It was supposed to be a significant medical breakthrough: uterine fibroid removals (myomectomies) and uterine removal (hysterectomies) requiring only a small incision (laparoscopy) rather than full-blown surgery (laparotomy).
Instead of weeks of recovery, a patent would be back to normal in mere days. But in order to reduce the size of the organs in order to remove them from the body, a surgeon would have to "morcellate" (cut into smaller pieces) the tissue.
Unfortunately, morcellation has now been linked to a previously unknown side effect in rare cases -- an increased risk of spreading cancer.
Morcellation and Cancer Risk
This may be oversimplifying things a bit, but power morcellation is the use of a power tool (a morcellator) to cut up the fibroids, and in the case of a hysterectomy, the uterus, into smaller pieces to facilitate removal. Unfortunately, in rare cases, a cancer that is not detected in routine pre-operation tests can be hiding in the cells, and the morcellation process can spread these cancer cells into the patient's pelvic and abdominal areas.
Warning: This is a graphic video of an actual operation.
The prognosis for such a patient is grim. According to a petition by Dr. Amy Reed, who is one of those patients, and her husband, Dr. Hooman Noorchashm, only 15 percent of those who have the rare cancer that has spread will be alive after five years. Those whose cancer is spread via morcellation are about four times more likely to die.
The couple's petition seeks to ban the procedure in favor of safer alternatives, such as a "bagged" morcellation (where a bag surrounds the organs, reducing the chances of spreading cancer) or a traditional open hysterectomy.
You can see an interview with Dr. Reed in this clip from Philadelphia's KYW-TV:
The FDA's Response
On April 17, 2014, the FDA issued an alert discouraging the use of power morcellation in myomectomies and hysterectomies. According to the FDA, as many as one in 350 women undergoing these procedures risks the spread of undetected uterine cancer, a rate far higher than previous estimates.
Then late last month, Johnson & Johnson, the largest manufacturer of power morcellators, suspended sales of the devices, while noting that the suspension was in order to do more research and was not a recall.
Here at FindLaw, we do our best to keep the public up to date on current recalls and any potential legal recourse for those affected by defective medical devices. Our Learn About the Law team quickly responded to the news with three articles discussing morcellators:
- Power Morcellation Recall Information, discussing the devices, the FDA, the sales suspension, and a potential recall;
- Power Morcellation FAQs, covering the risks, the suspected connection to cancer, and the legal issues; and
- Power Morcellation Lawsuit Information, addressing the FDA's alert and possible theories for potential legal action.
FindLaw Will Follow the Latest Developments
When it comes to allegedly defective and unsafe products and recalls, news can move fast.
For the power morcellator issue, FindLaw's lawyer-writers will keep consumers updated as news breaks on our Injured and Common Law blogs, while our Learn About the Law section will continue to provide valuable information and resources for those affected by defective medical products.
We also maintain a list of defective medical device lawyers, should a patient need legal assistance. Many offer free consultations (just ask!).
Stay with FindLaw for the latest developments on the power morcellator issue. If you have specific legal questions you'd like us to cover, let us know on our FindLaw for Consumers Facebook page or on Twitter (@FindLawConsumer).