Essure is a permanent birth control solution that was designed to give women a less invasive, non-surgical alternative to tubal ligation. Essure was approved by the U.S. Food and Drug Administration in 2002, and while about half a million women have had the device implanted, the FDA has received close to 12,000 adverse reports of injury from the Essure implants.
What are the problems with the Essure birth control system?
What seems to be the most widespread adverse symptom from the Essure implants is severe abdominal pain. In some cases, the sharp metal coils that comprise the implant break apart and tiny shards of metal perforate the fallopian tube, the uterus, and other neighboring organs.
What injuries are women reporting after having the Essure permanent contraception implants?
A few of the debilitating symptoms that some women have complained about include:
Some women who have suffered from these and other symptoms have required surgery to remove the implants. When the implant has come apart, and little bits of it are floating throughout the reproductive organs, a hysterectomy is the only option.
What does the FDA say about Essure?
The FDA has been receiving adverse event reports for injuries and complications from women who have had Essure implants since 2002 when the product hit the market. In 2011, the FDA required Bayer to include a nickel sensitivity warning on the product label. In 2012, Essure product labeling was updated to include the results of a 5-year follow up study and information about pregnancies that have occurred in women using Essure, and another update to the label to include a warning about the risks of chronic pain and device migration. In 2016, the labeling was updated to include a black box warning and a Patient Decision Checklist.
In 2018, the FDA limited the sale and distribution of the Essure birth control implant to those physicians and healthcare providers that review the “Patient-Doctor Discussion Checklist–Acceptance of Risk and Informed Decision Acknowledgement” documents. Both physician and patient are now required to review and sign the documents indicating that they understand the benefits and risks of having the device implanted.
Have there been Essure birth control injury lawsuits filed?
Thousands of women have filed injury claims against Essure manufacturer, Bayer; however, none of these cases have been settled or gone to trial. Women who have suffered injury due to this defective product are claiming that Bayer was negligent in designing a product that is both defective and dangerous and that it failed to adequately warn women of the inherent danger of the product.
If you have been injured by Essure, where can you find help?
A defective medical device attorney can investigate your injury claim and advise you of the legal options available if you want to seek compensation for your injuries and other losses due to Essure.
The defective medical device injury lawyers at McGowan, Hood & Felder, LLC, are compassionate individuals who offer confidential consultations to women who have suffered an injury from the Essure birth control implant. We will review your options after an injury, including filing an individual lawsuit to recover financial compensation if your case meets certain criteria. You are invited to contact our defective medical device attorneys today for a free, no obligation consultation. Discover what we can do for you. Contact us and schedule a free case evaluation. Call 803-327-7800 today.