|Ethicon's Morcellex Sigma Tissue Morcellator--Courtesy of Johnson & Johnson|
The FDA has faced its fair share of scrutiny over power morcellators, with the public and advocacy groups claiming that the agency took a backseat in regulating the devices. Now Congress is weighing in on the issue, urging the federal government to investigate the FDA's approval process and monitoring of the tools.
As The Wall Street Journal reports, a bipartisan group of 12 lawmakers including Rep. Mike Fitzpatrick (R-PA) and Rep. Louise Slaughter (D-NY) sent a letter to the U.S. Government Accountability Office (GAO) asking the agency to look into the FDA's track record on morcellators. Regulators have cleared at least 10 power morcellator devices for sale since the first one hit the market 24 years ago. And even though the FDA cautioned about morcellators' risk of spreading undetected cancers after the issue surfaced in late 2013, its warning "came decades after some studies were already pointing to a serious problem," the letter states, as quoted by the WSJ.
"(T)he FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000," the letter states, as seen by the WSJ. "How did they get it wrong for so long?"
Last year, the FDA issued a warning against using laparoscopic power morcellator tools in minimally invasive surgeries to remove uterine fibroids. The agency said that women undergoing the procedures had a 1 in 350 risk of uterine sarcoma and that morcellator tools could exacerbate the spread of cancerous cells. Before regulators issued their warning, the device was used in about 50,000 U.S. uterine surgeries each year.
The agency's warning triggered public and industry backlash, with Johnson & Johnson ($JNJ)--the world's largest maker of the devices--pulling its product from the global market in July 2014. In November, the FDA ramped up its oversight of power morcellator products, recommending against using the devices in the "majority" of women undergoing a hysterectomy or uterine fibroid removal. The agency also called for boxed warnings and two contraindications for power morcellators in their product labels.
Still, some argue that the FDA's oversight of power morcellators points to a bigger problem, as the agency's lenient clearance system allows too many risky devices to hit the market. But the FDA is defending the process, saying that 510(k) clearance allows regulators to balance "innovation and safety," Dr. William Maisel, the agency's chief scientist, told the WSJ last year.
- read the WSJ story (sub. req.)