Birmingham, ALDespite the FDA having received more than 5,000 adverse event reports regarding Essure, the birth control device is still on the market. Now hundreds of Essure victims are taking action to ensure that Essure is taken off the market.
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.
Essure lawsuits
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.
(The FDA meeting is an opportunity for anyone to provide advice and recommendations to the Agency on FDA’s regulatory issue. An advisory committee at the meeting will discuss the risks and benefits of Essure for permanent female sterilization. After evaluating data regarding adverse events, the committee will provide recommendations regarding appropriate device use, product labeling, and potential need for additional postmarket clinical studies. The public will have all background information and data from the FDA no later than two days before the meeting.)
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.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a defective products lawyer who may evaluate your Essure claim at no cost or obligation.