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Black Box Warning Too Little Too Late for Essure

This is Amy German, Managing Associate attorney for the Michael Brady Lynch Firm.

After more than 5,000 women filed grievances with the FDA, complaining of unintended pregnancies, miscarriages, stillbirths, severe pain and bleeding, the FDA has finally woken up to the serious complications associated with Bayer’s Essure. The FDA said Essure is now required to have a black box warning label. This is one of the most serious labels a drug or product can possess, since it is specific to those, which carry life-threatening risks.

However, the FDA did not remove the device from the market like many are calling for. Instead, Dr. William Maisel, chief scientist for the FDA’s device center called for more rigorous research on the device. This new study will assess the risks of the device with over 2,000 women for at least 3 years. The FDA wants Bayer to concentrate on women who experienced unplanned pregnancies, pelvic pain and needed surgery to replace or remove the device. Also, this study will not be limited to women with Essure, but will compare women with Essure to other women who selected other methods of sterilization (e.g. tubal ligation).

Bayer and medical professionals pushed Essure as the non-surgical option to tubal ligation. Approved in 2002, Essure is a permanent form of birth control that uses nick-titanium coils, which are non-surgically inserted into a woman’s fallopian tubes. Scar tissue is supposed to form around the device to prevent sperm from reaching eggs to fertilize them. Bayer estimates 750,000 women have received the device since 2002.

In the next 60 days, the FDA is seeking public input on the language for the new black-box Essure warning along with suggestions for a checklist doctors will use to ensure that their patients understand the risks of Essure before implantation.

Finally, the FDA is taking strides to warn women of the serious side effects of Essure. If you or a loved one experienced one of these side effects, contact us today for a free consultation. 877-513-9517.

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