Morcellation: GAO confirms concerns about surgery

• A federal watchdog says the FDA knew power morcellators could spread tissue.
• Widower said the report should have included the family's side of the story.

A federal agency knew for years that a type of surgical device implicated in the deaths of at least three Rochester-area women had the potential to cause a problem but thought the risk was low.

The Food and Drug Administration didn’t take a closer look at power morcellators until families began asking questions about the outcomes of some minimally invasive gynecologic surgeries that used the devices.

Even though their concerns have been documented by a congressional watchdog, one husband said the report that the Government Accountability Office released Wednesday still isn’t enough.

“In this report, did they talk to one victim or one victim’s family?” asked Jim Leary of Greece. His wife, Barbara, had surgery for presumed fibroids in 2009 and died in 2013. “It’s slighted in it’s all positive and doesn’t talk or show the victims and their side. That’s what’s very disappointing. I don’t think it was a complete or thorough investigation.”

Power morcellators cut tissue into tiny pieces that can be easily removed through small incisions and were used in surgery to remove uterine fibroids. The action of the blades can spread tissue within the body. But there is no way to know whether a benign fibroid harbors cancer cells that are scattered by the morcellator.

Between 2009 and 2013, Barbara Leary, Brenda Leuzzi and Linda Interlichia underwent minimally invasive surgery for fibroids in procedures that used power morcellators. Pathology reports later determined the fibroids harbored undetected cancer cells. Linda Interlichia and Brenda Leuzzi died in 2014.

The issue became public late in 2013, after the wife of a cardiothoracic surgeon underwent the procedure in a hospital in Boston. Dr. Hooman Noorchashm began a social and traditional media campaign.

The academically written report goes into great detail about what the FDA, manufacturers and doctors and hospitals knew about power morcellators and did or did not do to report problems. It points out that the FDA didn’t aggressively pursue reports from the 1980s that power morcellators could spread tissue, and it reviewed how the FDA approved the devices and requirements for doctors, hospitals and manufacturers to report adverse events.

An exact number of women who were harmed or died by use of a power morcellator is almost impossible to figure out. Noorchashm said the number is likely in the thousands, based on self-reports to his petition on change.org and estimates by the FDA and in the GAO report that the rate of uterine sarcoma is about 1 in 350 and the risk of leiomyosarcoma is about 1 in 500 for women undergoing surgery to treat fibroids.

Leary, who read Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling before it was released, said it failed to ask tough questions of the agency, the device makers and their users. He said that may be because of pending lawsuits by families.

The report was commissioned in 2015 by members of Congress, including Rep. Louise Slaughter, D-Fairport. GAO conducted its research from February 2016 to this month.

Leary said that because the 44-page report lacks the family’s point of view, it is likely to end up on a shelf.

“I don’t see the average person bothering to read this,” he said. “There has to be something earth-shattering to grab the public’s attention, and it just goes on and on. … Any one of our stories would have been the grabby moment, would have gotten people’s attention.”

The report has comments from professional organizations about what the FDA should tell patients about morcellation, but appeared to not ask a patient group.

The GAO has no enforcement power, and any changes in procedures would have to originate from the president through executive order or through Congress.

In a news release, Slaughter said the report “shed light on a broken system” and that “immediate congressional action is needed to reform the process and save lives.”

She also said that power morcellators no longer are appropriate to treat fibroids.

Rochester General and Strong Memorial, where the three known power morcellator procedures took place, were among the first hospitals in the country to stop using the devices in the spring of 2014, after the FDA issued a safety recommendation. Both hospitals were inspected by the FDA for their practices in reporting on medical devices.

"We support efforts to assess the FDA device reporting system and identify ways to improve it for patient safety," wrote Barbara Ficarra, associate director of public relations and communications at the University of Rochester Medical Center.

A request for comment from Rochester Regional Health was not immediately returned.

The FDA has not banned power morcellators, but they must have a warning label.

Frank Interlichia said the report keeps the issue before the public.

"The report demonstrates that there are serious problems not only with with the approval process for medical devices — but also the fact that legal reporting requirements for physicians, manufacturers and hospitals has been completely lacking," he wrote in an email. "The FDA, while having made some improvements after patients brought issues to light in late 2013, was terribly slow to recognize the danger to women.

"My hope for the future is that this report will help spur action from Congress and especially from professional medical societies, hospitals and physicians to improve safety for patients."

Noorchashm has taken the FDA, manufacturers and the field of gynecology to task for more than three years.

“If I were GAO I would make this more emphatic, that something seriously wrong happened here,” said the surgeon, who now lives near Philadelphia. “The reality is that literally thousands of women, unsuspecting, have been harmed or died because of this.”

Still, he said the report was significant because it came from a government watchdog that reached the same conclusion that he had used to galvanize families.

“Now it’s no longer, for lack of a better term, victims frothing at the mouth,” Noorchashm said.

PSINGER@Gannett.com