In 1993, the first electric power morcellator was approved for use in the United States. This new medical device allowed large amounts of tissue to be divided up while still inside a patient. Thus, surgeons could use minimally invasive surgical techniques to perform hysterectomies, fibroid removals, and other surgeries. Surgical recovery time was reduced, but for some patients it came at a very high price as some patients were later diagnosed with cancer due to the dangerous medical device used during their surgery.
Accordingly, in recent years concerns about the safety of power morcellators have been raised. The U.S. Food and Drug Administration (FDA), which regulates medical devices, has issued significant safety communications for doctors and patients. Additionally, the Johnson & Johnson subsidiary, Ethicon—one of the largest manufacturers of power morcellators—has voluntarily recalled all of its power morcellators from hospitals around the world.
FDA Issues Warning About Power Morcellators
The first FDA safety communication about power morcellators came in April 2014. At the time, the FDA…
- Warned that power morcellators could spread unsuspected cancerous tissue beyond the uterus when these devices were used for fibroid removal or hysterectomies. According to the FDA, while most uterine fibroids are benign, approximately one in 350 women having a hysterectomy or fibroid removal surgery has uterine sarcoma—a form of cancer—and does not know it. For these women, power morcellators can allow the cancer to spread and significantly reduce their life expectancies.
- Discouraged the use of power morcellators during hysterectomies or the removal of uterine fibroids because there is no reliable method for predicting which women with fibroids have uterine sarcoma.
- Asked healthcare providers to consider other treatments and to thoroughly discuss the benefits and risks of treatment with their patients.
- Encouraged women to discuss these issues with their health care providers, to find out if power morcellators were used during their surgeries, and to get follow-up care.
- Instructed power morcellator manufacturers to review their labeling.
Additionally, everyone was encouraged to continue reporting adverse effects to the FDA.
In November 2014, the FDA updated its safety communication on power morcellators. At that time, the FDA warned that…
- The majority of women undergoing a myomectomy or hysterectomy should not have laparoscopic power morcellator surgery.
- A strong warning should be provided about the risk of spreading unsuspected cancer.
- Doctors should share information about this risk directly with patients.
- Manufacturers of power morcellators should include new information, in the form of a boxed warning, on their product labels.
However, as of June 2015, the FDA has not issued a recall of all power morcellators and some may still be being used in U.S. hospitals.
Johnson & Johnson Has Issued a Recall For Their Morcellator Devices
In April 2014, Ethicon—the Johnson & Johnson division that made power morcellators—issued a global suspension of its power morcellators. Then, in July 2014, Ethicon issued a voluntary worldwide recall of all Ethicon power morcellators remaining on the market, including the:
- Gynecare Morcellex
- Gynecare X-Tract
- Morcellex Sigma
Ethicon sent a letter dated July 30, 2014, to hospitals and asked that specific devices be returned.
Other Actions Being Taken to Protect Women During Minimally Invasive Surgery
In May 2015, the Federal Bureau of Investigation (FBI) allegedly began looking into whether medical device manufacturers, doctors, and hospitals broke the law by failing to report problems with power morcellators.
Additionally, individuals who developed cancer after a power morcellator was used during a hysterectomy or fibroid removal have filed lawsuits. These lawsuits allege that the device manufacturers knew, or should have known, about the risks associated with the power morcellators and that they failed to inform doctors and patients of those risks.
If you have developed cancer after a hysterectomy or myomectomy performed with a power morcellator then you may also be able to take action. Please start a live chat with us now to learn more.