Consider this situation:  You (or a loved one) have been told that you will need gynecological surgery for uterine fibroid removal or a hysterectomy. The doctor explains that there are two surgical options for the procedures and proceeds to tell you about them.

Your first option is traditional surgery that requires you to be “opened up” and has a recovery time of 6-8 weeks. Your second option is a minimally invasive (laparoscopic) surgery that requires a tiny incision and uses a tool called a power morcellator, and has a recovery time of two weeks.

Your decision would seem like a no brainer. Many women feel the same way and opt for the minimally invasive surgery assisted by a power morcellator, in hopes their recovery time will be decreased and the surgical procedure will not be as invasive or risky as a traditional surgery.

Many women may make a quick decision without even asking “What is a power morcellator?  Is it safe?”

However, a choice between the two surgical options could be a life or death decision for some women. Read on to find out how.

What is a Power Morcellator?

A power morcellator is a surgical device used in gynecological surgery applications to assist surgeons in a minimally invasive surgery. The device is inserted through a small surgical incision and has a blade that rapidly rotates to break up uterine or fibroid tissue.  The tissue is then removed from the incision.

What is a Power Morcellator Used For?

A power morcellator is used to allow patients to have surgery with a smaller incision, fewer side effects, quicker recovery, and a lower morbidity rate as compared to traditional “open” surgeries that are more invasive. The device is typically only used for hysterectomy and uterine fibroid removal.

What Does the FDA Say about the Power Morcellator?

In 2014, the FDA issued a warning against the use of power morcellators for surgeries involving fibroid removal and hysterectomy in most women. The FDA determined that a power morcellation device has the potential to spread undetected uterine sarcomas, a gynecological cancer affecting the uterus.

When the power morcellator breaks up tissue, sometimes there are cancer cells present that the patient and physician were not aware of.  Normally, the type of cancer would be fairly easy to treat, if detected.

However, when the power morcellator disturbs the tissue with the rotating blade, the undetected cancer cells can be disseminated all over the abdominal and uterine cavity.  Cancer that is spread in this manner becomes much more aggressive and more difficult to treat, leading to a much higher morbidity rate.

The FDA has recommended that manufacturers of power morcellators include a warning that acknowledges the risk that undetected cancer cells in the uterine tissue can be disturbed and unknowingly spread throughout the woman’s pelvic and abdominal cavities during morcellation.

What is the Estimated Risk of Spreading Gynecological Cancer via Morcellation?

The FDA has estimated that 1 in 352 women who undergoes surgery for hysterectomy or myomectomy (fibroid removal) has previously undetected uterine cancer.  The agency estimates that 1 in 498 has previously undetected leiomyosarcoma.

Do Other Risk Factors Contribute to a Patient’s Risk?

In a study published by JAMA Oncology in 2015, it was shown that patients who undergo a hysterectomy (as opposed to a myomectomy) have a greater risk of gynecologic cancer.

The JAMA Oncology study also showed that older age was the strongest risk factor for gynecological cancer.  Women under 30 years of age had the lowest risk estimated at 1 in 500. Older women had a greater cancer risk with women aged 75 to 79 having the greatest risk at 1 in 98.

What Has Changed Since the 2014 FDA Warning?

The lead manufacturer of power morcellators, Johnson & Johnson, removed their product from the market.  Many hospitals stopped providing power morcellation surgeries.  Many insurance companies have stopped covering procedures performed with power morcellation.

Filing a Power Morcellator Lawsuit

If you or someone you love was diagnosed with gynecological cancer following a surgery that was performed with the assistance of a power morcellator, you may have a legal claim. An experienced power morcellator attorney can review your case at no cost and can assist you in exploring your legal options.