- F.B.I. Investigates Power Morcellator Injuries
- June 25, 2015
- Law Firm: Waters Kraus LLP - Dallas Office
June 22, 2015 - The Federal Bureau of Investigation (F.B.I.) reportedly has launched an investigation into whether laws were broken by medical device manufacturers of the power morcellator device. Used in gynecologic surgery to perform hysterectomies and remove fibroid tumors, the power morcellator unfortunately has caused the spread of undetected cancers in many women.
F.B.I. Looking Into Whether Morcellator Makers, Doctor and Hospitals Ignored Law Requiring Disclosure of Adverse Events to FDA
A power morcellator has spinning rotary blades that slice a woman’s uterus into small bits which are vacuumed out of the body through a tube inserted in tiny slits made in the abdomen. But if a woman has undetected cancer, the morcellator also dices the tumor into tiny pieces which are then spun out to other areas of the body, causing the cancer to spread.
Although the F.B.I. has not confirmed the existence of an investigation, three physicians have spoken to investigators in New Jersey. One of the three is a woman who was injured by a power morcellator during a surgical procedure. An anesthesiologist, Dr. Amy Reed had undetected sarcoma at the time she underwent a hysterectomy to remove fibroid tumors in 2013. As a result of the power morcellator, her sarcoma has spread.
Dr. Reed’s husband, also a physician, contacted an F.B.I. agent because of suspicions that morcellator makers, along with some hospitals and doctors, have failed to disclose adverse evetns to the U.S. Food and Drug Administration as required by federal law.
A third physician also has spoken with the F.B.I. about his 2006 dialog with Ethicon, the Johnson & Johnson unit that sold power morcellators. Ethicon was warned back then about the risk that power morcellators could disseminate cells from undetected cancer throughout the body. Yet Johnson & Johnson waited to withdraw the dangerous medical device from the market until July 2014. In its defense, Johnson & Johnson claims that it altered morcellator instructions in response to the doctor’s concerns. The risk for women undergoing procedures with the device, however, continued.