Two U.S. senators, Charles Schumer and Kirsten Gillibrand have stepped forward to request further FDA action to regulate the use of power morcellators. An article in Modern Healthcare documents the growing debate over whether to end completely or restrict the use of laparoscopic power morcellators.
The plea from the senators is for the FDA to pull all morcellator devices from the market at least until further studies are conducted. The letter cites a study at Brigham & Women’s Hospital in Boston that shows “a risk of malignant tumor dissemination nine times greater than is currently communicated to patients.”
The FDA recently began reviewing the claim that power morcellators spread cancerous tumors in women who have undiagnosed cancer. The fibroid and uterine tissues that are cut up by the device are spread throughout the internal organs of the patient and can put them at risk for far more dangerous cancer.
Less than a month ago, Johnson & Johnson called for a worldwide recall of its power morcellator device, after initially just halting new sales.
Some gynecologists argue that the FDA action is unwarranted because the device is a minimally invasive alternative to procedures that may be riskier. Lopez McHugh attorneys are experienced in handling litigation against medical device companies when products are harmful to consumers. If you or a loved one was diagnosed with cancer after undergoing a gynecological procedure with a power morcellator, you may be entitled to financial compensation. In order to obtain a free case evaluation, give us a call at (877) 737-8525 or contact us here on our website.