Power Morcellator Uterine Injury Lawyers
A power morcellator is a medical device used in laparoscopic surgery to remove uterine tissue or uterine fibroids. A uterine fibroid is a non-cancerous growth that forms in the wall of the uterus. These growths can sometimes cause problems for women such as pelvic pressure or pain, heavy menstrual bleeding, or frequent urination. Surgery may be necessary to relieve these symptoms. Doctors have used laparoscopic power morcellation as a means to remove these fibroids through small incisions in the woman’s abdomen with the intent to speed recovery time for the patient. Doctors have also used laparoscopic power morcellation in hysterectomy surgeries to completely remove the uterus.
The power morcellation device consists of a hollow tube that is inserted into the abdomen along with a cutting instrument and grasper that allows a surgeon to cut the tissue into many tiny pieces and extract them through the hollow tube.
Power Morcellation Injuries
The FDA issued a safety advisory in April 2014 discouraging the use of laparoscopic power morcellation during the removal of the uterus or benign uterine tumors. The FDA analyzed data and discovered 1 in 350 women undergoing such procedures have unsuspected uterine sarcomas, a type of uterine cancer. Morcellation can spread cancerous tissue around the abdomen and worsen a woman’s long-term survival rate.
Since the FDA issued its advisory, a number of manufacturers have elected to pull their devices off the market. Some insurers and hospitals have also ceased coverage and banned the use of these devices.
FDA Black Box Warning for Power Morcellators
On November 24, 2014, the FDA issued an update to its previous warnings regarding power morcellators. A black box warning informing healthcare providers and patients that:
- Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
Additionally, the FDA recommends two contraindications of the following:
- Laparoscopic power morcellators are contraindicated (should not be used) for removal of uterine tissue containing suspected fibroids in patients who are: peri or post-menopausal, or candidates for en bloc tissue removal (removing tissue intact) through the vagina or mini-laparotomy incision. (These groups of women represent the majority of women with fibroids who undergo hysterectomy and myomectomy).
- Laparoscopic power morcellators are contraindicated (should not be used) in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
Power Morcellator Lawsuit
If you have a question about a power morcellator lawsuit, contact us. Our firm is investigating claims from patients who have undergone hysterectomies or the removal of uterine fibroids via power morcellators. Our product liability attorneys have experience litigating claims against large corporations and pharmaceutical manufacturers and can provide you with a free case evaluation. Learn about your legal rights regarding compensation through a power morcellator lawsuit. Contact us now for a free case evaluation.