Women across the country who underwent gynecological surgeries utilizing power morcellators are taking legal action against the manufacturers of these devices, and further legal action against hospitals and doctors could be on the horizon. There is rapidly growing concern use of these devices can lead to the spread of aggressive forms of cancer in women not previously diagnosed with the disease.
Power morcellators are used during hysterectomies and to remove uterine fibroids. They crush tissue so the surgeon is able to easily remove it from the patient’s body in the least invasive way possible. When they hit the market, morcellators were lauded for making gynecological surgeries more effective and less risky.
Despite the benefits of power morcellators, many are finding the risk is not worth the reward.
Many women undergoing power morcellator procedures were surprised to learn the procedure triggered the spread of cancer cells throughout their body, leading to late-stage diagnoses of the disease, despite having no prior knowledge of cancer. Cancer cells that were contained in the uterus (and could have potentially been treated successfully with little risk of progression of the disease) were released into the body during the procedure, leading to aggressive growth and spread of the disease.
FDA Encouraged to Investigate Hospitals
As more and more women continue to file lawsuits against power morcellator manufacturers, one politician is calling on the FDA to investigate the use of power morcellators in regional hospitals.
Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, is asking the FDA’s Office of Criminal Investigations to look at whether three hospitals violated mandatory reporting policies in wrongful deaths related to power morcellators. The three hospitals – Brigham and Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center – have all been accused of failing to report patient fatalities related to the use of morcellators.
More Aggressive FDA Approach to Power Morcellator Incidents
Just before the end of 2015, the FDA released the “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals),” a proposal intended to provide new information for medical devices the agency is monitoring and that have the potential to cause harm.
The notification stated the FDA will notify the public earlier than it has in the past concerning potential safety issues with medical devices – specifically power morcellators. The FDA will make public information about power morcellator complications such as device malfunction, improper device use or design and other safety issues, even when the agency has yet to confirm or analyze the report.
Supporters of the more aggressive FDA action believe these early notifications will help doctors and patients understand the severity of the risks associated with morcellator procedures.
The FDA changes and call for investigation of hospitals and doctors follows an October 2015 consolidation of lawsuits in federal court against Johnson & Johnson Ethicon, makers of one of the most-used power morcellators.
Help for Women Who Experienced Complications Following Power Morcellator Procedures
If you would like more information about legal action against the manufacturers of power morcellators, or you were injured in a medical procedure that utilized a power morcellator, contact the professionals at Andrus Wagstaff law firm at 866.534.5014 or visit the firm’s website at andruswagstaff.com.
Sources:
http://www.prleap.com/pr/242570/fdas-release-talks-of-potential-safety-issues
http://fortworth.legalexaminer.com/medical-devices-implants/fda-investigates-uterine-cancer-wrongful-death-following-hysterectomy/
