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Essure Birth Control Implant Issued a Black Box Warning from FDA but Remains on the Market

Posted on in Medical Malpractice

Chicago defective medical device lawyersOver the last decade, an estimated 750,000 women have received the Essure birth control implant. Thousands have reported health complications, some of which were life-altering. In response, the U.S. Food and Drug Administration has moved to issue a “black box” warning – their most serious type – for Essure. Yet the devices remain on the market. If you or someone you love has the Essure implant, the following information covers what you should know about the possible risks, and what you can do, should you experience any of them.

Current Warning Label and Potential Complications

Pitched as the only non-surgical permanent birth control option, Essure consists of two nickel-titanium coils. They are implanted into the fallopian tubes, through the cervix, during a 15-minute procedure. Within three months, scar tissue is supposed to develop around the coils, preventing the fallopian tubes from releasing eggs into the uterus. Until a follow-up check at that three-month mark, women are told to use alternative forms of contraception to prevent pregnancy. The device’s current warning says women may experience pelvic pain and bleeding immediately after the procedure.

Unfortunately, many women claim they have experienced intense pain and bleeding long after the procedure. For some, the pain and bleeding was so severe that they eventually underwent surgery to have the implants removed. Some have experienced pregnancy, and others claim the device caused them to experience unlisted complications, such as hair loss, mood disorders, psoriasis, and lupus. There are also concerns over migrating devices that may adhere to or rupture the uterus, fallopian tubes, or other areas inside the body.

Bayer Insists Implant is Safe

Bayer, the maker of the Essure birth control, claims that the product is safe, and that any complications that have arisen are either due to poor implantation by the physician or failure to follow instruction by the patient (i.e. not using an alternative form of birth control during the first three months). The FDA seems to agree, considering they have chosen to issue a black box warning on the devices rather than simply pull them from the market. Then again, the agency is also mandating additional studies to determine the overall safety of the device. This suggests the verdict is not yet in. As such, women should be wary of any possible and unlisted complications.

Get Experienced Legal Assistance with Your Case

Because every case is unique, it is important that each one be evaluated by an experienced Chicago defective drug attorney. Turn to Hurley McKenna & Mertz, P.C., where your rights are protected and your best interests are a priority. Backed by more than 75 years of experience, we provide personalized services for all medical malpractice cases. Schedule your free consultation to learn more. Call us at 312-553-4900 today.

Sources:

http://www.cbsnews.com/news/fda-warning-essure-birth-control-implant/

http://www.foxnews.com/health/2016/02/29/fda-asks-for-more-studies-on-bayers-essure-contraceptive-implant.html

https://www.washingtonpost.com/news/to-your-health/wp/2016/02/29/fda-requires-black-box-warning-but-leaves-controversial-essure-implant-on-market/

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