62:563.
Fiorino AS. Intrauterine contraceptive device-associated actinomycotic abscess and Actinomyces detection on cervical smear. Obstet Gynecol 1996; 87:142.
Keebler C, Chatwani A, Schwartz R. Actinomycosis infection associated with intrauterine contraceptive devices. Am J Obstet Gynecol 1983; 145:596.
Lippes J. Pelvic actinomycosis: a review and preliminary look at prevalence. Am J Obstet Gynecol 1999; 180:265.
Westhoff C. IUDs and colonization or infection with Actinomyces. Contraception 2007; 75:S48.
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Sudhakar SS, Ross JJ. Short-term treatment of actinomycosis: two cases and a review. Clin Infect Dis 2004; 38:444.
Merki-Feld GS, Lebeda E, Hogg B, Keller PJ. The incidence of actinomyces-like organisms in Papanicolaou-stained smears of copper- and levonorgestrel-releasing intrauterine devices. Contraception 2000; 61:365.
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Venkataramanasetty R, Aburawi A, Phillip H. Streptococcal toxic shock syndrome following insertion of an intrauterine device–a case report. Eur J Contracept Reprod Health Care 2009; 14:379.
Gisser JM, Fields MC, Pick N, et al. Invasive group a streptococcus associated with an intrauterine device and oral sex. Sex Transm Dis 2002; 29:483.
Turok DK, Gurtcheff SE, Gibson K, et al. Operative management of intrauterine device complications: a case series report. Contraception 2010; 82:354.
Yegüez JF, Martinez SA, Sands LR, Hellinger MD. Pelvic actinomycosis presenting as malignant large bowel obstruction: a case report and a review of the literature. Am Surg 2000; 66:85.
Nugteren SK, Ouwendijk RJ, Jonkman JG, et al. Colitis and lower abdominal mass by Actinomyces israelii in a patient with an IUD. Neth J Med 1996; 49:73.
Sivin I. Utility and drawbacks of continuous use of a copper T IUD for 20 years. Contraception 2007; 75:S70.
Moschos E, Twickler DM. Intrauterine devices in early pregnancy: findings on ultrasound and clinical outcomes. Am J Obstet Gynecol 2011; 204:427.e1.
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Topic 5422 Version 30.0
While women are filing lawsuits for Mirena IUD injury a new Bayer IUD is approved. We receive calls daily from women suffering with side effects from Bayer’s Mirena IUD and yet science moves on and a new Bayer IUD is approved.
FDA Approves Bayer HealthCare (BAY)’s First New IUD in 12 Years
WAYNE, N.J., Jan. 9, 2013 /PRNewswire/ — Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg, a new hormone-releasing system that is placed in the uterus for the prevention of pregnancy for up to three years.
“Research shows that nearly 50 percent of pregnancies in the U.S. are unintended,2 which emphasizes the need for increased education and access to effective birth control options,”said Anita L. Nelson, M.D., Professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. “Skyla is more than 99 percent effective at preventing pregnancyand may be appropriate for women who want a birth control method that they do not have to take daily. Further, Skyla may be used by women whether or not they have ever had a child, representing an important new choice for women who don’t want to become pregnant for up to three years.”
Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a progestin hormone called levonorgestrel.The size of the Skyla T-body is 28mm x 30mm and the outer diameter of the placement tube is 3.8mm. Because Skyla slowly releases levonorgestrel into the uterus, only small amounts of the hormone enter the blood. During the first three to six months of using Skyla, women may experience irregular periods and an increase in the number of bleeding days. Women may also have frequent spotting or light bleeding. Some women may have heavy bleeding during this time. After using Skyla for a while, the number of bleeding and spotting days is likely to lessen, and there is a small chance that periods may stop altogether.1,3
Women can have Skyla placed by a healthcare provider during an in-office visit. Skyla is intended for long-term use for up to three years but may be removed by a healthcare provider at any time. Women could become pregnant as soon as Skyla is removed, so they should use another method of birth control if they do not want to become pregnant. About 77% of women who want to become pregnant will become pregnant sometime in the first year after Skyla is removed.3
“The approval of Skyla expands Bayer’s IUD portfolio and highlights our continued commitment to empower women with a variety of birth control options at different reproductive stages of their lives,” said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “We are pleased to bring the first new IUD to market in the U.S. in 12 years, and to provide women who are seeking contraception with an important new and effective option to consider with their healthcare providers.”
Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of February 11.
About the Clinical Trial for Skyla1
The approval of Skyla is supported by data from a Phase 3 trial that included 1,432 women aged 18-35 who received Skyla, of which 38.8% (556) had not yet had a child. The trial was a multicenter, multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the U.S. and Canada. Women less than six weeks postpartum, with a history of ectopic pregnancy, with clinically significant ovarian cysts or with HIV or otherwise at high risk for sexually transmitted infections were excluded from the trial.
The pregnancy rate calculated as the Pearl Index (PI) in women aged 18-35 years was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. Skyla-treated women provided 15,763 evaluable 28-day cycle equivalents in the first year and 39,368 evaluable cycles over the three-year treatment period. The PI estimate for the first year of use based on the five pregnancies that occurred after the onset of treatment and within seven days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative three-year pregnancy rate, based on 10 pregnancies, estimated by the Kaplan-Meier method was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.
Of Skyla-treated women, 21.9% discontinued the study treatment due to an adverse event. Most common adverse reactions (occurring in greater than or equal to 5% users) were, vulvovaginitis (20.2%), abdominal/pelvic pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache (12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased bleeding (7.8%) and nausea (5.5%).
Other serious adverse reactions were also observed, including ectopic/intrauterine pregnancy, life-threatening infections, pelvic inflammatory disease (PID), perforation and expulsion.
Important Safety Information for Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg
If you have a pelvic infection, get infections easily, or have certain cancers, don’t use Skyla. Less than 1% of users get a serious infection called pelvic inflammatory disease.
If you have persistent pelvic or stomach pain or if Skyla comes out, tell your doctor. If Skyla comes out, use back-up birth control. Skyla may attach to or go through the uterus and cause other problems.
Pregnancy while using Skyla is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur but usually disappear.
Bleeding and spotting may increase in the first few months, and remain irregular. Over time, periods are likely to become shorter and lighter, or may stop.
Skyla does not protect against HIV or STDs.
Only you and your healthcare provider can decide if Skyla is right for you. Skyla is available by prescription only.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For additional information about Skyla, please see full prescribing information at www.skyla-us.com.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
BAYER® and the Bayer Cross® are registered trademarks of Bayer. Skyla is a trademarkof Bayer.
The Two Compared
Initial levonorgestrel release rate is 20 mcg/day; rate reduced by 50% after 5 years
Must be removed or replaced after 5 years
Levonorgestrel release rate is 14 mcg/day after 24 days and 5 mcg/day after 3 years
Must be removed or replaced after 3 years
The Mirena IUD Helpline is beginning the national outreach campaign with the sunshine state to start this mission to locate all women with perforations from the Mirena IUD. The devise is migrating from position and becoming lodged or embedded in the Uterus or intestines. This results in a perforation, must be surgically removed by a physicians and results in infertility.
The Mirena IUD Helpline has a mission to locate all Florida women with severe complications from the Mirena IUD where the IUD must be surgically removed. This expanded outreach includes the entire state of Florida and Miami, Homestead, Florida Keys, Fort Lauderdale, Boca Raton, West Palm Beach, Delray Beach, Boynton Beach, Port St Lucie, Okeechobee, Melbourne, Titusville, Daytona, Jacksonville, Ocala, Orlando, Kissimmee, Ft Myers, Winter Park, Naples, Tampa, Clearwater, St Petersburg, New Port Richey, Pensacola, Panama City, Tallahassee and all of Florida. According to the helpline MSW, “We have particular concern for women who have had the IUD surgically removed. The result for many is permanent disability. These women are of child bearing age. The horrors of the Mirena IUD must reach the FDA amd women must be protected.”
The Mirena IUD Helpline is encouraging all women who have had a uterus perforation to file their Mirena IUD lawsuits. The Mirena IUD Helpline is targeting the entire state of Florida as a part of the expanded Florida campaign with hopes of locating all women with permanent injury from the Mirena IUD. It is important that women file their Mirena lawsuits immediately.