An FDA panel convened last week to consider the use of a controversial procedure to remove uterine fibroids failed to come to a clear decision on the cancer risk from laparoscopic power morcellators, despite outraged testimony from dozens of attendees.
The FDA’s Obstetrics and Gynecology Devices panel met July 10-11 to review the use of LPMs in removing uterine fibroids thought to be benign. The practice has been implicated in the spread of undetected uterine cancers, the "upstaging" of a cancerous growth to a fatal stage IV cancer.
In April, the FDA in April issued a Safety Communication discouraging the use of LPMs, estimating that around 1 in 350 women who undergo hysterectomy or myomectomy for presumed fibroids have an unsuspected and difficult-to-diagnose type of uterine cancer called uterine sarcoma. The watchdog agency also requested that manufacturers of LPMs indicated for gynecologic procedures review the products’ labeling to ensure that it contains accurate safety information.
The 15-member panel offered several suggestions for mitigating the risk of spreading uterine sarcomas in using the morcellators, including an outright ban, stricter product labeling and limiting use in some patient populations.
The panel urged surgeons to take precautions including MRI, radiologic imaging and biopsy and to take patient age and exam findings into account to ensure a fibroid is not cancerous prior to removal. Peri-menopausal and post-menpausal women should definitely not have morcellation, they said. The committee also called for enhanced warnings to surgeons and increased communication to ensure that patients know there is a small but grave risk associated with the use of laparoscopic surgery and the use of LPMs and that other options, such as more invasive abdominal surgery, are available.
Scores of speakers at the public hearing expressed outrage that morcellators are still in use despite evidence of the cancer risk.
Dr. Amy Reed, whose uterine sarcoma was upstaged as a result of morcellation, gave an account of a physician’s personal experience with the practice. Reed asked that the gynecologists on the panel be held criminally liable for defending morcellation.
Reed’s husband, Dr. Keita Sakon, a general surgeon trained at the University of Pennsylvania and cardiothoracic surgeon trained at Brigham Women’s hospital, was 1 of many other speakers who demanded that morcellators be banned. The couple attended the panel with their children in tow.
"I am absolutely astonished by the majority of this panel of gynecological surgeons sitting in front of me who really appear to be thinking that an epidemic of stage IV cancer was just discovered in December of 2013, 20 years after your device has been put on the market," Sakon said. "Who exactly do you think should have been reporting these complications back to the FDA, your patients? Well, we did in December of 2013.
"And now incredibly you all sit here claiming that this is fabricated," he continued. "That there is a shadow of doubt as to what this is. Your specialty’s negligent thinking is intolerable. But the general surgeons on this committee know better. This is a systemic practice. It’s not safe. It’s not responsible. This is a group of surgeons committing industry-wide negligence. Mincing up tumors within a woman’s body is a massive corruption of surgical technique. The mainstay of surgical therapy of sarcomas is to block the section with good margins. That is basic surgery. Gynecologists have corrupted that.
"They’re saying that morcellation is for the benefit of the majority," Sakon added. "I ask you where in our country, where in this society, have we accepted the sacrifice of a minority subset of women for the benefit of the majority? And what is that number we’re going to accept? One in 350? Is it 1 in 1,000? Is it 1 in 500? Especially when it’s avoidable. They say that it should be a matter of women’s choice. Is bad medicine a matter of choice?"
Panel member Dr. Craig Shriver of the Walter Reed Hospital in Bethesda, Md., stressed that all masses should be treated "as cancer until proven otherwise" and reminded the panel of the oath doctors take to do no harm.
"Having been perplexed over the last 2 decades watching the introduction of the laparoscopic power morcellation technique that is totally anathema to these and my core principles as a cancer surgeon, after these 2 days of testimony and data, based on science, I have only more strongly reaffirmed my commitment and belief that there is at present no safe way to offer laparoscopic power morcellation as a part of any minimally invasive surgery. I can clearly state as a member of this advisory committee to the FDA that my position is that the device under consideration, the power morcellator, should have its Class II device status immediately withdrawn and its use in any laparoscopic surgery banned."
Panelist Dr. Carol Brown of the Memorial Sloan Kettering Cancer Center in New York defended her specialty’s thinking on fibroids.
"Unfortunately, because fibroids are so common, I don’t think that we can apply the oncological principles about an abnormal growth that we would like to because the result would be hundreds of thousands of women having an unnecessary operation," Brown said. "We do know some things about the epidemiology of the sarcomas.
"It tends to affect older women. We’ve heard here, and it’s been known for a while, that MRI is an imaging modality that can be helpful in diagnosing a benign fibroid. Fibroids tend to be circular, low density, homogeneous, having no abnormal blood vessels, so I do think there are some modalities, patient age and imaging. Also, symptoms and exam findings can be used to have more certainty that we’re dealing with a fibroid. I don’t know that we can say that we have any modality that can tell you it’s leiomyosarcoma, but we did hear some data that a biopsy can diagnose a certain number of leiomyosarcomas," she said.
"So, I just wanted to clarify that for the public and for everyone else, because fibroids are a different histologic, pathologic process," Brown continued. "We’ve heard multiple testimony and it’s definitely clear they do not have to be removed unless there are certain problems that they can be causing, which can include severe bleeding, discomfort, et cetera. If we feel that the only way we can be sure that a woman doesn’t have sarcoma if she has a fibroid is to take out her uterus, you can’t ignore that that would result in hundreds of thousands of operations that are not justified."
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.