The FDA’s Obstetrics and Gynecology Devices Panel has scheduled a hearing in July to discuss whether to ban power morcellators. According to the FDA, the agency has only banned a medical device once before.
Morcellation is sometimes used in minimally invasive laparoscopic hysterectomy operations to remove the uterus and/or fibroids that can cause pain, bleeding and other complications. Hysterectomy is the most common non-pregnancy-related operation performed on women and power morcellators are used in an estimated 100,000 hysterectomies every year. The procedure involves cutting up tissue while it is still in the body and is often associated with a power tool.
It is suggested that the process of morcellation can spread undetected cancer. The procedure has been blamed for deaths of many women who had cancer that they were unaware of prior to surgery. In April, the FDA sent out a news release discouraging use of laparoscopic power morcellation for removal of the uterus or uterine fibroids for its risk of spreading undetected cancerous tissue. It is estimated that 1 in every 350 women undergoing the procedure have a hidden cancer that is worsened and can be spread by the power tool.
Johnson & Johnson, by far the largest U.S. manufacturer of power morcellators, halted sales of the devices in response to the FDA warnings and is awaiting further guidance. A series of emails and letters show the products manufacturer was made aware of the devices’ potential to spread deadly forms of cancer in 2006, eight years before it halted distribution.
Lopez McHugh is reviewing power morcellator lawsuits on behalf of patients who were diagnosed with stage III or higher uterine cancer after undergoing the procedure. If you or someone you love has been injured from the use of a morcellator during a hysterectomy or other procedure, you may be eligible to recover damages. Please contact a Lopez McHugh injury attorney for a FREE consultation with a qualified and trusted attorney who can answer your questions and ensure your legal rights are protected.