On Friday, September 23, Representative Mike Fitzpatrick asked Congress for medical device hearing with the goal of updating safety laws governing such devices. Rep. Fitzpatrick (R-PA) asked the Committee on Energy and Commerce to hold hearings examining the negative effects of “unsafe medical devices on patients and the failings of the U.S. Food and Drug Administration.”
On Friday, September 23, Representative Mike Fitzpatrick asked Congress for medical device hearing with the goal of updating safety laws governing such devices. Rep. Fitzpatrick (R-PA) asked the Committee on Energy and Commerce to hold hearings examining the negative effects of “unsafe medical devices on patients and the failings of the U.S. Food and Drug Administration.”
He was not alone in his request, a letter-to-the-committee, by six of his fellow Congress Members: Stephen Lynch (D-MA), Gwen Moore (D-WI), Brenda Lawrence (D-MI), Chris Smith (R-NJ), Ryan Zinke (R-MT) and Louise Slaughter (D-NY). The letter was addressed to the Committee Chair, Fred Upton and the Ranking Member, Frank Pallone.
Rep. Fitzpatrick said, “Many medical devices prove lifesaving, however some devices are having devastating effects on patients, and there must be an effective process in place to track these failures and to quickly remove these devices from the market. Most of our device safety laws were written in the 1970’s. Experts have continued to question the ability of regulators and the outdated laws to identify unsafe devices – and it is putting Americans’ health at risk. It’s time we bring our medical device safety laws into the 21st Century. We must, and we can, maximize innovation and maximize safety.”
The focus of his efforts is not limited to laparoscopic power morcellators and Bayer’s “permanent” birth control device, Essure, but they feature prominently in his mission. The FDA gave its approval for both devices as being safe and both have caused serious harm, including death. Neither device has yet been removed from the market, however.
“The stories of those harmed by medical devices continue to grow. Many have now courageously taken their fight to Congress in an effort to save others from a fate similar to their own. For example, over thirty thousand victims of the Essure device have joined together online sharing stories of how this device caused them serious injury. These women continue to fight the FDA to protect the health of future women.
Moreover, hundreds, if not thousands, of women have been killed or seriously injured by the laparoscopic power morcellator device. It took victims of morcellation, the ones in the worst position to act, to get the FDA to finally take notice. In the 21st century, it should not take a victim to raise the issue of the unsafe consequences of these devices to the attention of regulators.”
The E-Sisters have made repeated trips to our nation’s capital calling on our lawmakers for assistance in their fight. There are also pending legal actions. In fact, three days from now (September 29), the Judicial Panel on Multidistrict Litigation (JPML) will hold a hearing to determine if those legal actions against Bayer will be consolidated for pre-trial purposes in a multi-district litigation (MDL).
Rep. Fitzpatrick and his fellow lawmakers also point to a Johns Hopkins Medicine study, which states that “medical errors are the third leading cause of death in the United States, equating to 10 percent of all annual deaths.” One finds that figure frightening and unacceptable.
It’s time, as Rep. Fitzpatrick and colleagues assert, to bring our medical device safety laws into the 21st century. It is also time in this writer’s opinion, to put an end to the greed-based paradigm of “Profits over Patients” that has caused so much suffering and death.
Join the conversation!