Essure Contraceptive Device Sales Halted by Bayer, FDA Cites Product Dangers
The pharmaceutical giant Bayer has announced it will cease Essure sales in the United States by 2019. The brand-specific contraceptive device has been controversial for years due to its apparent dangers, and Bayer’s refusal to accept any liability for them. Many women who have used Essure have suffered significant side effects and health complications like crippling pain, hair loss, and internal organ perforation.
Essure is a two-inch metal coil, comprised primarily of a nickel-titanium alloy, which is inserted non-surgically into a woman’s Fallopian tubes. In a few months, the device agitates the Fallopian tubes enough to cause scarring. The resulting scar tissue blocks conception, acting as a permanent form of birth control.
However, Essure has not proven safe for all users. If the metal device migrates out of place, it can cause perforation of the Fallopian tubes that requires surgery to correct, among other dangerous health conditions.
Essure Restrictions & Reviews from the FDA
Before Essure hit pharmaceutical markets, it actually gained an approval from the Food and Drug Administration (FDA). Upon learning of its dangers, people far and wide took to social media and various other outlets to express their concern and disdain to the FDA. The Administration ultimately decided to reanalyze Essure for safety. During the second wave of reviews, the FDA determined that most patients who used Essure had never been given a full disclosure of its potential side effects.
In order to try to correct the situation and protect future users from serious harm, in 2016, the FDA demanded that Bayer put a “black box” label on Essure’s packaging and provide doctors a checklist of potential complications to discuss with every patient. Only a few months ago, the FDA exercised its power to restrict the sale of Essure. The FDA has long held the ability to limit pharmaceutical device sales, but it has rarely been used throughout its history.
(You can view a press release from the FDA regarding Essure, its potential dangers, and its halted sales by clicking here.)
Bayer Deflects Liability for Essure’s Dangers
When the announcement from Bayer stated Essure would be discontinued in the United States, product safety groups and medical safety organizations assumed the company would admit the contraceptive was too dangerous for sale. However, Bayer remained insistent that Essure is and always has been safe for widespread use. To explain its reasoning behind Essure’s discontinuation, Bayer pointed at low sales numbers, claiming it was no longer fiscally viable to continue the product.
Our Pittsburgh defective medical device attorneys of Robert Peirce & Associates, P.C. are here to help people fight for fair compensation from Bayer after using Essure and suffering severe injuries. The company might be steadfast in saying the contraceptive is safe, but we are all the more tenacious in our pursuit of justice for our clients. We have been the trusted name in injury representation throughout Pennsylvania for nearly 40 years, and we have secured multiple multi-million dollar case results for our clients.
Would you like to learn how to start your Essure claim or lawsuit? Call (844) 383-0565 or contact our firm onlineto schedule a free consultation.