US GAO to Investigate Power Morcellator
The United States Government Accountability Office (GAO) recently announced it will launch an investigation into reports that laparoscopic power morcellators can cause the spread of uterine and ovarian cancer. Power morcellator devices are routinely used in hysterectomy procedures, as well as in fibroid removal procedures. The GAO investigation seeks to determine whether the devices can cause the spread of certain cancers in female patients. The investigation is set to commence in early 2016.
Most women will develop uterine fibroids in their life, but they may not have any symptoms. Some, however, will experience serious and painful complications such as pelvic pressure and heavy menstrual bleeding. When this happens, medical intervention is necessary.
Power morcellators are often used in conjunction with a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids.) These powerful devices have spinning blades that shred fibroids into tiny particles so that they can be easily removed via small incisions. Morcellators have proven to be a helpful tool in reducing scarring and diminishing recovery time for hysterectomy and myomectomy patients. Until recently, the risk of spreading cancers was never considered. An estimated 1 in 350 women has undetected sarcomas that the morcellators can shred and spread into the abdomen, leading to late-stage cancer and even death.
Morcellators appeared on the market in 1991, but their risks were not realized until 2013. The risks were much greater than gynecologists initially realized. The GAO also plans to review the FDA’s handling of consumer and physician adverse event reports. In 2014, the FDA released a safety communication to health care providers, medical facilities and patients to inform them of the involved risks.
Several power morcellators are still on the market. However, the largest manufacturer, Johnson & Johnson, voluntary took its devices off the market in 2014. Many medical facilities are now restricting morcellator use. In addition, several insurance companies are also refusing to cover power morcellator.
Many women who have suffered from late-stage cancer due to morcellator use have filed lawsuits against the manufacturers for their negligence and failure to warn them of the possible risks. If you believe that you or a loved one have a uterine power morcellator claim, contact the medical device attorneys of Nadrich & Cohen, LLP for a free consultation.