FBI Investigating Medical Device that Spread Cancer in Women

Written by Jeff Meyer on 29 Jun 2015

The Federal Bureau of Investigation has reportedly launched an investigation into a medical device that has been commonplace in uterine surgeries for years. Investigators are especially interested in Johnson & Johnson, once the largest manufacturer of this tool. Their corner of the market was relinquished after the multinational corporation withdrew their products and ceased production last year.

Risks Associated with Power Morcellators

At the center of this controversy is the power morcellator. This surgical instrument has been in use since 1993, allowing surgeons to remove benign growths from women’s uteri known as fibroids. These growths are generally benign, but prior to morcellators, getting to them would mean the surgeon would have to make an incision large enough that they could use a scalpel or some similar device to clear the fibroids out.

With a power morcellator, the surgeon could make a much less intrusive cut. Then the morcellator was slid through and the spinning blades at its head were aimed at the fibroids.

Unfortunately, it’s been learned that these machines can sometimes do more bad than good. Even though the patient is going in to have benign tissues removed, she could wake up with malignant cells growing in her body. That’s because the spinning blade on a power morcellator sometimes throws the cells around once it’s done clearing them. These can eventually proliferate and become actual cancer.

The FDA Stepped In

Much of this came as a surprise to the medical community when the FDA issued a warning last April. Also shocking was the estimate they quoted to help support their words of caution: one in 350 women who think they have non-cancerous fibroids actually has cancerous cells. The specific cancer in question is uterine sarcoma, a soft-tissue version that can be very difficult to treat.

By some estimates, roughly 60,000 uterine procedures were carried out every single year. How many women have been affected since 1993 is unknown, but hundreds have come forward as examples of what can go wrong.

Johnson & Johnson Reacts

Despite their strong words, the FDA stopped short of taking any real action in terms of removing the device, though new warnings were added. Therefore, many were surprised when Johnson & Johnson announced they would no longer make or sell these instruments any more. Any company taking such a proactive step would be surprising, but Johnson & Johnson was the number one manufacturer of these tools in the entire world.

The FBI Gets Involved

When Dr. Amy Reed, an anesthesiologist, needed to go in for uterine surgery, the mother of six became a victim of a surgeon’s morcellator. Over the past two years, she has had to undergo a number of surgeries to address a tumor located near her spine.

Reed also took it upon herself to try to protect other women who may unwittingly end up with cancer. She contacted the FBI, which is now investigating these tools. Reportedly, they’re especially interested in Johnson & Johnson.

The idea seems to be that even though it appears as though the corporation did the right thing by taking the FDA at their word, there may be more to it than that. Instead, it’s possible Johnson & Johnson knew of the risks involved but only acted when they realized the FDA would soon be cracking down.

As it stands, the future of this device is very much up in the air. However, for now, they are still legal to use, though surgeons have obviously been warned of the risks involved. If you or someone you know is scheduled to have uterine surgery, make sure to talk to the surgeon about concerns regarding morcellators.

Source:

http://www.cbsnews.com/news/fbi-investigating-medical-device-that-spread-cancer-in-women/

Posted Under: Blog