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The Food and Drug Administration has announced plans for a meeting of their Obstetrics and Gynecology Devices Panel to discuss the safety and effectiveness of the Essure birth control device.
Background on Essure
Essure
is an implantable contraceptive device meant to be a non-surgical alternative to tubal ligation surgery for women seeking permanent birth control. It consists of a flexible metal and polyester coil that is inserted into the fallopian tube. The presence of the implant stimulates growth of scar tissue around it, and after about three months, enough tissue will have built up to block the passage of sperm, thus preventing it from reaching the eggs.
Conceptus Pharmaceuticals developed Essure and received FDA approval for the device in November 2002. The simplicity of the implantation procedure was Essure’s big selling point when it was originally introduced, since a doctor can perform the procedure in about 10 minutes in a clinical office. In 2013, Bayer Pharmaceuticals purchased a controlling share in Conceptus and now controls the manufacturing and distribution of the device. As many as 750,000 different women in 23 countries have received Essure implants.
Essure Complications
The negative attention Essure has recently received arises from the increasing number of complaints to the FDA from women reporting harmful Essure complications. According to the FDA, the most frequently reported Essure complications are abdominal pain, irregular menstruation, headache, fatigue, and weight fluctuations. Some patients have also reported severe back and pelvic pain. In some cases, the device has broken or migrated from the place it was originally implanted. In one case, the recipient died reportedly due to perforation of the uterus during placement. Another patient died due to an air embolism during surgery to remove the device.
A few Essure implants have perforated the woman’s fallopian tube and migrated outside, lodging in the surrounding tissue. In some cases, surgery was required to remove the devices or to perform a traditional tubal ligation when the devices failed.
Some women who received Essure implants say they were not properly informed about the potential severity of Essure complications. Angie F. of New York, who received Essure in 2009, endured pain and unstoppable bleeding for two years afterward. Her doctors discovered that her implants had broken apart; removal of the fragments required a hysterectomy. She now says that if she had been better informed about the real risks of Essure complications, she would never have used Essure.
In 2011, Angie started a Facebook page to warn others about the danger of Essure complications. The page now has almost 17,000 members. Environmental activist Erin Brockovich has also started her own website, Essure Procedure, to provide a forum for women to share stories of their experiences with Essure complications.
An Essure lawsuit is the chosen avenue to receive compensation for a few women. One who participated in clinical trials in 2000 and who suffered painful menstruation, fatigue, migraines and joint pain has filed a $1 million claim against Bayer Pharmaceuticals. Other Essure lawsuits are expected to follow.
The FDA’s panel meeting is scheduled for Sept. 24, 2015. Presenters, panel members, and the general public are invited to submit relevant comments and recommendations before then.
In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.
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If you or a loved one were injured by Essure birth control complications, you may have a legal claim. See if you qualify to pursue compensation and join a free Essure class action lawsuit investigation by submitting your information for a free case evaluation.
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