As of June 20th of this year, the Food and Drug Administration (FDA) had received 29,430 complaints about Essure, a permanent birth control device manufactured by Bayer, the pharmaceutical giant. The adverse effects associated with the product include perforation, pelvic pain, bleeding, depression, and autoimmune conditions.
The device was discontinued by Bayer just ahead of the release of a Netflix documentary called “The Bleeding Edge,” which exposes the health effects of products like Essure. Bayer claims there is no connection. Essure is the only FDA-approved non-incisional form of permanent birth control.
“The Bleeding Edge” is described as “a look at the unforeseen consequences of advanced technological devices used in the medical field.” This Netflix documentary explores the $400 billion medical device industry, and it delves into five of the products that have wreaked havoc on thousands of people’s lives.
In addition to the Essure device, the film looks at hip implants, robotic surgeons, and more.
What is Essure?
Essure is a flexible metal coil with polyester fibers. Doctors insert it through the vagina into each fallopian tube. It prevents pregnancy by causing scar tissue to build up in the tubes. It is the only device of its kind.
According to Bayer, the voluntary recall is due to declining sales that make the product unsustainable, not product liability matters. The company continues to stand behind the product, claiming that its benefits, safety, and efficacy are validated by a substantial body of research by both Bayer and independent researchers.
The research evaluated over 200,000 women throughout a twenty-plus-years period. They have further stated that women who already have the device implanted can continue to confidently rely on the device.
However, according to the women suffering what are described as sometimes severe side effects, as well as other critics, the device should have been recalled years ago. According to Bayer’s annual report, more than 16,000 women have filed lawsuits, and the FDA restricted the sale of Essure to medical facilities this year.
Additionally, doctors were required to use a specific checklist to inform patients of the many potential side effects of the product. In 2016, the FDA mandated that Bayer add a black box warning to the label, and required the company to continue surveillance of the product’s safety and effectiveness.
Bayer blames “misleading and inaccurate publicity” for the 70-percent drop in sales. A Bayer spokesperson claimed that the benefit-risk profile for Essure has not changed.
A benefit risk profile is developed by determining whether the benefits of a product outweigh the risks. However, new information on an increased risk can change the profile. When that happens, the FDA is required to impose rules for the product, which was done in the case of Essure.
Atlantic City Product Liability Lawyers at D’Amato Law Firm Fight for Your Rights and Your Safety
The women who have suffered the side effects caused by Essure may be entitled to financial compensation in the form of punitive damages. This may include medical bills, lost wages, pain and suffering, and other damages. If you have suffered an injury or an illness because of a defective product, or if a loved one has died, the Atlantic City product liability lawyers at the D’Amato Law Firm will fight hard to win the financial compensation you deserve. Please call 609-926-3300 or contact us online for a free consultation. We help clients throughout New Jersey.