·  Legal News, Analysis, & Commentary


FBI Investigates the Cancer-Spreading Hysterectomy Device

— May 28, 2015


Last year a Johnson & Johnson medical device, the laparoscopic power morcellator, was removed from the market. This year the FBI investigates the cancer-spreading hysterectomy device. The power morcellator was a favorite of surgeons for doing minimally-invasive hysterectomies and removing uterine fibroids. The device worked by grinding up tissue that could then be removed through small incisions.

The problem? If the patients had undiagnosed uterine sarcoma (a form of cancer), the morcellator spread it all around the abdominal and pelvic areas. The FBI is involved due to allegations that J&J, the biggest producer of the power morcellator, knew about the issue all along. In fact, the FDA sent out warnings about the device and increased cancer risk in April 2014. The warning stated that power morcellation may “significantly worsen…the patient’s likelihood of long-term survival.” It was so bad, that the FDA made manufacturer’s put a warning on the product label in November 2014.

The J&J division responsible for producing the morcellator, Ethicon, told doctors to stop using the device and pulled it from the market. Other companies’ morcellators were still available, though. According to an estimate by Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, roughly 60,000 morcellations were done every year before Ethicon pulled it from the market.

While J&J and Ethicon deny hearing from the FBI about the issue, one patient has been interviewed by the agency. Also one of the power morcellator’s biggest opponents, Dr. Amy Reed is one of the unlucky women who had cancer spread throughout her abdomen after a morcellation hysterectomy. Reed is an anesthesiologist and mother of six.

Dr. Hooman Noorchashm, Reed’s husband, said in an interview with CBS, that they had reached out to the FBI in late 2013 and “finally, agents in New Jersey listened.” The couple was interviewed by the agency in October 2014 and again just recently.

I don’t want to play armchair physician, but… Wait! I actually do want to do that! Perhaps it is because I’ve spent years as caregiver while my Mom dealt with cancer that I’m so familiar with the issue. Or maybe it’s because I pay attention to the news. It could be because I have a passing knowledge of basic human biology and a functional brain, but even I know that the last thing you want to do is to go painting someone’s insides with cancerous tissue!

Talk about a no-brainer, people! It amazes me that the geniuses behind this device – one that, quite frankly sounds better suited to a kitchen than an operating room – didn’t think of this first! Or, just maybe they did. There’s an FBI investigation in progress that may show that’s true. If it, may all the heavens help J&J and Ethicon because I can’t wait to see the totally justifiable lawsuits – and hopefully, budget-crushing verdicts – that will follow.

As a family-member of a (now former) cancer survivor, if it’s proven that J&J and Ethicon knew about this issue and did nothing… I want first crack at morcellating the ones responsible with their own cancer-spreading device.


Report: FBI investigating medical device that spread cancer in women

Join the conversation!