FDA Provides Guidance on Tissue Collection Systems For Power Morcellators
As part of a continuing effort to minimize or eliminate the power morcellator cancer risks, which may spread cancerous cells throughout the body during uterine procedures, federal regulators have issued a draft guidance outlining the steps required to test and implement tissue collection systems.
The U.S. Food and Drug Administration (FDA) released the draft guidance, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures, on June 21, which provides an updated series of recommendations on how to ensure cancerous cells are not released from power morcellator containment systems during procedures.
Power morcellators are medical devices which became increasingly popular in laparoscopic hysterectomy and uterine fibroid procedures, allowing surgeons to cut up the tumor or uterus and remove the tissue through a smaller incision. They were widely used for a time due to the reduced recovery time and the reduced risk of infections or other complications. However, a percentage of women undergoing these procedures have undiagnosed sarcoma, which doctors did not detect prior to the procedures. This led to power morcellators falling into disuse following a number of studies and warnings by the FDA which indicated the morcellators were releasing cancerous cells, which could spread, when used to remove uterine fibroids.
The revelations led to medical device manufacturers facing a series of power morcellator cancer lawsuits over the risk the morcellator may cause the spread of cancerous tissue throughout the abdomen and pelvis.
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Power morcellator lawsuits raised allegations that manufacturers knew or should have known about the unreasonable risk associated with morcellation during a hysterectomy or uterine fibroid removal surgery, and they withheld information from the medical community and failed to take steps to ensure that their products were safe.
Some manufacturers have tried to develop morcellation systems that keep cancerous cells from spreading. This latest FDA draft guidance applies to the tissue containment systems used during power morcellation procedures, and will provide gynecologists recommendations on test methods, test parameters and test acceptance criteria, which they should use to determine if such systems are effective.
The FDA indicates these recommendations will “promote consistency and facilitate efficient review of gynecologic and general laparoscopic power morcellation containment systems submissions” and “are being made to ensure that the non-clinical test methods can effectively identify safety issues related to damage of the tissue containment system and subsequent leakage of any cancer cells and other contents.”
Power Morcellator Concerns
In November 2014, the FDA decided to add a black box warning to power morcellators about the cancer problems, and provided guidance on the limited instances where laparoscopic hysterectomies may be warranted.
While the medical community has largely abandoned the use of morcellators due to cancer risks, the FDA has been criticized for failing to obtain the necessary data through power morcellator post marketing surveillance, which the FDA is supposed to use to ensure that devices approved for use on patients in the U.S. are safe and effective in the real world.
In February 2017, the U.S. Government Accountability Office (GAO) released a report analyzing the FDA’s response to power morcellator cancer risks. The report found that a lack of data led the FDA to likely underestimate the risk that morcellators were spreading uterine cancer among many women, with 25 devices approved before the problems were detected.
Following the warnings, many power morcellator manufacturers such as Johnson & Johnson have faced hundreds of morcellation cancer lawsuits brought on behalf of women who developed Leiomyosarcoma, Endometrial Stromal Sarcoma, and other uterine cancers.
While most of those cases have been resolved through morcellator settlement agreements, a number of other morcellator manufacturers continue to face claims alleging that they failed to warn the medical community about morcellator risks.
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