A family tragedy has driven two physicians into a pitched battle with the Food and Drug Administration over the use of power morcellators in gynecologic procedures. The battle, closely watched by defective medical device attorneys at Eisbrouch Marsh, is over the use of the instruments, which are used to shred fibroid tissue for easy removal through laparoscopic incisions, typically in laparoscopic hysterectomy and myomectomy.
The two physicians, Dr. Amy Reed, an anesthesiologist and mother of six, and her husband, Dr. Hooman Noorchashm, a cardiothoracic surgeon, have a deeply personal stake in the outcome because of a laparoscopic hysterectomy that Dr. Reed had in October 2013 to remove fibroid tumors. In that procedure, a power morcellator shred the tissue for removal only to find that a previously undetected uterine leiomyosarcoma had been dispersed by the procedure. Since that procedure and the discovery of the undetected sarcoma, Dr. Reed has had to undergo two additional cancer surgeries.
Morcellation and uterine cancer dangers
Although power morcellators have been in use since 1991, the adverse event report filed by Dr. Noorchashm after his wife’s failed procedure was the first received by the FDA. The husband and wife team have since been calling on any powerful political and medical influencers who could help in their quest to have power morcellators banned by the FDA.
Their battle was recently joined by two Pennsylvania congressmen, Sen. Robert Casey Jr. (D-PA) and Rep. Michael Fitzpatrick (R-PA) and the powerful trade association, America’s Health Insurance Plans (AHIP). Both congressmen have sent letters to the FDA to hold their feet to the fire on the question of how the FDA has responded to reports of power morcellators spreading occult uterine cancer during gynecological procedures.
FDA responds to undetected cancer risks
Not only has the FDA issued a recommendation that gynecologic surgeons drop the morcellation procedure, they’ve mandated a boxed warning on the power morcellation devices describing the risk of the procedure spreading an undetected cancer. An estimated 1 in every 350 women who undergo a laparoscopic hysterectomy or myectomy to remove fibroid tumors has an unsuspected uterine sarcoma.
Johnson & Johnson has pulled its power morcellator devices from the market while several insurers have stopped paying for the procedures.
510 (k) device clearance program under fire
Drs. Reed and Noorchashm are also determined to see the FDA overhaul its 510(k) program for bringing new medical devices to the market. The program allows a medical device such as a power morcellator to bypass the regulatory process if the manufacturer can establish that the device is similar to another device already approved by the FDA.
Defective medical device attorneys have railed against this process because it lacks safety testing prior to going to market and does not mandate any post-market monitoring of adverse events. At a workshop on postmarket surveillance of medical devices, Rep. Fitzpatrick confronted FDA officials on the laxity of the 510(k) process saying that Dr. Reed’s story confirms that “we can do more to catch unsafe devices quickly and prevent further devastation to families.”
At the same workshop, Dr. Reed herself faced down the FDA officials and urged them to think of the victims of dangerous medical devices. She said, “Sick people hurt by this industry—they don’t lobby. They go home and die.”
Consult with experienced power morcellator lawyers
Eisbrouch Marsh offers skilled legal advice for anyone who has been harmed by a defective medical device in New Jersey or New York. Call 201-342-5545 to schedule a free case review to learn more about your options for pursuing a power morcellator lawsuit.
- Medscape, Aetna Won’t pay for Most Fibroid Removal Using Morcellators http://www.medscape.com/viewarticle/844253
- Drugwatch.com, Device Maker Threatens Husband who Launched Anti-Morcellation campaign http://www.drugwatch.com/2014/09/02/karl-storz-threatens-morcellation-campaign/
- Philly.com, Doctor Fighting to Ban Morcellators Has Cancer Recurrence http://articles.philly.com/2015-03-06/news/59812769_1_morcellation-hysterectomy-cancer-recurrence