The U.S. Food & Drug Administration (FDA) on Monday said it will begin restricting sales of Bayer’s Essure contraceptive amid thousands of reports of adverse health complications including back and pelvic pain, bleeding, organ perforation, migration of the contraceptive, ectopic / unwanted pregnancy, miscarriage and death.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by Essure side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the problem?
April 11, 2018 – Since the Essure implant was approved by the U.S. Food & Drug Administration (FDA) in Nov. 2002, thousands of lawsuits have been filed against Bayer, filed on behalf of women who claimed they suffered severe, and in some cases, life-threatening injuries.
FDA in 2016 declined to recall Essure, instead ordering Bayer to place a “black box” warning on the device’s labeling indicating that it may increase the risk of serious side effects. The warning also states that Essure can migrate from the implant site into the abdomen and/or pelvic cavity, causing pain and possibly requiring surgical removal.
Essure consists of a pair of coils made of nickel and polyester-like fiber which are implanted in the fallopian tubes through the vagina, which creates an inflammatory response that causes scar tissue to block the tubes. Unlike most other birth control devices, Essure is meant be permanent.
FDA said on Monday that it has received at least 26,773 adverse events associated with Essure since it was approved, although some of the reports may be duplicates.
The most frequently reported problems included pain, menstrual irregularities, and headache, FDA said. There were also reports of pregnancy loss, ectopic pregnancy, and deaths associated with Essure.
The action announced on Monday will require doctors to ensure that patients sign a form with a checklist acknowledging that they have been advised of Essure’s risks, and also require the doctor’s signature.
Do I Have an Essure Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Essure lawsuits. We are handling individual litigation nationwide and currently accepting new contraceptive injury cases in all 50 states.
Free Case Evaluation: Again, if you were harmed by Essure or another birth control device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.