The device is a tool called the power morcellator, which doctors have used in surgery to grind up benign uterine tumors, but not cancerous ones, supposedly. Doing that can cause the cancer to spread. Yet after two decades on the market, regulators realized that many doctors were mistakenly using the tool on women who did have cancer. Backlash against the device was led by Dr. Amy Reed, an anesthesiologist diagnosed with Stage 4 cancer after undergoing what was supposed to be minor surgery to remove her own benign uterine fibroids.
The Wall Street Journal has covered her case and others extensively; in 2014, healthcare company Johnson & Johnson pulled its product from the market. In March, the FBI began investigating Johnson & Johnson to see how much the company knew about the morcellator's hazards before the recall. Last year the FDA warned that women with uterine fibroids have a 1 in 350 risk of carrying cancer, and that most doctors should stop using the device.
For the outspoken Reed and others, that the morcellator stayed on the market for two decades before any regulators took any action is a sign of how broken the FDA's device-approval process is. It's a process, consumer advocates have agued, that gives manufacturers and Big Pharma too much freedom to get a new device approved at the expense of patient safety. Mike Fitzpatrick, a Republican congressman in Pennsylvania, recently took up the cause by proposing an amendment to a healthcare bill that, he said, would improve safety monitoring of medical devices. His inspiration for the amendment came from the power morcellators. "I think it's important to pause and to ensure we do not do more harm than good, given the experiences of thousands of women in just this one scenario," Fitzpatrick said in a Rules Committee hearing earlier this month.
But Fitzpatrick's suggestion was shot down by Texas' Burgess, who was still careful to say that he does not use morcellators. "I did not or do use power morcellators in my practice," Burgess said, before offering a meek defense of the device anyway. Burgess said the problem with the device rested with doctors, who should be taught in medical school not to grind up suspicious tumors. "Every doctor who operates on the abdomen knows that if there is a Stage 1 encapsulated tumor, that disrupting the capsule could make the cancer spread," he said, adding later that "I think it was clinical judgement at fault, not the FDA's approval process."
In fact, the congressman expressed surprisingly warm feelings about the FDA, given his Tea Party affiliations. "My experience is the FDA has been good about recalling those devices when required. You don't think that's what happened in the case of the power morcellator, so be it."
Burgess has a received a few substantial campaign contributions from medical device-makers, including a $5,000 donation from Johnson & Johnson, the leading maker of the morcellator. Dr. Hooman Noorchashm, the husband of Amy Reed, is now asking Burgess in a Change.org petition for a meeting, "to explain to you the depth of your responsibility both as a United States congressman and a gynecologist."