Proposed Government Bill Aims to Increase Reporting of Defective Medical Devices

Washington, DCIt was two years ago, in 2014 that the US Food and Drug Administration (FDA) issued its safety alert with regard to power morcellators, the medical devices once employed quite frequently for Laparoscopic Uterine Surgery for women. In the face of reports linking use of the device with cancer, the FDA took as its official position, discouragement of use.

The FDA fell short of ordering the devices off the market, even though manufacturers such as Johnson & Johnson voluntarily recalled their devices when reports of Ovarian cancer began to surface. Rather, the nation’s drug and medical device regulator opined that in its’ opinion, the use of power morcellators should be the pathway of last resort. Treatments and procedures for Hysterectomy, Menopause and other conditions should be along more traditional lines - including invasive surgery.

Now, a group of patient advocates led by the husband-and-wife team of Hoorman Noorchashm and Amy Reed - who were the first to file an official complaint over power morcellators with the FDA in 2013 - are lobbying to push the FDA off the fence, and to get the allegedly dangerous devices off the market, altogether.

According to The Cincinnati Enquirer (6/10/16), Noorchashm and Reed - who are also physicians - have teamed up with US Representatives Louise Slaughter (D-NY) and Michal Fitzpatrick (R-PA) for the introduction of The Medical Device Guardians Act of 2016. The legislation, if successful, would allow doctors, surgeons and other health care professionals the capacity to report problems with medical devices to the FDA. They already have that power to report issues with pharmaceuticals, but not medical devices.

According to The Cincinnati Enquirer, only hospitals and device manufacturers have access to the FDA for reporting such concerns. Advocates of the new legislation hold that allowing doctors to report would not only resolve what is widely believed to be a chronic under-reporting of serious complications (and reports of cancer), but would also allow Ovarian cancer patients and prospective plaintiffs more opportunity to litigate in the face of a serious health issue.

Reed underwent a Hysterectomy with a power morcellator, the device that uses minimally-invasive surgery to pulverize fibroids and other tissue within the uterus for removal through a small incision. Such minimally-invasive procedures have been proven to speed healing time and lessen the stress on over-taxed hospital beds.

However, it is alleged that cancerous cells lying dormant or otherwise contained within fibroids, are spread throughout the uterus during Laparoscopic Uterine Surgery for women, triggering Ovarian cancers. When reports of such incidents began surfacing, some hospitals insisted that surgical bags be employed to contain the fragments within the uterus and help minimize, or mitigate the spread of potentially cancerous cells. Other hospitals stopped using the devices altogether for treatment of women’s issues involving Hysterectomy, Menopause of Estrogen.

Ethicon, the unit of Johnson & Johnson responsible for power morcellators manufactured by the pharmaceutical and medical device giant, responded by withdrawing its device from the market altogether in July, 2014 after initially suspending all sales of the device the previous April.

The FDA, for its part, has decided that power morcellators can remain on the market pending further scrutiny, leaving it to doctors and their patients to decide whether to follow the pathway of more invasive surgery without use of power morcellators, or go the route of Laparoscopy and take a chance for spreading cancer.

The FDA continues to recommend Laparoscopic Power Morcellation not be used. But it stops short of mandating the devices off the market altogether.

The proposed legislation gives patients and plaintiffs - and their doctors - more power in the face of the continued availability of power morcellation.

Frank Interlichia was on hand when the proposed bill was announced in early June. His wife died from Ovarian Cancer as the result of treatments for fibroids involving one of the powered devices. Referencing others who had gathered for the announcement, Interlichia noted, “All of us share a similar sad story,” he said amongst two dozen or so patient advocates who travelled to the nation’s capital from as far away as California for the announcement. His late wife’s fervent wish, Interlichia said, was “to make sure this never happens to anyone else.”

Slaughter, in co-sponsoring the proposed bi-partisan legislation, is also asking the Government Accountability Office to investigate why the FDA approved power morcellators in the first place.

“What should been a routine procedure has ended with a death sentence,” Slaughter said.

Fitzpatrick struck a less-dramatic tone: “While we all agree that the majority of medical devices can and should prove to be invaluable, life-saving products,” Fitzpatrick said. “We must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health.”