Bills aim to fix medical-device dangers
WASHINGTON - The medical procedure was supposed to help Amy Reed. Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her.
WASHINGTON - The medical procedure was supposed to help Amy Reed.
Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her.
Reed, an anesthesiologist from Yardley, had a hysterectomy in 2013 to address what doctors thought were benign growths in her uterus. Her doctors used a power morcellator to chop up her uterus. The tissue-slicing device, approved by federal regulators in 1995, enables gynecologic surgery to be done through tiny incisions, reducing blood loss and recovery time.
But the morcellator hurled then-undiagnosed cancer through her body. Reed, 43, has metastatic cancer and is undergoing treatment including experimental immunotherapy.
"Not one person had reported this deadly effect to the FDA" until Reed, a mother of six, experienced it herself, said Rep. Mike Fitzpatrick, a Bucks County Republican.
On Wednesday, he introduced a bill to require doctors to report serious problems with medical devices to the Food and Drug Administration, putting into law a provision that he said already exists in the American Medical Association's code of ethics.
"It should not have been falling to the patients to bring this to the FDA's attention," Fitzpatrick said.
Reed and her husband, cardiac surgeon Hooman Noorchashm, have led a national push to ban morcellators, and to increase oversight of medical devices.
They stood alongside Fitzpatrick at the news conference outside the Capitol with family members and other advocates.
Noorchashm called the proposed legislation "a litmus test" for Congress.
"This is not about politics," he said. "This is about protecting people's lives."
A second proposed bill was sparked by complaints about serious injuries from Essure, the female sterilization coils. It would allow patients to sue medical device makers for problems caused by products, like Essure, that are shielded from liability laws because they underwent a more stringent FDA approval.
Both bills were introduced by Fitzpatrick and Rep. Louise Slaughter (D., N.Y.).
Despite the bipartisan backing, they face long odds. They have no Senate sponsors, and Congress has little work time left this year before lawmakers break for their fall campaigns. Fitzpatrick is not seeking reelection and will leave Congress at the end of the year.
Though the FDA's device regulation has long been criticized as lax, there's no consensus on what to do about it. The medical-device lobby, meanwhile, has significant sway.
"The FDA represents the gold standard when it comes to providing safe and effective medical technologies for patients and providers," said a spokesman for the Medical Device Manufacturers Association. Replacing its expertise "with the lay opinion of a jury is not prudent."
Since Reed and Noorchashm began their push, many insurers have stopped covering the use of morcellators and hospitals have drastically scaled back their use - though some doctors' groups have defended the device's value.
Bayer Healthcare stands by the safety and effectiveness of Essure, though the FDA recently announced plans for a new safety study and tougher label warnings.