Withdrawal of Product Precedes Critical Documentary
Citing poor sales, as well as “inaccurate and misleading publicity” regarding its non-surgical permanent birth control device marketed under the name Essure, Bayer has announced that it will stop selling the product at the end of the year. The decision comes on the heels of an order from the U.S. Food and Drug Administration (FDA), issued in April, which significantly restricted sales of the device. The announcement also anticipates The Bleeding Edge, a documentary from Netflix that chronicles the side effects that have been reported by users of the Essure product.
At Bailey & Galyen, we have extensive experience protecting the rights of individuals who have suffered injury because of the poor design, manufacture or malfunction of a medical device. To schedule a free initial consultation to discuss a potential claim for damages caused by the Essure device, contact our office online or call us at 844-402-2992.
The Essure device, the only non-surgical contraception device currently on the market, involved the insertion of a metal coil into each fallopian tube, causing scar tissue to develop. The scar tissue creates a blockage, which is intended to prevent conception. The product was developed by Conceptus Inc. and received FDA approval in late 2002. While a 2009 review of the device found that it appeared to be effective, critics have alleged that the study was based on short-term studies only. Over the last five years, increasing controversy has centered on the device, with thousands of users claiming serious side effects, and many undergoing surgical extraction.
As of July 2018, more than 16,000 lawsuits have been filed, alleging a wide range of health problems, including fallopian tube perforation, serious pain and bleeding (some requiring hysterectomies) and even some deaths. While the company originally reported a failure rate of less than 1 percent, there have been hundreds of claims of unintended pregnancies in the past couple years. The device has also been linked to:
- Nausea and vomiting
- Allergic reactions
- Autoimmune disease-like symptoms
- Back and joint pain
- Numbness and tingling in extremities
- Anxiety and depression, including thoughts of suicide
- Weight gain
- Hair loss
An FDA news release issued April 9, 2018, referenced the reports of pain and perforation and also expressed concerns that the coils could migrate from the fallopian tube to the pelvis or abdomen. FDA Commissioner Scott Gottlieb, M.D., stated, “We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option.” Gottlieb further stated:
- We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.
The April order mandated that Bayer take additional steps to “provide reasonable assurance of the device’s safety and effectiveness.”
In all public statements surrounding the withdrawal decision, Bayer has insisted that liability issues and potential health risks tied to the product have not been a factor. A spokesperson said the “voluntary discontinuation” was “not indicative of safety issues,” and Bayer emphasized that it “stands behind the product’s safety.” However, the FDA says that, as of early 2018, more than 26,000 complaints have been logged with the agency related to the product, and that Bayer had another 11,000 complaints that it received directly.
Contact the Experienced Criminal Defense Attorneys at Bailey & Galyen
At the law office of Bailey & Galyen, we provide a free initial consultation to anyone with a potential Essure-based injury claim. To set up an appointment with an experienced Texas personal injury attorney, contact us by e-mail or call our offices at one of the convenient locations listed below. We will take your call 24 hours a day, seven days a week.