Congressman Mike Fitzpatrick (R-PA) is an outspoken opponent of Bayer’s “permanent” birth control device, Essure. He has made and continues to make efforts on behalf of women seriously injured by this product. His goal, as evidenced in the E-Free Act, which he introduced in November 2014, is to revoke the FDA’s pre-market approval of Essure and remove the product from the market. His latest action on behalf of women’s health took the form of a letter to Department of Veterans Affairs and the Department of Defense. Congressman Fitzpatrick to VA: stop buying Essure!
Congressman Mike Fitzpatrick (R-PA) is an outspoken opponent of Bayer’s “permanent” birth control device, Essure. He has made and continues to make efforts on behalf of women seriously injured by this product. His goal, as evidenced in the E-Free Act, which he introduced in November 2014, is to revoke the FDA’s pre-market approval of Essure and remove the product from the market. His latest action on behalf of women’s health took the form of a letter to Department of Veterans Affairs and the Department of Defense. Congressman Fitzpatrick to VA: stop buying Essure!
The letter was sent to the House Subcommittee on Military Construction, Veterans Affairs and Related Agencies. His message is simple: Essure has caused irreparable harm to tens of thousands of innocent women and the government should not be spending money on it in fiscal year 2017.
His letter says, “We should not allow the Department of Veterans Affairs to purchase and implant this dangerous device in our veterans. We should not be utilizing taxpayer resources to purchase a device that has caused so much harm for so many families.”
I heartily approve of Congressman Fitzpatrick’s message. We, as a nation, must take better care of our Veterans to begin with; they’ve literally put their lives on the line for our freedoms. Implanting them with such a dangerous device, one that has ruined so many lives already would rob them of the enjoyment of the post-service lives they have most definitely earned.
Congressman Fitzpatrick’s letter comes on the heels of a federal district court ruling in Philadelphia allowing five plaintiffs to proceed with suits against Bayer on the grounds the company negligently misrepresented Essure and failed to warn them of the product’s risks. These five suits will move forward despite the pre-market approval (PMA) from the FDA, which usually prevents suits against device manufacturers whose products have PMA status.
In 2008, the U.S. Supreme Court ruled that the PMA-level protections prevented suits in state courts from pre-empting the FDA’s regulatory approval process. However, the SCOTUS ruling does allow suits alleging such devices violated FDA specifications or that are brought under state laws that mirror federal regulations.
U.S. District Judge John R. Padova of the Eastern District Court of Pennsylvania dismissed eight of the plaintiffs’ original claims, but gave them leave to amend their claims of “negligent training, risk management, manufacture, breach of warranty and fraudulent misrepresentation,” according to McEldrew Young, the plaintiffs’ Philadelphia-based co-counsel. Mr. Young added that the case now moves on to the discovery phase.
Bayer was pleased with Judge Padova’s dismissal of the eight claims. However, as more information that becomes available about Essure, one would think that Bayer’s happiness is pre-mature.
The FDA originally reported in September 2014 that it had over 5,000 complaints on record about Essure over a 10-year period. The complaints included: abdominal pain, menstrual irregularities and headaches. Interestingly, after the FDA reviewed its Manufacturer and User Facility Device Experience Database, also known as MAUDE, the number was actually 9,900. Some of the reports detailed things far worse than headaches. There were reports of four adult deaths and the “loss of 294 pregnancies that occurred after” Essure was implanted. An independent study referenced by Congressman Fitzpatrick shows at least 303 fetal deaths.
In February, the FDA recommended that Bayer put a “black box” warning on Essure’s product packaging label. The agency also asked Bayer to create a checklist for doctors to review with patients before Essure implantation. Further, the company also has to create and conduct a post-market study the purpose of which is to help the FDA better understand Essure’s risks.
The last bit is, as my Mother used to say, a bit like “putting the fox in charge of the chicken coop.” Bayer has not been forthcoming with reliable data thus far; nor was its predecessor Conceptus (Essure’s original creator). Why would we think Bayer’s study would be any more reliable now?
For the sake of the brave women who have nobly served our country, I certainly hope that Congressman Fitzpatrick’s letter is taken seriously. After spending months, if not years, away from family, our Veterans don’t deserve to be given a medical device that will rob them of more family time and the enjoyment of their civilian lives.
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