FDA Requires “Black Box” Warning on Essure Label

Texas lawyer for Essure side effects, pain, bleeding, uterine perforation, and surgery.February 29, 2016 — The FDA has ordered new safety studies and a “Black Box” warning about serious risks associated with Essure, a sterilization device made by Bayer.

The FDA has been reviewing the risks of Essure since September 2015. After a five-month review, the agency issued draft guidance that included warnings about serious complications, such as:

However, the actions fell short of demands from lawmakers to ban Essure. U.S. Congressman Mike Fitzpatrick issued this statement:

“It’s unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and ask the manufacturer to perform another study while leaving Essure on the market.”

Essure is a permanent form of birth control for women. It is a matchstick-sized piece of plastic coated in irritating fibers and wrapped in metal coils. Essure is implanted into the fallopian tubes through the vagina, where it causes low-level inflammation and scarring that causes infertility.

Essure was marketed as an easy outpatient procedure for women who don’t want a hysterectomy. Instead, many were left with debilitating pain, bleeding, and other side effects. A study published in the British Medical Journal linked Essure to 10X increased risk of needing follow-up surgery compared to traditional “tube tying” sterilization.

Need an Essure Lawyer in Texas?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Essure lawyers for a free lawsuit review.

Free Case Review

Verified 100% Secure Site

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 879-3040.

*
*
*