In response to last month’s letter from 12 U.S. congressmen, the U.S. Government Accountability Office (GAO) has announced plans to begin an investigation into power morcellators, the controversial medical devices that are used in noninvasive hysterectomies and myomectomies.
The congressmen sent the letter to the GAO asking the agency to investigate why the FDA took until April 
2014 to issue a warning against power morcellators in most women with uterine fibroids because of the risk of spreading undetected cancer.
Specifically, the GAO was asked to investigate if the expedited 510(k) approval process used by the FDA to clear the power morcellator missed the cancer risk potential of the device before it was approved, and whether manufacturers and the FDA have appropriately monitored problems.
FDA Warnings
The FDA has said that the extent of the risk associated with morcellation wasn’t known until the issue came to light in late 2013, when the agency began researching how the devices could cause harm to women harboring undetected uterine cancer.
Since the FDA issued that first warning about power morcellators in April 2014, use of the device has lessened dramatically. Johnson & Johnson, once the largest manufacturer of the device, voluntarily pulled its morcellators off the market in July 2014. In October 2014, the FDA ordered that a Black Box Label warning, its strongest caution, be added to the device.
Studies Show Morcellators Pose High Risk
Power morcellators have been on the market since 1991, and numerous studies have established the high risk they pose for spreading uterine cancer. Critics of morcellators say they endanger women’s lives and therefore should be banned because they also spread and worsen hidden cancers.
Many major insurers have either dropped or restricted coverage of procedures involving morcellation, and as a result, fewer surgeons are using the devices. The power morcellator is blamed for hundreds of deaths and is the subject of numerous lawsuits pending across the U.S.
If you or a loved one have been diagnosed with cancer that was spread by a power morcellator during surgery, you need to make sure you know your legal options. You may be entitled to compensation from the company that manufactured the device that caused this horrible ordeal.
Contact the power morcellator attorneys at Childers, Schlueter & Smith today. Consultations are free and without obligation.
Other Morcellator News
A recent study links the FDA’s morcellation warning to increased invasive surgeries for uterine fibroids, raising concerns about reduced access to minimally invasive treatment options for women.
Olympus America is redesigning its power morcellator with a containment system, but the FDA remains concerned about cancer risks. Legal and safety questions persist amid ongoing clinical trials and lawsuits.
The GAO report finds the FDA underestimated cancer risks from power morcellators, highlighting gaps in postmarket device monitoring and raising concerns for patients undergoing fibroid surgeries.
Johnson & Johnson has settled nearly 70 lawsuits over its laparoscopic power morcellator, with cases citing risks of spreading undetected cancer. Additional claims remain pending in multidistrict and state court litigation.
Federal courts have consolidated morcellator cancer lawsuits against Johnson & Johnson and Ethicon, streamlining pretrial proceedings for women alleging the device spread undetected cancer during surgery.
A new amendment inspired by power morcellator concerns has passed the U.S. House, aiming to strengthen medical device safety monitoring and prevent patient harm through improved tracking and accountability.
