• The Mirena IUD is Manufactured by Bayer...
    ...the same company that has indicated to shareholders that it will reserve an additional $262.5 million to settle Yaz and Yasmin lawsuits over blood clots
  • Call the Mirena IUD Helpline and speak to a female medical social worker and a Mirena IUD lawyer
  • The Mirena IUD has had serious complications
    • Perforation of the uterus
    • The IUD can gravitate and become embedded in the uterus or abdomen
    • Pregnancy even with the Mirena inserted
    • Gravitation of the IUD, change in position
    • Ectopic pregnancy
    • Group A streptococcal sepsis
    • Infertility when the IUD becomes embedded
    • Need for surgical removal of the Mirena
  • The Mirena IUD is a flexible intrauterine device that is placed into the uterus through the vagina by a GYN. Mirena releases a continuous dose of hormones (levonorgestrel) to prevent pregnancy for up to five years.
  • Over 2 million women in the U.S. have used Mirena IUD for birth control.
    Mirena is one of the most common IUDs currently on the market.
  • Uterine Perforation Symptoms From the Mirena: If you have these symptoms see a physician immediately.
    • Lower abdominal pain
    • Heavy vaginal bleeding
    • Inability to locate the Mirena IUD string
    • Bloating, rigidity and pain in the abdomen
    • Nausea, Vomiting, Chills, Fever, Rapid heartbeat

Mirena Perforation Lawsuits, Laproscopic Surgical Removal Lawsuit Lawyers

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

We are no longer accepting Mirena IUD Lawsuits

Attention Ladies: Mirena IUD lawyers are filing lawsuits where your device migrated, become embedded in and perforated your uterus and was  removed with laproscopic surgery.

Laparoscopic surgery is a minimally-invasive type of surgery that utilizes a tool called a laparoscope, which has a light, video camera, and surgical instruments on the end. A surgeon watches a video monitor to guide surgery. The benefit of this surgery is that it minimizes risks during surgery, reduces pain, and reduces recovery time.

 Ladies with a Perforation from Your Mirena IUD
Lawyers are filing Mirena IUD lawsuits for perforations where the device must be laproscopically removed.

If your Mirena IUD moved, migrated or gravitated out of the original insertion position after a followup found everything was ok we need to hear from you ASAP  to have your case reviewed for a  MIRENA IUD  Lawsuit .

Mirena IUD Lawsuit Alert, What You Need To Know To File A Mirena Lawsuit

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Mirena IUD Uterine Perforation Lawyers

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:

1. Mirena  IUD must be the product implanted
2. You must have gone to  your 4-6week follow up appointment the and doctor has confirmed that your Mirena IUD  was properly implanted
3. The Mirena IUD has perforated uterus or other organ. The Mirena must have moved out of position, gravitated and has become embedded  in your uterus or an organ and/or  there is a perforation injury.
 4. This usually means the Mirena , needs to be or will be surgically removed
A lot of Mirena women either don’t go to follow up appointment or by the time they go to follow up the mirena has already moved. If that happens this becomes a med mal issue and not a products issue. The statute of limitations starts to run when you knew mirena perforated an organ.
To find out more about the Mirena IUD lawsuits call the Mirena IUD Helpline. Mirena IUD Helpline  lawyers are accepting  Mirena side effect cases  for embedment in the uterine wall, uterine bleeding and IUD expulsion.  Mirena lawyers are offering a free consultation to women suffering from the Mirena IUD.

Mirena News Update, MDL Hopes For Mirena IUD, March 21st Hearing

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

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.

Mirena IUD Hopes For A Mirena Lawsuit MDL, Mirena IUD Lawsuit MDL Update

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

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.


Mirena IUD Lawsuit Moves Forward, Mirena IUD Helpline Watches

Written by Mirena IUD Helpline on . Posted in Mirena IUD Helpline, Mirena IUD Lawsuit News

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.



Women”s Dangerous Drug snd Devices Helpline Update

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Mirena Stories and Sharing


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 Help, Mirena IUD Florida Resources, Florida Mirena Lawyer

Written by Mirena IUD Helpline on . Posted in Florida Mirena IUD resources, Mirena IUD Helpline, Mirena IUD Lawsuit News

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

Boca Raton

8177 Glades Rd.

Bay 25

Boca Raton, FL 33434

P: 561.226.4116

F: 561.939.1344

Manatee Health Center, Bradenton

1105 53rd Avenue East, Suite 201

Bradenton, FL 34203

P: 941.567.3800

F: 941.753.3804

Fort Myers Health Center, Ft. Myers

8595 College Parkway, Suite 250

Ft. Myers, FL

P: 239.481.9999

F: 239.481.9346

Gainesville Health Center, Gainesville

914 NW 13th Street

Gainesville, FL 32601

P: 352.377.0881

F: 352.374.6823

Immokalee Center, Immokalee

419 N First Street

Immokalee, FL 34142

P: 239.262.0301

F: 239.262.7658

Jacksonville Health Center, Jacksonville

3850 Beach Blvd

Jacksonville, FL 32207

P: 904.399.2800

Lakeland Health Center

2250 E Edgewood Drive

Lakeland, FL 33803

P: 863.665.5735

F: 863.665.4422

Jean Shehan Health Center, Miami

3119A SW 22nd Street

Miami, FL 33145

P: 305.285.5535

F: 305.285.6956

Kendall Health Center, Miami

11440 SW 88th Street, Suite 109

Miami, FL 33176

P: 786.263.0001

F: 786.263.0004

7900 N.W. 27 Ave. #E240

Miami, FL 33147

P: 305.423.7933

F: 786.517.6138

Naples Center, Naples

1425 Creech Road

Naples, FL 34103

P: 239.262.0301

F: 239.262.7658

North Miami Health Center, North Miami

681 N.E. 125 Street

North Miami, FL 33161

P: 305.895.7756

F: 305.895.7763

Orlando – Eastside Clinic

11500 University Blvd

Suite B

Orlando, FL 32817

P: 321.235.5513

F: 321.235.6125

Orlando Westside Clinic, Orlando

726 South Tampa Ave

Orlando, FL 32805

P: 407.246.1788

F: 407.246.8466

Pembroke Pines Health Center, Pembroke Pines

263 North University Drive

Pembroke Pines, FL 33024

Sarasota Health Center

736 Central Avenue

Sarasota, FL 34236

P: 941.953.4060

F: 941.366.1899

Pinellas Health Center, St. Petersburg

8950 Dr. Martin Luther King Jr. Street North, Suite 102

St. Petersburg, FL 33702

P: 727.898.8199

Martin County Health Center, Stuart

1322 NW Federal Hwy., Emerald Plaza

Stuart, FL 34994

P: 772.692.2023

F: 772.692.1555

The Sally Bellamy Health Center, Tallahassee

2121 W Pensacola Street


Tallahassee, FL 32304

P: 850.574.7455

F: 850.575.4335

Tampa Health Center, Tampa

8068 North 56th Street

Tampa, FL 33617

P: 813.980.3555

F: 813.341.1111

Indian River (Vero Beach) Health Center, Vero Beach

3106 20th Street

Vero Beach, FL 32960

P: 772.778.0037

F: 772.778.1050

Wellington Health Center, Wellington

10111 Forest Hill Blvd, Suite 340

Wellington, FL 33414

P: 561.296.4919

F: 561.721.3474

West Palm Beach Health Center

931 Village Blvd. Suite 904

West Palm Beach, FL 33409

P: 561.683.0302

F: 561.683.9823

Winter Haven Health Center, Winter Haven

908 Havendale Blvd

Winter Haven, FL 33881










Overview Of Mirena IUD Complications, Medical Perspective

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

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

Section Editor

Mimi Zieman, MD

Deputy Editor

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]:




Severe dysmenorrhea

Prior expulsion

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 [6].


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 [9].


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 [10], 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 [11].


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 [13]. 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 [10]. 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 [19]. 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 [20]. 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 [21]. 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 [22] or by paracervical block, either alone or in combination with conscious sedation [23]. The cervix can be softened, if needed, with misoprostol in order to facilitate the procedure [23]. 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 [20]. 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 [4]. 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 [24]. (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 [29].


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 [30]. 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 [33]. 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 [39]. 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)’.) [46].


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 [48].


Chronic endometritis is a common finding in endometrial biopsies of women who have used an IUD for more than five years [47]. 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 [40]. 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 [41]. 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 [50]. 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 [51]. 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 [33].




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 [55]), 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 [33]. 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 [59]. Although the copper IUD does not offer this same protection, it does not appear to increase the risk of PID or of serious infection [60].


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 [61]) 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 [66]. 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 [67]. 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 [33]. (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 [70]. 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 [73].


Approximately 7 percent of women using an IUD have actinomyces-like organisms on a Papanicolaou (Pap) test [74]; 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 [24]. 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 [75], 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 [76]; 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 [74].


The LNg IUD seems to have a lower incidence of actinomyces-like organisms noted on Pap smear than copper IUDs [77].


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 [81]. 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 [84]. For the LNg IUD (Mirena®), efficacy may decrease after five years and is only proven through seven years [41]. 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 [2]. Malposition of the IUD is a risk factor (picture 1) [85].


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 [86].


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 [87]. 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 [4]. 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 [88]. Removal of the IUD may cause rupture of membranes, bleeding, pregnancy loss, or fetal trauma [94]; 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 [95]. 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 [97].


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 [59]. 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 [59]. 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 [103].


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)”)




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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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.

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Nilsson CG, Lähteenmäki PL, Luukkainen T. Ovarian function in amenorrheic and menstruating users of a levonorgestrel-releasing intrauterine device. Fertil Steril 1984; 41:52.

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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.

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Topic 5422 Version 30.0


Mirena IUD Helpline Launches Florida Mirena Outreach Campaign

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

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.



Physicians Are Arrested For Implanting Unapproved IUD’s

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

While Bayer is being sued for not releasing appropriate warning and women being injured by it’s Mirena IUD physicians are being arrested for implanting unapproved IUD’s. At the Mirena IUD Helpline we are always interested in sharing news with  our readers. This caught my eye browsing the web.

Gotten From Medscape Medical News

Physicians Risk Lawsuits, Prison for Using Unapproved IUDs


Robert Lowes

Jul 29, 2010





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July 29, 2010 — The issue of whether or not Congress should legalize the importation of lower-cost drugs and devices from Canada is no academic matter when physicians do the importing.


For them, the subject can turn into a legal and regulatory hell, with federal prosecutors, state health officials, and plaintiffs’ attorneys stoking the fire.


Dozens of obstetrician-gynecologists (ob/gyns) in Rhode Island, for example, are on the hot seat for buying and implanting intrauterine devices (IUDs) from Canada that lack approval by the US Food and Drug Administration (FDA).


The physicians have already started to experience what has happened to ob/gyn Kelly Dean Shrum, DO, in Pine Bluff, Arkansas — a veritable test case for the importation controversy. Understanding his story requires a look at medical economics.


Ob/gyns such as Dr. Shrum typically buy the IUDs they implant in patients. If a patient is insured, an ob/gyn then bills the insurer to recoup what he or she paid for the IUD. It often is not a break-even proposition. When Arkansas ob/gyns, for example, implant a levonorgestrel-releasing Mirena IUD (Bayer Healthcare Pharmaceuticals) in a Medicaid recipient, the state reimburses them roughly $448 for the device. Ob/gyns lose money on the procedure because they have to pay $700 to $800 for the IUD, assuming it is the FDA-approved version, which is the only legal version to use in this country.


However, they can buy a Mirena IUD that lacks FDA approval from Canadian pharmacies for a little more than $200. By going with the less-expensive version, these physicians avoid losing money on the IUD procedure and instead earn a modest profit that subsidizes their care of Medicaid patients. After all, Medicaid programs across the country pay so little that many physicians turn away such patients, lest they go broke.


Conviction on Criminal Charges Could Mean Prison


The Canadian price break comes with a big risk. In June 2009, FDA agents found unapproved Mirena IUDs in Dr. Shrum’s office — a discovery that triggered criminal and civil charges.


Last October, a federal grand jury indicted Dr. Shrum with drug misbranding, healthcare fraud (for billing the state Medicaid program for unapproved IUDs), and 3 counts of money laundering (for depositing money from an allegedly illegal activity in his bank account). Dr. Shrum faces a maximum penalty of 3 years in prison and a $10,000 fine for misbranding, and a maximum of 10 years in prison and a $250,000 fine for healthcare fraud and for each count of money laundering, according to federal prosecutors.


In addition, former patients have filed a class-action suit against Dr. Shrum in a state court. They allege that by implanting unapproved IUDs in them without their consent, Dr. Shrum is at fault for medical negligence, unjust enrichment, violation of the state’s law against deceptive trade practices, and breach of fiduciary duty.


However, Dr. Shrum may not have the support of his malpractice insurer in the class-action case. That insurer, State Volunteer Mutual Insurance, sued Dr. Shrum and the class-action plaintiffs in an Arkansas federal court, looking for a declaration that it is not responsible for either defending Dr. Shrum or covering his damages, given the nature of his case.


“He Never Risked Their Safety”


Dr. Shrum, who is contesting the charges against him, did not grant an interview to Medscape Medical News, nor did his attorney, Charles Hicks. However, in a press release, Hicks stated that thousands of ob/gyns, orthopedic surgeons, oncologists, and other physicians obtain Mirena IUDs and other drugs and devices from licensed Canadian pharmacies. They do so to “legitimately reduce unnecessary healthcare costs that are greatly increased by pharmaceutical companies charging Americans the highest prices in the world for their medications.


“Dr. Shrum wants his patients to know that they are not in any danger and he never risked their safety,” Hicks said. “There is no threat to the public safety, and instead, the only conceivable harm is to Bayer’s profits.”


He noted that all Mirena IUDs are manufactured in a plant in Finland. What made Dr. Shrum’s IUDs “unapproved,” Hicks said, was that they were purchased at a lower price than what Bayer distributors sold them for in the United States and were packaged differently.


“It is unfortunate that the government is using our criminal justice system to line the pockets of a multinational, for-profit company,” he said.


“Identical” Products May Not Live Up to Billing


The issue of unapproved IUDs took center stage last week when the FDA issued a letter to healthcare providers warning them not to use such devices. In addition to the Mirena IUD, the letter listed unapproved versions of the IUDs Implanon (Schering-Plough) and ParaGard (DuraMed Pharmaceuticals), both of which have received FDA approval, as well as T-Safe (Eurim Pharm), which is not FDA-approved.


Patients are exposed to unacceptable risks when a product’s “identity, purity, source, handling, and storage cannot be verified,” writes Theresa Toigo, director of the agency’s Office of Special Health Issues, in the letter.


The FDA contends that imported drugs and devices advertised as being identical to FDA-approved products may instead be bogus, unsafe, and ineffective. Even if the product is identical, it may not satisfy FDA requirements for manufacturing, storage, shipping, and labeling that were imposed as part of the approval process here. Patient information also may be in a language other than English — an allegation made by federal prosecutors about Dr. Shrum’s use of Mirena IUDs.


In a statement issued to Medscape Medical News, a spokesperson for Bayer Healthcare Pharmaceuticals noted a variety of differences in Mirena IUDs approved for distribution in various countries.


“Only Mirena that is approved for sale and use in the U.S. includes FDA-approved full prescribing information and a patient information booklet, which includes a patient consent form with a specific lot number that becomes part of the patient record,” said Bayer spokesperson Rose Talarico. “The lot number can help the company identify and communicate with specific patients in the event of important safety updates or product recalls. Non-FDA approved Mirena would not include this information and any information may be in a foreign language.”


Talarico also said that there are product differences in the Mirena IUD itself from country to country, such as the length of the thread used to load the IUD into the insertion tube.


Rhode Island Health Department Cracks Down on 10 Ob/Gyn Practices


The FDA last week announced that it was investigating reports of physicians in Rhode Island and other states implanting unapproved IUDs. Even without the federal agency taking action against them, several dozen Rhode Island ob/gyns are in enough trouble as it is.


The Rhode Island Department of Health reports that 10 ob/gyn practices, including 4 group practices, have admitted to either purchasing or implanting nonapproved IUDs such as Mirena and ParaGard. The department estimates that 1 group practice alone implanted unapproved IUDs in 400 to 500 women.


The state health department recently ordered the 10 practices to, among other actions:


surrender their stockpiles of unapproved IUDs;


notify each patient who received an unapproved IUD;


turn over the names of these patients, along with their medical and billing records, to the state; and


turn over the names of patients who had an unapproved IUD taken out.


The state has referred all the involved physicians, nurse practitioners, and certified nurse midwives to their respective licensing boards, creating a chain reaction of governmental scrutiny.


Private insurers that reimbursed Rhode Island physicians for unapproved IUDs have their hackles up as well. Blue Cross and Blue Shield of Rhode Island, for example, told Medscape Medical News that it expects these physicians to return the fees they received and to assume financial responsibility for removing the IUDs from patients.


Meanwhile, several Rhode Island patients who received unapproved IUDs have taken a cue from their counterparts in Arkansas and filed a class-action suit against the 4 group practices identified by the state health department, 34 individual Rhode Island physicians, and 16 certified nurse midwives and nurse practitioners. The litany of accusations includes battery, based on the insertion of an unapproved contraceptive device without the patient’s informed consent.


Physicians Did Hard Time in Bogus Botox Cases


Federal prosecutors have not filed criminal charges — and may never do so — against the Rhode Island clinicians similar to the sort Dr. Shrum is battling. However, the FDA has a track record for coming down hard on those who traffic in unapproved drugs and medical devices.


In 2004, for example, the FDA Office of Criminal Investigations looked into a case of 4 Florida patients who developed temporary paralysis after they were injected with an unapproved, cheaper version of FDA-approved botulinum toxin type A (Botox Cosmetic; Allergan) made in the United States. The dragnet spread across the country and by July 2008, the FDA had racked up 29 convictions of healthcare professionals who had knowingly treated some 1000 patients with bogus Botox. Most of these clinicians had misled patients about the authenticity of the product, according to the FDA.


A sampling of the convicted individuals posted on the FDA Web site includes 5 physicians, all of whom received prison sentences.