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A Texas congressman and former gynecologist has taken the controversial position of blaming doctors for the spread of cancer during uterine fibroid removal procedures, as opposed to the laparoscopic power morcellators used during the minimally invasive procedures.
Power morcellators are medical devices used in recent years to allow surgeons to cut up and remove fibroids through a minimally invasive incision in the abdomen. However, concerns have emerged about the safety of the devices, since some women may have undiagnosed cancers contained within the uterus, which the devices may rapidly spread throughout the body.
Questions have been raised by many critics about the safety of the device and the FDA’s oversight, indicating that stronger warnings should have been provided about the potential cancer risks with morcellators.
According to a report by the Dallas Observer, Congressman Michael Burgess, a Texas “Tea Party” Republican, said recently that there was no problem with the design of power morcellators, but instead said that doctors should have known that shredding fibroids could potentially release cancerous cells into the body.
Debate Over FDA Regulation
The statements come amid debate over the “21st Century Cures Act”, which passed the House earlier this month and seeks to modernize the way the FDA approves new drugs and new medical devices, among other goals.
Another Republican, Mike Fitzpatrick of Pennsylvania, and a cancer survivor, called for the addition of an amendment that would require unique device identifier numbers to be added to electronic health records, so that it would be easier to identify specific medical devices used on patients.
The amendment was inspired by concerns over power morcellators, which were on the market for nearly a quarter of a century before the FDA recognized the risk that the device may be spreading undiagnosed uterine cancers during laparoscopic hysterectomy and myomectomy procedures for fibroid removal.
In response to the amendment, Burgess contends that, while he never used the devices himself, the FDA did not fail in its duties by not detecting the problem earlier. In fact, Burgess praised the agency, saying it has been good at issuing medical device recalls when necessary.
Instead, Burgess said that all doctors who operate on the abdomen should know not to grind up suspicious tumors because they could spread cancer cells.
Critics of the legislation, which now moves on to the Senate, say the bill lowers the clinical trial standards needed to approve drugs and medical devices, would increase overuse of antibiotics and the spread of drug-resistant pathogens, and would increase the ability of drug companies and medical device companies to discreetly pay doctors and medical professionals to promote their products without acknowledging the financial connection.
Power Morcellator Lawsuits
A number of families throughout the United States are now pursuing power morcellator lawsuits against manufacturers of the devices after women were diagnosed with the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following use of the medical device.
The complaints allege that power morcellators are unreasonably dangerous and that the manufacturers should have provided warnings about the potential risks associated with the device, so that women and the medical community could have decided whether the benefits provided by the minimally invasive laparoscopic procedure justify the potential risk.
The FDA has estimated that about out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus. For these women, morcellators may rapidly spread cancerous cells throughout the body, rapidly upstaging the cancers to an advanced stage that is difficult to treat and often fatal. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.
While the FDA has allowed laparoscopic morcellators to remain on the market, much stronger warnings are now provided about the potential cancer risks and many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.