Women’s Cancer Risk Raises Doubts About FDA Oversight

Jon Kamp, Wall Street Journal, appeared on Fox News

July 8, 2014

A U.S. Food and Drug Administration database that catalogs medical-device problems holds thousands of entries on a tool called a laparoscopic power morcellator, used since the 1990s.

But before December, none of those reports linked the tool to a potentially deadly risk: worsening a rare and often-hidden uterine cancer. Instead, older entries documented malfunctions and occasional injuries to patients.

Medical studies and literature had highlighted the risk since the tool made its debut. But the FDA didn’t begin to closely examine the danger until late last year, when a Boston doctor took her case public in The Wall Street Journal.

As the FDA prepares to hold hearings this week in Maryland on the future of the device, critics say the power morcellator case demonstrates weaknesses in the surveillance network for medical tools after they hit the market. An agency panel will hear testimony Thursday and Friday.

Morcellators use tubular blades to slice up common and generally benign uterine growths called fibroids so they can be removed through small incisions in minimally invasive procedures. In April, the FDA discouraged these procedures while estimating one in 350 patients could have a concealed cancer that the devices may spread.

Through medical records and interviews with doctors, the Journal has identified at least two dozen cases before December where morcellators likely worsened cancer. Medical journal articles and researchers have also identified numerous cases since the devices were introduced.

“Why is it that even when we know numerous women have already had this happen to them, it’s not in the database?” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit organization that advocates for product safety.

The FDA approves nearly all devices, including morcellators, through a process that typically allows products deemed substantially similar to something already marketed to be sold without clinical-trial data. The FDA has said it is unlikely a more intense review would have highlighted the morcellator’s cancer risk sooner, but this approval process in general requires close post-approval monitoring, experts said.

The FDA in recent years developed a blueprint for significant surveillance improvements. But for now, the agency’s principal tool remains a system that gathers reports on problems in a huge database called Maude, which can be mined to find or analyze these problems, said Rita Redberg, a cardiologist at the University of California San Francisco Medical Center who is critical of FDA surveillance efforts.

The agency requires hospitals and device makers to chronicle cases linking devices to deaths and serious injuries. Doctors don’t have to report issues, although they are encouraged to and can even do so by smartphone.

The FDA said it long knew morcellators could spread uterine cancer, but the fresh attention prompted new analysis that found a higher-than-realized cancer risk. The agency said it didn’t know why it didn’t receive reports of morcellator-worsened cancer before December but noted doctors would have to connect advanced cancer cases to an earlier procedure.

Magdy Milad, chief of gynecology and gynecologic surgery at Northwestern Memorial Hospital in Chicago, agreed. He wrote a recent paper citing underreporting of complications linked to morcellators but said it is a particularly daunting problem to catch.

There were times connections were made but not reported. Boston’s Brigham and Women’s Hospital confirmed two instances where morcellation worsened cancer, including the case that sparked public debate last year. While the hospital regularly files device reports, risk managers there didn’t think this was a reportable issue, a spokeswoman said.

“The devastating outcome was the result of the undetected cancer, not device malfunction or failure,” she said.

Regulatory experts said the hospital should have reported the cases. But they also said lax enforcement gives hospitals and doctors little incentive to call out mishaps.

The FDA said it found that encouraging more and better reports from hospitals and doctors, rather than levying sanctions, is the best use of limited resources. The agency said it focuses more on enforcement with medical-device companies.

The lack of earlier morcellator alarms worries Jim Leary, a Greece, N.Y., police officer whose wife, Barbara, died in September. She was diagnosed with uterine cancer in early 2009 after a doctor at Rochester General Hospital used a morcellator to remove what looked like a benign fibroid, according to the patient’s records.

A month after she died at age 52, the same doctor at the same hospital performed a similar procedure on another woman who is now battling advanced cancer, according to the patient’s records. The hospital and doctor have declined to discuss these cases.

More than 20 reports linking morcellation and cancer have filtered into Maude since December. Some came from patients, others from doctors, including the husband of the Boston patient who raised alarms, and several came from Johnson & Johnson, the largest manufacturer of the device. They were triggered by lawsuits and news stories, a J&J spokesman said.

J&J halted global morcellator sales after the FDA’s April advisory, though it has defended the devices’ safety.

The FDA’s planned surveillance improvements include rolling out device codes over the next several years that could link to patient records. Other steps include planned improvements to the adverse-event reporting system and analysis tools.

But these reforms are coming slowly, said Michael Carome, director of the health research group at consumer advocate Public Citizen.

“The FDA has known for decades that their post-market surveillance methods for devices are inadequate,” he said. “They have been very sluggish.”