New proposed legislation that would require doctors to report potentially serious problems with medical devices to the U.S. Food and Drug Administration was inspired by the use of a women’s surgical tool at the center of a number of lawsuits.

The “Medical Device Guardian’s Act,” proposed in June by House Representatives Mike Fitzpatrick (PA-Rep) and Louise Slaughter (NY-Dem), aims to help raise awareness of the possible risks of medical devices that could cause harm to patients. The congressmen said they were motivated to change the law after delayed warnings to the FDA about the laparoscopic power morcellator.

The power morcellator is a surgical device used in gynecologic procedures, including removing fibroid tissue and hysterectomies. The device allows a surgeon to cut up and remove problematic tissues through smaller incisions. Although most of the tissue is removed, some of it may remain and spread to other parts of the uterus and body. This is a problem if the tissues are cancerous, something that is rare and typically learned after the surgery when pathologists have the tissue tested.

“The evidence that has been uncovered is showing that there’s a very strong association between the use of these devices and what’s called the upstaging of undiagnosed uterine cancer,” explained personal injury attorney Brian Bogle with the Levin, Papantonio law firm. “Upstaging means, the patient who underwent the surgery has no idea that they have cancer, nor their doctor. By performing this morcellation procedure they actually chop up this cancerous tissue and throw it into the uterine cavity and sometimes even further, which spreads or upstages that cancer.”

According to Fortune magazine, when the devices first came on the market in the 1990’s there was some evidence the power morcellator could spread a rare but dangerous type of uterine cancer. However, the FDA didn’t receive any direct reports until late 2013 and it wasn’t until 2014, that the FDA added a “black box warning” on the device about the potential dangers.

Manufacturers of the device have been under fire for failing to provide adequate warnings about the risks. Currently, the FDA requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices to the agency’s database of adverse events.

Doctors don’t have to report, although they are encouraged to do so. The proposed legislation would add doctors and doctors’ offices to the list of mandated reporters. Lawmakers hope that will help improve the process of reporting problems with medical devices, to better protect patients and catch issues earlier.

“The FDA has been taking steps to warn patients and look into problems,” said Bogle. “They’ve stated pretty strongly they should not be used for the vast majority of women undergoing fibroid removal or hysterectomy procedures. They’re also now contraindicated for folks with known cancer and people could undergo a different procedure to address the same physical issues.”

The Government Accountability Office is now looking into problems with the device and Johnson & Johnson suspended sales of its power morcellator in April 2014, and withdrew it from the market a couple of months later. Lawmakers hope earlier and more frequent warnings will help alert the public sooner of any potential problems with any medical devices, and give patients the option of choosing a different procedure.

The FDA is aware of the gaps in tracking serious device risks and says the bill isn’t a cure-all. The agency also has plans for a national evaluation system that would, among other steps, use data generated during patient care to identify safety issues more quickly.

If you underwent a procedure where a power morcellator was used, there are steps you can take to ensure you’re not at risk.

“It’s warranted to go back and speak to the physician who performed the procedure just to check you and make sure you don’t have any underlying medical issues that need to be addressed,” said Bogle. “You should speak to an attorney to get your legal rights evaluated and see if there’s a claim that should be brought on your behalf.”

If you or someone you know has been injured the Levin, Papantonio law firm is here to help. Contact us for a free confidential consultation, at (850) 435-7000 in Pensacola or toll free at (800) 277-1193. You can also request a free private and confidential evaluation and an attorney with our firm who handles your specific type case will immediately review it.

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Mollye is a journalist, investigative reporter, and former news anchor. She graduated from the University of West Florida in 1996 with a Bachelor’s in Communications Arts. She worked as an anchor and reporter for WEAR-TV 3 (an ABC affiliated) in Pensacola for nearly twenty years. She has also served as a television host and journalist with BLAB-TV and the Studer Community Institute.