Essure side effects range from ectopic pregnancy to uterine perforation to death. Some women reportedly had a hysterectomy to remove Essure - a permanent sterilization device.
Since Conceptus Inc. (a subsidiary of Bayer Health Care) introduced Essure in 2002, citizen petitions have urged the FDA to order an Essure recall. Besides severe Essure side effects, the petition claims that Conceptus falsified and altered medical records during clinical trials, failed to report adverse events, deceived the public and the FDA about the device’s safety and efficacy, and used defective materials in manufacturing Essure.
Essure was FDA-approved with a list of conditions, one of which was that Bayer report all adverse events. But “troubling long-term data on women” using [Essure], was published on April 24 after an eight-year delay, according to the New York Times (May 2015). Since the FDA fast-tracked Essure to market, 16,047 complaints were filed between 2011 and 2013.
Because Essure has undergone scientific and regulatory review, federal law protects Bayer against liability, giving the manufacturer a “shield of protection” against lawsuits. However, several product liability lawsuits have been filed in the U.S. District Court, Eastern District of Pennsylvania, seeking to remove this shield from Bayer and Essure liability lawsuits. These lawsuits claim that Conceptus violated the conditions of its premarket approval and should no longer receive that protected status.
The first Essure lawsuit, filed in July 2014 in Philadelphia civil court, accused the Essure maker of “intentionally misleading women implanted with Essure and violating the conditions upon which the company received premarket approval” from the FDA. Plaintiff Heather Walsh said that Essure “should never have been marketed or sold,” according to court documents
If the judge agrees with plaintiffs that Bayer committed fraud, it will likely open the floodgates to Essure lawsuits (Case No. 2:14-07315, 2:14-07316, 2:14-07317, 2:14-07318, 2:15-00384, U.S. District Court, Eastern District of Pennsylvania).
What you can do to take Essure off the market
Meanwhile, if you have been injured by Essure, you can help (besides filing an Essure claim with an attorney) take this device off the market.
In a press release (June 2015), Dr. Francois Blaudeau, a practicing obstetrician/gynecologist, asked women and the public who have been injured by Essure to submit their own experiences to an FDA meeting that will be held September 24, 2015.
READ MORE ESSURE LEGAL NEWS
This meeting is crucial to determine Essure’s fate. As well, some women who call themselves “E sisters” are Essure victims who have formed a group with the intention of getting Essure off the market. And even Erin Brockovich, the famous activist, has launched a website urging the FDA to remove Essure from the market.