Letter to the FDA Addresses Risks of Power Morcellator Cancer
December 29th, 2015|
Controversy continues to swirl around the use of a device known as the power morcellator to remove uterine fibroids from the bodies of women.
In 2014, the U.S. Food and Drug Administration (FDA) ordered doctors and surgeons to discontinue the use of the power morcellator when performing procedures like hysterectomies due to an increased risk of the patient developing cancer. Research linked the disease to the device after it was discovered that dormant cancerous cells could be released into the body by the device, which led to several power morcellator cancer lawsuits being filed.
Doctors are now contesting these claims, saying the FDA relied on flawed research when issuing the ruling. An article from Reuters explains the medical professionals say the studies that were used during the FDA’s decision-making process were flawed and lacked credibility. For instance, the studies included three cases where the patient developed leiomyoma, which doesn’t meet the current standards and definitions for cancer.
The doctors go on to claim that making women undergo more invasive procedures than the use of the power morcellator increases the risks for hospital-acquired infections and other surgical complications, including death.
The legal staff at Ferrer, Poirot & Wansbrough recognize the dangers the use of a defective medical product can pose to patients and our team is anxiously awaiting the FDA’s response to the claims that have recently been made regarding the use of the power morcellator during surgery.