Why is there an Essure Implant Recall?

The Essure permanent birth control device, sold by Bayer, has been used by over 750,000 people since it became available in the United States in 2002. It was taken off of the market in 2018, allegedly due to the 70% drop in sales experienced after the US Food and Drug Administration (FDA) required a post-market study and addition of a black box warning, meaning the drug can have serious and sometimes life-threatening side effects.

What is the Essure implant?

The implant is the first-ever sterilization option for women performed without an incision or general anesthesia, an alternative to having your “tubes tied.” In contrast to intrauterine devices (IUDs) which are implanted in the uterus and are replaced after a few years, Essure is implanted in the fallopian tubes, and was not made to be removed.

The FDA approved Essure after a fast-tracked review process, prioritizing approval of the device due to its novelty. However, it is apparent that more testing was needed to safely release the product to the market. The recall necessitated the removal of the implant, but due to the small amount of research done on the product, many doctors do not know how to remove Essure without surgery, and the best method of removal is not entirely clear.

What lead to the Essure lawsuit?

Between Essure’s release to market in 2002 and 2017, the FDA received about 30,000 adverse event reports describing difficulties with the product. Since, approximately 32,000 patients have filed lawsuits stating a range of issues caused by Essure from abdominal pain and unintended pregnancies to perforation of the uterus and even several deaths, including a few infants.

These cases state the issues stem from the lack of solid data on the implant’s safety and the fact that Bayer chose not to report any injuries from Essure they were aware of to the FDA. Complications have also occurred due to Bayer not giving doctors proper training on implantation. The initial clinical trials did not have reliable conclusions, as they did not include any control groups to use as a comparison, like women sterilized surgically or those using other birth control. In contrast, all drug trials are required to have a control group who are given a placebo.

Another problem is that the true number of individuals who experienced complications with Essure is not clear, since Bayer refused to provide US sales numbers. Available numbers in the US do not reflect the real numbers since it can’t be known how many of the products were actually implanted.

The experienced attorneys at Kwartler Manus, LLC. can help you

Lawsuits are being filed for both negligence and injuries caused. If you or a loved one have experienced any complications due to receiving an Essure device, contact us at Kwartler Manus LLC to find out how you can receive justice. There are lawsuits against Bayer for a wide range of injuries caused by Essure, including:

  • Hysterectomy
  • Ectopic pregnancies
  • Unintended pregnancies
  • Breakage of inserts
  • Migration of inserts
  • Nickel poisoning
  • Severe menstrual pain
  • Autoimmune disorders
  • Severe abdominal or pelvic pain
  • Heavy Menstrual bleeding
  • Perforation of the uterus, fallopian tubes, and/or other organs

Bayer announced it would stop selling Essure in 2018, but the company still denies any wrongdoing. There are not currently any class action claims, but individuals can file an individual Essure lawsuit to receive the compensation they deserve. At Kwartler Manus, LLC, our attorneys are dedicated to assisting those harmed by the usage of an Essure implant and have over 40 years of combined experience in personal injury litigation. Contact us online or call our office at (267) 457-5570 to schedule a consultation.

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