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A number of women throughout the United States are reporting serious and potentially life-threatening health complications from Essure, a permanent form of birth control that has been believed to be fairly safe.
Essure birth control is a transcervical sterilization procedure, which is marketed as a less expensive, easier and safer alternative to tubal ligation surgery. However, hundreds of women are reporting severe Essure side effects following the procedure, causing many to opt for a hysterectomy.
The FDA has logged more than 850 reports of adverse side effects since 2004, which suggests that thousands of problems have been experienced, since it is widely acknowledged that only about 1% to 10% of all adverse events are ever reported to the FDA.
Among reports submitted to the federal regulatory agency are more than 150 Essure complications involving the device moving and puncturing fallopian tubes or the uterus, with nearly 100 women requiring hysterectomies to remove Essure birth control following severe complications. In addition, at least 150 reports have been filed involving doctors complaining of the device breaking during insertion and numerous other problems with allergic reactions and side effects.
Following increasing concerns, the FDA posted new information to their website on October 18, outlining the results of their own investigation into the Essure problems, including a review of a five-year post-approval study, complaints through the MedWatch Adverse Event Reporting System and web-based testimonials.
The FDA has acknowledged the complications experienced by a number of women, but indicates that many were seen in clinical trials and are addressed on the product’s labeling, such as pain. However, the agency did note that some of the complaints, included depression, extreme fatigue, and weight gain, were not seen during clinical trials.
“We evaluated the available clinical literature to determine what long-term complications may be associated with Essure more than five years after placement, because the post-approval study only evaluated safety and effectiveness up to five years,” the FDA review states. “To date, we have found no evidence in the literature indicating any new or more widespread complications definitely associated with Essure occurring more than five years after Essure placement.”
Essure birth control was first approved by the FDA in 2002. It was originally designed and manufactured by Conceptus, before recently acquired by the pharmaceutical giant Bayer. More than 750,000 women have undergone Essure birth control surgery, according to prior data released by Conceptus.
The birth control implant is offered as an outpatient procedure by many medical facilities. During the surgery, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process thus causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.
In recent months, increased media attention has been focused on reported Essure problems experienced by some women, including extreme abdominal pain, excess bleeding, rashes and bloating, and having internal organs removed as a result of side effects. Some women report pieces of the device have remained lodged in the uterus following removal of Essure.
Many women have taken to social media and the internet to share and log their complaints. Some describe the pain as similar to having “daily period cramps” and others report the pain is as severe as “contractions of labor pains” where physical movement often makes the pain worsen.
The manufacturers of Essure have cited clinical studies focused on the safety of the procedure. The FDA has indicated that any women who have experienced Essure complications should submit a report to its MedWatch adverse event reporting program.