The Food and Drug Administration (FDA) recently issued a notification that the federal agency will be changing the way it informs the public on potential safety issues surrounding the use of medical devices, including power morcellators.

In the release provided by the FDA, the federal agency announced that it will now notify the public earlier than in past years regarding potential safety issues with regard to medical devices that the agency is in the process of monitoring or analyzing, such as power morcellators.

Dubbed “emerging signals,” this term refers to new information that the FDA has gathered about a medical device used in clinical practice:

• That the FDA is monitoring or analyzing
• That has the potential to impact patient management decisions and/or alter the known benefit-risk profile of the device
• That has not yet been fully validated or confirmed
• For which the agency does not yet have specific recommendations

This proposed revised public notification on device safety will serve to increase the knowledge that physicians and patient can use to make informed treatment decisions and to increase patient safety.

Laparoscopic Power Morcellation

A power morcellator is one such device that has come under scrutiny in recent years for the numerous allegations made against its safety.  A power morcellator is a surgical tool used during a laparoscopic surgery (also referred to as a non-invasive surgery) in gynecological operations.

Laparoscopic power morcellation is used during laparoscopic hysterectomy as well as uterine fibroid removal surgery.

In a laparoscopic surgery, a small incision is made and the power morcellator is inserted into the opening.  The device is used to break up tissue into small pieces and allow the small fragments of tissue to be removed though the small incision.  Overall, the risk of a laparoscopic surgery is less because of the smaller incision and reduced recovery time.

During a traditional hysterectomy, for example, the whole uterus is usually removed via an incision in the lower abdomen.  Recovery time is typically 6-8 weeks.  In a laparoscopic surgery, the incision is much smaller and the total recovery time is about two weeks.

While that seems to put a laparoscopic hysterectomy in a more favorable light, there are unforeseen circumstances that many women were faced with following a laparoscopic power morcellation surgery that left them with a new, even more frightening condition.

Morcellation and Cancer

The use of a power morcellator has been linked with a risk for spreading undetected uterine cancer.  When the morcellator is used to break up tissue, sometimes it agitates latent cancer cells.  When these cells are disturbed by the morcellator, they can be spread throughout the uterine cavity, leading to uterine cancer.

Uterine cancer is a very aggressive cancer with a poor prognosis.  As a result of the morcellator’s risk, the medical device carries the highest level warning from the FDA called a black box warning.  The FDA estimates that 1 in 350 women have a latent cancer risk and for those women, the morcellator’s action can cause uterine cancer.

Power Morcellation Lawsuit Information

If you or a loved one were diagnosed with uterine cancer following a laparoscopic hysterectomy, uterine fibroid removal or other surgery using laparoscopic power morcellation, you may be entitled to legal compensation.  An experienced attorney is available to review your case for free and discuss your legal options.