Government Reports Careless Oversight of Gynecologic Device

Lax Oversight Put Women at Risk of Cancer:

A recently released governmental investigative report has found that for more than 20 years, the U.S. Food and Drug Administration (FDA) has approved 25 surgical devices that may spread undiagnosed cancer in women’s bodies.

Because the devices were deemed significantly similar to prior devices—the devices were approved for surgical procedures on the knee and other joints—they were approved for use in gynecologic surgeries without rigorous testing, the U.S. Government Accountability Office (GAO) report found. According to Philly.com, the newer device, known as a power morcellator, which is meant to cut gynecologic tissue, may inadvertently spread aggressive cancers, a fact that the FDA was purportedly aware of with the new devices. Surgeons have also been advised to bear in mind the way in which manufacturers received federal regulator clearance for power morcellators in 1995, which was through FDA 510(k) route.

Under the 510(k) devices may be released to market without rigorous testing as long as they are “substantially equivalent” to another legally marketed device; clinical and human trials are not conducted should a device be found to be similar to a previously approved device. “Substantial equivalence means that the new device is at least as safe and effective as the predicate” device on which the new device was based. Meanwhile, the FDA considered morcellation risks too low to warrant a warning to women and their physicians, according to the GAO report’s conclusions.

The GAO also found holes in the FDA’s system for reporting deaths and serious injuries associated with medical devices. This means that hospitals and doctors either did not alert the government about problems or that health regulators did not see the reports.

In late 2013, the FDA finally began reviewing women’s cancer after married physician couple with six children who live in the Philadelphia initiated a high-profile campaign to ban power morcellators after a morcellator allegedly spread the wife’s undetected uterine cancer in October 2013 during a hysterectomy she underwent in Boston to treat benign fibroids.

In 2014, more than two decades after it approved the first gynecological morcellator, the FDA issued a warning that morcellators may spread and worsen uterine cancer. The FDA estimated the risk at one in every 350 women who undergo a hysterectomy or fibroid surgery would have an undetected cancerous tumor that may spread. The agency indicated that, for the most part, power morcellators should not be routinely used for gynecologic procedures.

“This GAO report is de facto confirmation that hundreds, if not thousands, of American women have been harmed or died because of this regulatory failure and the failure of the reporting system,” the woman’s husband said.

Former U.S. Representative Mike Fitzpatrick (Republican-Pennsylvania) and Representative Louise Slaughter (Democrat, New York) requested the GAO investigation in August 2015. Recently, Representative Fitzpatrick’s brother, Brian, who holds a seat in Congress and Representative Slaughter issued a statement concerning the GAO report indicating that, “The release of this long-awaited report won’t do anything to help women battling cancer who have had their lives devastated by power morcellators, or provide much comfort to the families of those already lost. It does, however, shed light on the broken system that allowed this devastation to happen and include a road map to address it.”

The GAO discovered that all 25 morcellators, including those that added accessories and features over the years, were deemed to be substantially similar as one predicate device, described as “an electromechanical system for cutting tissue during minimally-invasive surgeries performed on knees and other joints.” The GAO investigates how the government spends tax dollars and indicated that it discovered 30 medical journal articles published between 1980 and 2013 that discussed the risk of spreading tissue fragments when a power morcellator is used. FDA officials assumed the risk of spreading cancer was low, and “were not aware of any definitive scientific publications regarding the actual risk of cancer in uterine fibroids.”

The FDA issued a statement indicating that the agency “agrees with the findings” of the GAO report and noted it continues to warn that morcellators should rarely be used, that power morcellator labeling now contains a warning about the cancer risk, and that the system for monitoring safety problems is in the process of being improved. The agency pointed out that, “The FDA has noted the shortcomings of the current passive post-market surveillance system and has been taking steps to establish a better system to evaluate device performance in clinical practice.”

The personal injury attorneys at Parker Waichman LLP have years of experience representing clients in defective medical device lawsuits. The firm continues to offer free legal consultations to individuals with questions about filing a power morcellator lawsuit.

Morcellators and Increased Cancer Risks

When morcellators were first released, gynecologist saw them as a way in which to lessen the invasiveness of hysterectomy and fibroid removal, which, in turn, would then minimize complications and shorten recovery time. The procedure involves cutting up, or morcellating, uterine tissue and removing the tissue through small incisions in the abdomen. This method avoids the need for traditional surgery in which the abdomen is cut open.

Government Finds Careless Oversight of Gynecologic Device

Government Finds Careless Oversight of Gynecologic Device

When the couple drew media attention to the problem, new scientific analyses were prompted. Those gynecologists who then-informed women of the potential danger said the risk was about one in 10,000 and many gynecologists did not warn patients. “The gynecological literature contained clear indications that this oncological danger of power morcellators exists, but neither practitioners nor the FDA addressed the hazard,” the husband, a cardiac surgeon, said.

The controversy abruptly stopped the routine use of morcellators, the leading morcellator brand was pulled from the market, and insurers are now concerned about coverage. “There are sure to be other hazardous devices causing unreasonable harm to American patients as a result of the failures defined by this report,” the husband said, calling for “immediate formal attention” by Congress and the Trump administration. Meanwhile, the new president has promised to reduce federal regulations, recently signing an executive order that would mandate agencies to revoke two rules for every new one they issue.

Filing a Personal Injury Lawsuit

Parker Waichman is a national personal injury law firm that represents clients in drug and medical device lawsuits. If you or someone you know suffered a medical device injury, including an injury involving a power morcellator and want to learn more about filing a personal injury lawsuit, contact our firm today by calling 1-800-YOURLAWYER (1-800-968-7529).

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