2017-02-09 10:04:13
Weak Reporting System Let Risky Surgical Device Stay in Use

Doctors and hospitals failed to tell the Food and Drug Administration about cases in which cancer was spread around inside women’s bodies by a surgical tool used to operate on the uterus, according to a report issued on Wednesday by the Government Accountability Office.

Scattering cancer cells worsens the disease and decreases a patient’s chances of long-term survival.

Because information was lacking, the tool, called a power morcellator, was widely used for more than 20 years before the F.D.A. acted to limit it, after being alerted to the problem in 2013 by a patient who was harmed. The device, with a spinning blade that shreds tissue, was by then being used in at least 50,000 women a year in the United States to help remove benign uterine tumors called fibroids, or to remove the entire uterus. It had become a mainstay in minimally invasive surgery, slicing up tissue so it could be removed through tiny incisions.

But some women with fibroids have undiagnosed cancers, and morcellation can spray malignant cells around inside the abdomen and pelvis like seeds, “upstaging” the disease to a more advanced and deadly form.

Before 2013, the F.D.A. had received no reports of uterine cancers being disseminated by morcellators. But after the 2013 case, which was widely covered by the news media, reports began to pour in, and by September 2016 there were 285. Some of the women have died.

The government report points out a major flaw in the system for detecting harm from drugs and devices like morcellators: It is passive, relying on “adverse event” reports to the F.D.A. from doctors, hospitals, drug and equipment manufacturers, and consumers.

But doctors and hospital officials told investigators with the accountability office that before November 2014, when the F.D.A. explicitly stated that cancer spread after morcellation was an adverse event that had to be reported, they would not have regarded it that way or reported it. Previously, they had thought adverse events from surgical tools were related mainly to failures of the device itself. And in the cancer cases, the morcellators were doing exactly what they were supposed to do — slicing up tissue.

“The passive reporting of adverse events is a weak system,” Marcia Crosse, the director for health care at the accountability office, said in an interview.

In a written statement, the food and drug agency said that it agreed with the report’s findings and that “the F.D.A. has noted the shortcomings of the current passive postmarket surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice.”

But the findings have landed just as the Trump administration has suggested that drug and device regulations should be loosened, not tightened.

Dr. Crosse said one remedy might be for the F.D.A. to take a more active role in finding cases, by reviewing hospital records for problems that should have been reported but were not, and by mining huge amounts of data for rare conditions that may be warning signs.

“But those things are expensive,” she said. “They require data systems that are not currently in place. And it’s not clear how much faster or how many more problems would be turned up. But right now they are in the position of having to wait for these things to be filed.”

Morcellators are still available, but their use in fibroid surgery has fallen considerably. In November 2014 the F.D.A. said the devices should no longer be used in “the vast majority” of women having fibroid surgery.

Morcellators came onto the market in 1991 via an F.D.A. process known as 510(k), in which devices are cleared for use without going through the usual lengthy approval process, because they are similar to devices that have already been approved. The morcellators for uterine surgery were cleared because the F.D.A. considered them similar to tools used in minimally invasive knee operations and other orthopedic surgery — even though the orthopedic equipment had not been used inside the abdomen or pelvis, or for cancer.

The F.D.A. knew when it first allowed morcellators for uterine surgery that there was a chance the devices could spew hidden tumors around. But the risk was thought to be small, with one in 500 to one in 10,000 women who had fibroids also having undetected cancer. Subsequent research found the risk was greater, about one in 350.

The problem came to light in 2013 when Dr. Amy Reed, then 40, an anesthesiologist and the mother of six children, had her uterus removed because of fibroids at Brigham and Women’s Hospital in Boston. A biopsy after the operation found a hidden sarcoma, an aggressive type of cancer. Morcellation had spread the tumor, transforming it to advanced, Stage 4 cancer.

Dr. Reed and her husband, Dr. Hooman Noorchashm (pronounced NOOR-chash), a cardiothoracic surgeon, have been campaigning ever since to stop morcellation, hoping to spare other women from what happened to Dr. Reed. Dr. Noorchashm said the accountability office report resulted from his appeals to former Representative Mike Fitzpatrick of Pennsylvania, who teamed up with a group of colleagues to ask for an investigation.

Since 2013, Dr. Reed has been in a nearly constant battle against the cancer. She has undergone major operations for recurrences in her abdomen, lungs and spine, and has received chemotherapy, radiation, immunotherapy and experimental treatments.

“It’s our new normal,” Dr. Noorchashm said. “I think the jury’s still out on how aggressively and successfully we can fight this. But we’re doing it anyway.”