Laparoscopic Power Morcellator Cancer Risk
On November 25th, 2014, the Food and Drug Administration (FDA) warned that the laparoscopic power morcellator should not be used on women during hysterectomies. The agency concluded that it believes the use of the device can spread uterine related cancers.
The agency has requested and has used its authority to call for an immediate Black Box warning for the laparoscopic power morcellators. That is the strongest warning the agency can issue.
The Deputy Director for Science of the Agency Center for Medical Devices and Radiological Health, Dr. William Maisel, has stated he believes that for the vast majority of women the procedure should not be performed.
Morcellators had been used in thousands of minimally invasive procedures every year to remove growths known as fibroids.
While most fibroids are known to be benign, they can be difficult to distinguish from uterine sarcoma which is a very dangerous type of cancer and cannot be detected before surgery in a reliable manner. A morcellator is a spinning blade to which bores through the tissue so the tissue can be removed through a small incision. Sadly, it can spread the malignancy worsen the outcome and spread cancer to adjacent and surrounding tissues.
The history of the morcellator is that it was first approved for use in the 1990s but its popularity significantly increased in the past few years with the increase of minimally invasive and robotic surgery. Newspapers began publishing articles concerning its dangers in December 2013.
It has been estimated that one in 350 women who undergo fibroid surgery which involves a hysterectomy may have a sarcoma found in later testing.
The Black Box warning is one step short of an outright ban on the device. Some doctors say the device should not be used at all. The agency is stating that the treating doctor should be very careful with patient selection for the use of the device during a fibroid procedure. The FDA believes that there is only a small amount of women who can benefit from the surgery which would outweigh the risks. These would be younger women whose fertility would be preserved by removing only the fibroids and not the uterus. In spite of that, these women should be warned of the dangers of the morcellation procedure – that unsuspected cancer can be spread. Some doctors are disagreeing because the alternative to a morcellator procedure is to open up the patient using traditional surgery.
The largest morcellator maker, Johnson & Johnson, left the market after April, 2014 (FDA) safety warning. However, other morcellators remain on the market.
A Black Box warning is unusual. There is one currently for Chantix, a smoking cessation treatment due to psychiatric side effects, Lariam, a malaria drug has one due to its psychiatric side effects, and Yaz, a birth control pill due to blood clots side effects.
We are investigating morcellator cancer cases throughout the country. We have put together a nationally renowned team of lawyers, doctors, medical experts, nurses and support staff to interview and investigate and represent morcellator victims.
If you or a loved one suffered a spread of uterine cancer as a result of morcellator use, please contact our office for a free, confidential case evaluation.
Nadrich & Cohen, LLP is a nationally-recognized defective medical device law firm and have handled many medical device cases such as this.
Please call us today at 1-800-718-4658 or complete the contact form on this page.