Correction: A previous version of this article said Sarah Salem-Robinson was a gynecologist’s assistant. She was a physician assistant. This version has been corrected.
Sarah Salem-Robinson had worked for more than a decade as a physician assistant, so she was familiar with treatments for fibroids. When she herself was diagnosed with the noncancerous uterine growths, she immediately resisted a common laparoscopic procedure recommended by her doctor.
The procedure involves a device called a power morcellator to cut fibroids into small pieces, which then are removed through minimally invasive incisions. Worried that one of her fibroids might be a malignant tumor and that the procedure could spread undetected cancer, Salem-Robinson instead wanted a traditional “open” hysterectomy, in which the entire uterus is removed through a large abdominal incision.
“I’ve seen a morcellator work. I’ve seen it splatter,” said Salem-Robinson, a resident of Los Altos, Calif. “I know it’s not the way to operate on tumors.” But she said she was assured that she didn’t have cancer and underwent the laparoscopic procedure in May 2012.
Two weeks later, she was told that one of her fibroids was actually a uterine leiomyosarcoma, a rare and aggressive form of “occult,” or hidden, cancer. She began aggressive treatment but “subsequently developed four small lesions in one of her lungs that likely represent metastatic leiomysocarcoma” resulting from the morcellator, according to a lawsuit she has filed against the device manufacturer.
With reports such as Salem-Robinson’s proliferating since late last year, the Food and Drug Administration issued an alert in April urging doctors to stop using the laparoscopic procedure — either for the removal of fibroids or the entire uterus. It warned that the surgery “poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.” It also estimated that one in 350 women with fibroid surgery has undetected cancer that can potentially be spread by the procedure.
Now the agency is considering further steps, including adding a “black box” — its most serious safety warning — to the product labeling for the device. A panel of outside FDA advisers will hold a hearing on the issue Thursday and Friday.
Advocates for the minimally invasive treatment argue that it is beneficial for most women with fibroids because it reduces the risk of complications from open surgery and reduces recovery time. But many critics say the power morcellator carries an unacceptable risk and should be banned.
“Until we have a means of pre-operatively identifying the few women with leiomyosarcoma instead of fibroids, this technology should be banned,” said David R. Challoner, vice president emeritus for health affairs at the University of Florida.
The hearing also is likely to focus on the FDA’s method of approving medical devices, called the 510(k) process. Challoner, the lead author of a 2011 Institute of Medicine study that said the process was faulty, said in an interview that “the morcellation disaster is yet another tragic anecdote of the failure of 510(k).” In many cases, manufacturers are required to demonstrate that a device is substantially equivalent to a product already being sold and aren’t required to conduct clinical trials. Once on the market, critics said, devices aren’t monitored adequately.
The FDA defended its approval process. “The evaluation of medical devices is always a balance of benefits and risks and getting important new technologies to patients quickly that are safe and effective,” William Maisel, deputy director for science at the FDA Center of Devices and Radiological Health, told reporters in April.
Before last December, the FDA had not received any reports linking the morcellator to cancer, but by March it had “dozens” of them, according to an agency spokeswoman. That in large part was because of a public campaign launched by Boston anesthesiologist Amy Reed, and her husband, Hooman Noorchashm, a Harvard-affiliated physician, after Reed was diagnosed with Stage 4 uterine cancer following morcellation.
“People would just go home and die,” said Noorchashm, whose efforts to publicize the issue prompted other women to make public their own experiences with the procedure.
The biggest manufacturer of morcellators, Ethicon, a subsidiary of Johnson & Johnson, halted sales of morcellators after the FDA’s April recommendation but has not issued a recall.
“Ethicon morcellation devices have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue,” said spokesman Matthew Johnson.“We believe this meeting will help the medical community better assess and evaluate the role of powered morcellation devices moving forward.”
Some large physicians groups said that the device remains effective and beneficial for many women. The American Congress of Obstetricians and Gynecologists and the AAGL, an association of gynecologists specializing in minimally invasive surgery, argued that a ban would deny women minimally invasive treatment that reduces the risks of open surgery, particularly for obese patients. Jubilee Brown, a gynecological oncologist and an AAGL spokeswoman, said there is no “perfect scenario where you can exclude all risk,” but that until there was “sufficient evidence” on the risks of power morcellation, there should be no ban.
A number of hospitals, including the Cleveland Clinic, have stopped using the device since the FDA issued its recommendation in April. Marie Fidela Paraiso, a gynecologist at the medical center, has been performing morcellation treatments since the device was introduced in the 1990s. “For years, we’ve known there’s this risk,” she said, but added that the FDA’s latest figures on the rates of a “surprise” sarcoma were much higher than she had thought.
“We can support suspending the device until we find out what’s safest for our patients, but I don’t think it should be eradicated,” Paraiso said. “We need to educate patients of the risks and offer alternatives to this technique.”
In May, Salem-Robinson sued Richard Wolf Medical Instruments, the maker of the power morcellator. The company did not respond to requests for comment on the suit. She also has filed an arbitration demand with the Kaiser Permanente Santa Clara medical center, where she underwent the morcellation, and where she was been employed for the past three years. She has been on disability leave for the past year after rounds of cancer treatment.
She said that she believes that Kaiser puts pressure on doctors to hold down hospital stays and costs, and sets goals for certain surgeries, and for that reason, she believes she was encouraged to undergo the minimally invasive surgery.
“Meeting the needs of our female patients with health care that is safe, reliable and of high quality is an important part of our mission at Kaiser Permanente, and this includes an evaluation of laparoscopic power morcellators procedures in light of FDA guidelines,” a Kaiser spokesman responded by e-mail. “Our sympathies go out to this patient and her family.”
Colleen Daley’s sister Patricia, a 56 year-old information desk worker at the Government Accountability Office, was a post-menopausal woman with a family history of cancer – high risk factors for uterine leiomyosarcoma.
Daley said her sister was terrified of cancer and believes she was never informed of the risks of morcellation when she sought treatment for fibroids. Four months after her surgery, she collapsed in work with pain, and when doctors reexamined her, they found 13 tumors in her abdominal cavity. Her dying wish, three months later, was that something be done to protect other women.
“Even if it’s only 1 percent of women, this could be your mother, your sister,” says Daley. “What are two small incisions or a speedy recovery worth when you’re dead?”