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Amid continuing concerns over the failure to recognize that women may face a risk of serious cancer problems following a laparoscopic hysterectomy involving morcellation, some law makers are pushing the FDA to overhaul its “fast-track” 510(k) medical device approval process.
In recent months, Senator Robert Casey and Representative Michael Fitzpatrick, both of Pennsylvania, have been pressuring the FDA to take a closer look at potential failings of the program, which they say have allowed morcellators and other devices with potentially deadly side effects to go on the market without thorough testing.
Morcellators are medical devices used in recent years during minimally invasive hysterectomy and myomectomy procedures, allowing the doctor to cut up and remove the uterus or uterine fibroids through a small incision in the abdomen.
Years after the devices hit the market and became widely used within the medical community, morcellators have been linked to a risk of deadly problems for some women who have hidden or unsuspected cancer, potentially spreading leiomyosarcoma, endometrial stromal sarcoma or other cancerous tissue contained within the uterus. The rapid dissemination of the cancer to other areas of the body may greatly impact the woman’s chances for long-term survival and impact their overall quality of life.
Last month, Congressman Fitzpatrick addressed the FDA at a workshop on post-market surveillance of medical devices, indicating that the agency needs to do more to prevent devices like morcellators from slipping through regulatory gaps in the approval process.
In a recent letter, Senator Casey asked what the FDA was doing to address issues with manufacturers failing to report adverse events associated with their products and how the agency decides when it needs to force a medical device recall or let the manufacturer do so on its own.
The 510(k) program allows medical devices to be approved with little to no pre-market testing requirements. In most cases, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. However, the definition of “substantially equivalent” is vague, with many manufacturers seeking approval for devices under the program while at the same time boasting that the devices are new and innovative, which many critics say means they cannot be equivalent to devices already on the market.
The FDA has not responded to the inquiries publicly, but according to a story on Medscape.com, the agency has been in private contact with both lawmakers’ offices.
Hysterectomy Morcellator Cancer Problems
Although the FDA approved the first electronic morcellator in 1993, the agency did not issue warnings about the cancer risk following a hysterectomy or myomectomy until April 2014.
At that time, the agency announced that it was investigating the potential for cancer problems, estimating that one out of every 350 women undergoing a laparoscopic hysterectomy or myomectomy may have unsuspected sarcoma.
An FDA advisory panel was convened last summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
Manufacturers of the devices now face a growing number of hysterectomy morcellation cancer lawsuits filed on behalf of women diagnosed with advanced stage cancer after the device was used, alleging that inadequate warnings were provided for consumers and the medical community.