Last week, the FDA released a safety communication regarding laparoscopic uterine power morcellation. Laparoscopic power morcellators are medical devices used during certain gynecologic procedures such as hysterectomy and myomectomy (the removal of uterine fibroid tumors). Power morcellators essentially chop the tissue into tiny pieces that are then removed through small incision sites.
The concern with power morcellation in women with uterine pathologies is that if a woman has unsuspected cancer, the device could spray cancerous cells throughout the body. This is exactly what happened to anesthesiologist and mother of 6, Amy Reed. She and her husband, cardiothoracic surgeon Hooman Noorchashm, have campaigned against the device since Amy was diagnosed with stage IV leiomyosarcoma soon after having a hysterectomy and fibroid removal using a power morcellator.
Here is the actual text from the FDA’s safety statement issued on April 17, 2014:
“If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.”
One question readers may be asking is how could the FDA approve power morcellators for hysterectomy and myomectomy knowing that such a risk exists? Let’s briefly review the FDA device approval process. The level of FDA regulation is governed by the class to which a particular device is assigned by the FDA. Device classification is risk based, that is, the risk the device poses to the user is a major factor in determining the class to which it is assigned. In addition, device classification depends on the intended use of the device and also on indications for use.
The FDA uses 2 different standards to evaluate devices, the premarket approval (PMA) and a 510(k) process. The approval process for PMA devices is analogous to that for prescription drugs. That is, the FDA requires manufacturers of PMA devices to prove efficacy and safety by providing data showing the device’s performance in humans. The FDA also has the authority to regulate the promotion of PMA devices. As with prescription products, manufacturers of PMA devices cannot make false or misleading claims about their devices; they also must include warnings and contraindications in any advertisement.
In contrast, regulation of 510(k) devices is quite different. The FDA does not require human trials to prove efficacy and safety since these devices are considered to be at least as safe and effective as similar devices already on the market and do not raise any new questions about safety or efficacy. Instead, manufacturers of 510(k) devices must demonstrate only that these devices have the same intended use and are substantially equivalent to similar devices that were on the market before May 28, 1976. Additionally, the FDA has no authority over the advertising or promotion of 510(k) devices.
A quick search at the http://www.accessdata.fda.gov website shows that several power morcellators were classified as Class II devices and approved through the 510(k) process, meaning that no efficacy and safety trials were required. Here are the links to the approval letters for 3 such devices: http://www.accessdata.fda.gov/cdrh_docs/pdf5/k050639.pdf; http://www.accessdata.fda.gov/cdrh_docs/pdf13/k131656.pdf; http://www.accessdata.fda.gov/cdrh_docs/pdf9/K091100.pdf.
Would a more stringent device-regulation process have prevented Dr. Reed from developing stage IV leiomyosarcoma? We have no way of knowing the answer to that question. But it does demonstrate that both clinicians and patients need to be fully aware of the risks in order to make informed healthcare decisions. With no clinical trials necessary for devices approved through the 510(k) process, the only way to assess safety is through a retrospective review of the scientific literature.
Before issuing its statement last week, the FDA did analyze published and unpublished scientific literature of women operated on from 1980 to 2011 to determine the prevalence of unsuspected uterine cancer in patients with presumed benign pathology. The analysis showed that 1 in 352 women had 1 type of unsuspected cancer, uterine sarcoma, and 1 in 498 women had leiomyosarcoma. Granted, the prevalence of these types of unsuspected cancer is low, at only 0.3% and 0.2%, respectively. But to affected women and their families, these numbers are significant.
The results of this analysis have led the FDA to instruct manufacturers of power morcellators to review current product labeling to ensure that risk information is presented accurately for patients and clinicians. Additionally, the FDA may go one step further and require manufacturers to include a black box warning about the risk of cancer spread, but there is no such directive at this time. The FDA plans to convene a public hearing to gather additional information about the clinical role of power morcellation in hysterectomy and myomectomy and to determine whether additional safeguards should be employed to make these devices more safe and effective. For now, women and their healthcare providers should be aware of the risks associated with these devices and carefully weigh the risks versus benefits.