Essure Withdrawn From the Market
On July 20, 2018, the Food and Drug Administration was notified by Bayer that its permanent birth control device “Essure” will no longer be sold or distributed in the United States after December 31, 2018. The U.S. is the last country where Essure is being sold. Last September, citing “commercial reasons”, Bayer announced that it was ending sales outside the United States. The decision to halt Essure sales in the U.S. follows a patient safety action by the FDA in April 2018, in which the agency restricted the sale and distribution of Essure to women who were adequately informed by their doctors about the device’s safety risks.
What is Essure?
Essure is a type of permanent birth control for women where a medical device is inserted into the fallopian tubes to prevent pregnancy. The device is made of two metal coils, one of stainless steel and another of a nickel-titanium alloy. Within the coils are fibers made of polyethylene terephthalate. The coils are designed to keep the device in place within the fallopian tube. The fibers trigger inflammation and result in the formation of scar tissue, which eventually completely blocks the fallopian tubes and prevents the egg from reaching sperm to be fertilized. It can take up to three months for scar tissue to fully block the fallopian tubes, and so women are not supposed to rely on this device for birth control until at least three months after the procedure.
FDA Black Box Warning
In November 2016, the FDA announced that it was requiring Bayer to include a “black box” warning on its Essure label. The FDA reserves black box warnings for the most severe potential side effects of drugs and medical devices. This warning advised consumers that some patients implanted with the Essure device suffered perforation of the uterus and/or fallopian tubes, migration of the device outside the fallopian tubes and into the abdominal or pelvic cavity, persistent pain, and allergic or hypersensitivity reactions.
Essure Risks and Complications
Over the past few years, thousands of women have reported complications after being implanted with the Essure device, including the following:
- Device migrations
- Organ perforation
- Pelvic pain
- Allergic reactions to nickel
- Autoimmune diseases
- Accidental pregnancy
- Heavy menstrual bleeding
Why Choose Meshbesher & Spence?
The attorneys of Meshbesher & Spence continue to provide free case evaluations to Essure victims and their families. If you were implanted with an Essure birth control device, and suffered injury, you may be entitled to compensation for your injuries. Although you can still file an Essure lawsuit, your time could be limited by state law. Therefore, please contact us today for a free consultation and a no-obligation case review of your potential claim.
Bayer – Essure Permanent Birth Control Lawyers