As this was being written, Reps. Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) were introducing a package of bills aimed at fixing the FDA’s flawed medical device approval process. WRIC.com 8News in Richmond, Virginia reports the recent release of a study that shows this proposed legislation is crucial to patient safety, especially in the area of women’s health. The study shows FDA used flawed data to approve devices, including Essure.
Health & Medicine
On Wednesday, June 8, Representative Mike Fitzpatrick announcing medical device and FDA reform bills. The Congressman from Pennsylvania has been a consistent supporter of women’s health issues, especially as pertains to dangerous medical devices. Once again, Rep. Fitzpatrick (R-PA) is headed to DC to fight, not only for those injured women, but for reforming the FDA’s medical device approval process.
On May 20, Big Pharma/Life Sciences giant Bayer filed a motion in federal court in the Eastern District of Missouri. Its goal? Removal of a pending suit filed in state court in St. Louis over its “permanent” birth control device, Essure. Six days later, Judge Carol E. Jackson of the Eastern District of Missouri handed down her decision on the removal request. Bayer lost bid to remove Essure suit to federal court. The judge, in effect, said that the suit was perfectly situated in the state court.
Bayer, owner of the “permanent” birth control device Essure, knew of the risk of unwanted pregnancies after implantation of its device. That the Big Pharma giant knew is not shocking; that someone was able to uncover the information is the shocker. As many of us who advocate for the removal of this dangerous product have long believed, Bayer lied about Essure pregnancy risks.
Women injured by pelvic mesh implants have found a new way to fight back. This is the shot heard ‘round the world, mesh community hits social media! The Mesh Awareness Movement (MAM) currently hosts parties every Friday night on Twitter, as well as keeping an active Facebook page.
The most touching thing one can do is to put a human face on what Bayer and the FDA see as statistics only. Guess what, folks? Brianne has gone and done such an amazing job of it that I had to share. Thank you, Brianne! Here is “Dear Bayer – Do you care? A letter about Essure and doing the right thing.”
A recent letter to Congressman Jason Chaffetz, written by Holly Ennis of Ennis Law and various administrators of Essure Problems, contains an Essure investigation and congressional hearing request. The request is backed by a great deal of sound reasoning and good evidence. It is a long piece, compared to our usual stories on LegalReader, but it is an important piece and, therefore, is reproduced in its entirety below.
There have been some unique and inexplicable changes in adverse event reporting regarding Bayer’s “permanent” birth control device, Essure. The changes began July 17, 2015 after the agency announced its review of Essure’s safety and efficacy. In a recent letter, Congressman Mike Fitzpatrick questions FDA about Essure reporting changes.
Those who suffer from chronic heartburn may have to add an additional heartburn concern to their list. Chronic heartburn drug use linked to kidney disease risk, according to a recently published study in the Journal of the American Society of Nephrology.
Boston Scientific is finally facing greater heat over allegations that it used substandard material in its vaginal mesh implants. Federal prosecutors have impaneled a grand jury in Charleston, West Virginia as Boston Scientific faces criminal investigation over counterfeit mesh. It’s about time! The affected mesh has been implanted into thousands of women across the U.S.