Doctor with Cancer Raises Alarm Regarding Medical Device

Written by Jeff Meyer on 29 Jun 2015

Is the Food and Drug Administration doing everything it can to protect patients from medical devices that could be potentially dangerous? Two doctors in Philadelphia don’t think so. That’s why they’re fighting to prevent further tragedies, despite the fact that they are currently wading through their own medical nightmare.

The Case of Dr. Amy Reed

Dr. Hooman Noorchashm and his wife Dr. Amy Reed have been battling since Reed, 42, was diagnosed with cancer two years ago. Obviously, no one ever wants to hear the news of this kind of diagnosis, but for Reed, it only got worse.

It all began with surgery Dr. Reed underwent to get rid of some uterine fibroid tumors. To do this, surgeons used a common device for this kind of operation called a power morcellator. This handheld tool has sharp blades at the other end that can move in a spinning motion in order to shred away at, in the case of Reed’s surgery, the tumors that had to be removed. Due to the size of the tool, just about any area of the body could be accessed with only a minor incision. However, its purpose is to access the uterus when tumors need to be removed.

Unfortunately, the blades of the power morcellator didn’t just tear away at her tumors. They actually spread some cancer that hadn’t previously been detected throughout her body as well.

This is what happened to Dr. Reed. After her surgery, she received another diagnosis. Since then, she had had to go through even more surgeries and further rounds of both radiation and chemotherapy. Recently, she suffered a recurrence when doctors found a tumor on her spine.

A Device with a Past

This isn’t the first time power morcellators have been blamed for inadvertently making matters worse. The machine has received so much bad press that Johnson & Johnson actually pulled theirs off the market last year. Their decision to do so came after the FDA went public with the risks associated with using this machine.

However, the FDA stopped short of issuing an all-out recall. According to them, the machine may still prove effective for some women, albeit a small number of them.

Getting the FBI Involved

For Dr. Reed and her husband, the damage down to her by the use of a power morcellator was not something they would simply accept. The mother of six got busy taking matters into her own hand.

According to Noorchashm and Reed, more should have been done to keep patients safe. They aren’t satisfied with the FDA’s warning to surgeons and have actually spoken to investigators at the FBI about their concerns. Noorchashm told reporters that the device is leading to death in violation of federal law, so the FBI seemed like the right agency to speak to.

To anyone who may take this claim lightly, the truth is that the FBI apparently isn’t. The Wall Street Journal reported back in May that they had already begun investigating what Johnson & Johnson may have known about risks associated with using power morcellators. Apparently, problems were brought to their attention as early as 2006.

Had action taken back then, Dr. Reed could have been spared her current predicament. Sadly, the same can probably be said for hundreds of other women too. If the machine continues to be used, the fear is that hundreds of more women may have to find out the hard way about the risks involved.

At the moment, power morcellators carry a warning on their box, but are still legal for a surgeon to use. If you or a woman you know is going in for any kind of surgery involving her uterus, it would make sense to speak with the surgeon first about the risks associated with this tool.

Source:

http://www.cbsnews.com/news/doctor-with-cancer-morcellator-medical-device/

Posted Under: Blog