Power Morcellator Use Declines Following FDA Warning
Posted by PKSD Law Firm on September 9, 2016 in Defective Medical Devices
The use of power morcellators has significantly decreased following a 2014 Food and Drug Administration (FDA) warning that the devices can cause the spread of cancerous cells throughout the abdomen.
Power morcellators have been in use since the 1990s and are commonly used in minimally invasive surgeries such as hysterectomies and removal of uterine fibroids. Surgeons are able to insert the device into the abdomen through a small incision, which helps decrease recovery time. Once in the abdomen, the device shreds large masses of tissue that is removed through the small incision.
In 2014, the FDA issued a warning that the shredding technique of power morcellators has the potential to spread undetected cancerous cells within the abdominal cavity. This can worsen the patient’s cancer, making it more difficult to treat.
Since the FDA warning was issued, the largest power morcellator manufacturer Ethicon, owned by Johnson & Johnson, has pulled its product off the market. Many health insurance providers no longer cover the minimally invasive hysterectomy procedure which utilizes the device.
In 2013, power morcellators were used in 14 percent of minimally invasive hysterectomy surgeries. By 2015, the device was utilized in only three percent of these surgeries.
Experts feared that the FDA warning would cause the hysterectomy complication rate to rise, as more women would be undergoing traditional open hysterectomies instead.
However, according to research released last month in the Journal of the American Medical Association, the complication rate remains unchanged.
The rate of women who are discovered to have uterine cancer following power morcellator surgery also remained unchanged following the FDA’s warning. Approximately one in 350 women are at risk of hidden cancer being spread by a power morcellator, according to the FDA.
Women who have been diagnosed with cancer after undergoing surgery in which a power morcellator was used, may be entitled to compensation. The power morcellator lawyers at PKSD can help you fight for the justice and compensation you deserve. Contact us today for a free consultation to learn more.