Two Congressmen Turn Up Heat on Power Morcellators

May 01, 2015

Amy Reed, MD, PhD, and her husband, Hooman Noorchashm, MD, PhD, have waged an often lonely campaign to end the use of cancer-dispersing power morcellators in gynecologic procedures and subject all medical devices to tougher safety standards.

Lately, however, the couple has gained some influential supporters in the form of two congressmen from their home state of Pennsylvania as well as America's Health Insurance Plans (AHIP), a trade association. The physicians hope that these allies will nudge Congress to hold hearings on medical-device safety.

Sen. Robert Casey Jr (D-PA) and Rep. Michael Fitzpatrick (R-PA) have recently fired off letters to the US Food and Drug Administration (FDA) questioning how the agency has responded to reports of power morcellators spreading occult uterine cancer during laparoscopic hysterectomy and myomectomy. And in a letter to Casey, the head of AHIP called attention to "serious gaps in the current approval and post monitoring process for medical devices" that have allowed problems with morcellators to escape the notice of regulators for years.

Although the devices have been on the market since 1991, and the problem of dispersed occult cancer had surfaced in the medical literature, the FDA did not receive a report on this adverse event until December 2013, according to Dr Noorchashm. That report detailed how Dr Reed, an anesthesiologist, underwent a laparoscopic hysterectomy 2 months earlier to remove fibroid tumors only to discover that morcellation had spread a previously undetected uterine leiomyosarcoma. The mother of six has since had two cancer operations.

Sen. Robert Casey Jr (D-PA), Rep. Michael Fitzpatrick (R-PA). (Source: Associated Press)

Dr Reed and Dr Noorchashm, a cardiothoracic surgeon, have tried to persuade the FDA to ban these devices that shred tissue for easy removal through laparoscopic incisions, and they likewise have called on gynecologic surgeons to drop this procedure. The FDA has recommended that surgeons stop using the devices for hysterectomy or myomectomy in most women with uterine fibroids and has slapped a boxed warning on the devices saying that they may spread unsuspected cancer. An estimated 1 in 350 women undergoing hysterectomy or myomectomy for fibroid removal have an unsuspected uterine sarcoma, according to the agency.

One manufacturer of morcellators — Johnson & Johnson's Ethicon division — has voluntarily withdrawn its products from the market, and a number of insurers have stopped paying for the procedure or have placed restrictions on it.

This backlash against power morcellators has found its way into the operating room, according to Karen Ignagni, AHIP's president and chief operating officer. "Our chief medical officers report that there has been a major reduction in the use of laparoscopic power morcellators in today's market," Ignagni wrote in her letter to Casey. She attributed the downturn in part to actions by the FDA and health insurers as well as cautionary statements from the American College of Obstetricians and Gynecologists.

So why not go all the way and ban the use of power morcellators outright? Fitzpatrick asked this question in a February 19 letter to then FDA Commissioner Margaret Hamburg, MD. He noted "the avoidable nature of this potentially deadly hazard and unwillingness of industry advocates and many gynecologists to abandon this practice." Power morcellators, he wrote, "may have caused the unnecessary or premature deaths of many hundreds (if not thousands) of American women for over two decades."

Casey's letter of March 2 to Dr Hamburg posed additional questions:

  • When and how did the agency first learn about safety concerns surrounding the devices?

  • What data are the FDA collecting about adverse events?

  • Has the FDA linked adverse events to a particular make of morcellator?

When Medscape Medical News asked the FDA what answers it has given, if any, to the two congressmen, an agency spokesperson said it was "responding directly to Rep. Fitzpatrick and Sen. Casey." Press secretaries for the two congressmen did not respond to repeated requests for an interview.

"Sick People Hurt by This Industry — They Don't Lobby"

Another cause celebre of Dr Reed and Dr Noorchashm, who live in the Philadelphia area, is overhauling the FDA's approval process called 510(k) that has been used to bring power morcellators to market. Under 510(k), a manufacturer need only establish that its product is substantially the same as a device already approved by the agency. Dr Reed and Dr Noorchashm say this expedited process endangers patients because it lacks premarket safety testing and mandatory postmarket monitoring for adverse events. They criticize the FDA for catering to device makers that in their opinion want easy sailing through regulatory waters.

Casey and Fitzpatrick also pressed the FDA on the subject of medical-device safety and the 510(k) approval process in their recent letters. Casey asked what the consequences are for a device manufacturer that fails to report adverse events to the FDA in a timely manner. He also asked how the agency determines whether it should recall a faulty product or let the manufacturer do so voluntarily.

In his letter, Fitzpatrick asked the FDA how it responded to a 2011 report by the Institutes of Medicine that recommended an overhaul of the 510(k) process to ensure patient safety.

Fitzpatrick doubled down on the issue when he addressed FDA officials earlier this month at a workshop on postmarket surveillance of medical devices. The story of Dr Reed, he said, made it clear that "we can do more to catch unsafe devices quickly and prevent further devastation to families."

Dr Reed and Dr Noorchashm also spoke at the workshop. Dr Noorchashm contended that the FDA's Center for Devices and Radiological Health was allowing unsafe devices to reach the marketplace as a result of "mission corruption" — that is, putting the interests of manufacturers at the same level as those of patients. He said that the FDA rarely enforces regulations requiring manufacturers to voluntarily report medical device mishaps.

In her testimony, Dr Reed urged FDA officials to consider the victims of faulty medical devices. "Sick people hurt by this industry — they don't lobby," she said. "They go home and die."

AHIP also wants 510(k) reform.

"We urge discussion around strengthening the 510(k) process and post-marketing assessment of medical devices, including power morcellators," Karen Ignagni said in her recent letter to Casey. "Requiring post-marketing review will greatly improve our ability to identify adverse events and act more rapidly when safety issues are identified.

"Had this been required for morcellators, safety issues would have been identified much sooner."

To spur Congressional action, Dr Noorchashm has been peppering members of both the House and Senate with a steady stream of emails. At this point, he considers Fitzpatrick his strongest supporter. He also would like to win over Rep. Joe Pitts (R-PA), chair of the health subcommittee of the House Energy and Commerce Committee, all for the sake of a congressional hearing.

"If this problem that has happened to my family doesn't trigger a hearing," Dr Noorchashm told Medscape Medical News, "there's something seriously wrong with our Congress."

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