Lax Reporting Concern Over Incidences Involving Medical Devices

Reporting Concern Over Incidences Involving Medical Devices
Reporting Concern Over Incidences Involving Medical Devices

A recent government report said that The U.S. Food and Drug Administration (FDA) has been responsible for approving 25 surgical devices over more than two decades that may spread undiagnosed cancer in women. These medical devices were judged to be similar to older devices, for knee and other joint surgeries and subsequently approved for use in gynecologic surgeries without stringent testing, the U.S. Government Accountability Office (GAO) reported.

The FDA had knowledge that the newer devices, specifically the power morcellator, could inadvertently spread uterine cancer, but deemed the risk too low to alert women and their doctors, the GAO noted.

The GAO concluded that gaps in the FDA’s system for reporting serious injuries or deaths related to medical devices meant that physicians and hospitals either did not alert the government about the issues, or health regulators did not even see the reports.

Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from power morcellators.

Campaign to Ban Electric Morcellators

A high-profile campaign was launched to ban electric morcellators by a married physician couple after the wife’s undetected uterine cancer spread, during a hysterectomy in October 2013 to treat benign growths (fibroids). The woman, an anesthesiologist, is to this day, fighting leiomyosarcoma that has since spread to numerous organs, despite aggressive treatment. The FDA began studying women’s cancer risk in late 2013 on the heels of this couple’s campaign.

In over twenty years after the FDA first approved the first gynecological morcellator, the agency warned that the device could spread and worsen uterine cancer. That is an estimated risk of one in every 350 women who undergo a hysterectomy or fibroid surgery. It was only then that the FDA said the device should not be used in the “vast majority of cases.”

“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,” said the woman’s husband who is a cardiologist.

An initial GAO investigation was requested by former U.S. Representative Mike Fitzpatrick and U.S. Representative Louis Slaughter in August 2015. Recently, Fitzpatrick’s brother who now holds his seat in Congress, and Rep. Slaughter, issued a statement: “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 FDA responded with a statement saying it “agrees with the findings” of the GAO and that the agency noted that it continues to warn that morcellators should rarely be used. In addition, the device labeling now has a warning concerning the cancer risk, and that the system for monitoring safety issues is being improved.

The statement said, “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”

Power Morcellator Background

When the morcellator was first introduced to the market, it was embraced as a progressive method with numerous benefits. It was a less invasive procedure, requiring less recovery time, as well as a reduction of complications. A small abdominal incision is made, where morcellated uterine tissue can be cut up and removed in what seemed to be a preferable procedure to traditional surgery.

Reporting Concern Over Incidences Involving Medical Devices
Reporting Concern Over Incidences Involving Medical Devices

Manufacturers of morcellators were able to get FDA approval through a “fast track” process called 510(k). This enables the device to come to market without rigorous testing provided the device is “substantially equivalent” to another similar device that had already been FDA approved. The FDA notes, “substantial equivalence means that the new device is at least as safe and effective as the predicate” device that it is based on.

The GAO which monitors how the government spends tax dollars, said it discovered 30 medical journal articles published between 1980 and 2013 that told of the risk of spreading tissue fragments while using a power morcellator. However, the 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.”

Legal Advice and Information Concerning Medical Devices

Parker Waichman LLP has had years of experience representing clients in numerous allegedly defective medical device lawsuits. The firm offers free legal case evaluations to anyone with questions about filing a lawsuit over adverse effects from medical devices, including power morcellators. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).