Power Morcellator Reportedly Under Investigation by FBI

Consumer Drug Safety
by admin

Morcellators, a medical device used to destroy uterine fibroids, have been in the news a great deal lately. Most recently, the FBI is reportedly investigating the device to determine if the claims it spreads cancer are true. Johnson & Johnson, the country’s largest manufacturer of morcellators, pulled their device from the market in 2014.

The FBI is interested in learning whether or not Johnson & Johnson failed to take action when they became aware of the dangers of the device.

Laparoscopic power morcellators are used by surgeons during hysterectomy and uterine fibroid procedures, allowing them to perform the surgeries in a minimally invasive manner. The device works by grinding up tissue, making it easy to remove through small incisions. This reduces the risk for infection and lessens recovery time following the procedure.

Morcellators and the Spread of Cancer

Unfortunately, when the device is used on women with undiagnosed cases of uterine sarcoma cancer, it spreads the cancer cells throughout the abdomen and pelvis. This leads to a more aggressive case of cancer, which has proven devastating for those affected.

The warning about cancer risks and morcellators came from the US FDA in the spring of 2014. The administration stated morcellation use could “significantly worsen… the patient’s likelihood of long-term survival.” Seven months later the FDA required a stronger warning label on the product. Shortly after, Johnson & Johnson’s Ethicon division advised doctors to stop using the morcellator and pulled the devices from the market.

Up until the warnings about the risks, about 60,000 morcellation procedures were performed each year.

The FBI is in the process of interviewing victims of morcellation procedures. One such person, advocate Dr. Amy Reed, underwent a morcellator hysterectomy in 2013. Shortly after, test results showed cancer had spread throughout her abdomen. Dr. Reed is now an outspoken critic of the devices, and her husband, Dr. Hooman Noorschashm, is also an avid critic and frequently posts online regarding the device. He recently told CBS News the couple began contacting the FBI in 2013 and finally, as he puts it, New Jersey agents took action.

Morcellation Not Banned

Despite Johnson & Johnson pulling their morcellators from the market, there are other manufacturers that continue making the devices. Some doctors still regard morcellation as an effective and safe method for dealing with uterine fibroids and for performing hysterectomies. They believe that as long as proper evaluations are conducted in advance to ensure a patient is healthy, morcellation poses little to no threat and actually makes what would otherwise be a difficult surgery safer. Morcellator use continues to be a hotly contested topic at gynecological conferences.

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