| The Federal Bureau of Investigation is looking into whether the medical community neglected to report potentially fatal side-effects of a hysterectomy surgical tool, according to a doctor who says he has been interviewed by the agency. Hooman Noorchashm, a thoracic surgeon who has crusaded relentlessly against the device since its use in his wife's routine hysterectomy spread her cancer, said he has been interviewed several times by agents out of the FBI's Newark office. The main manufacturer of the surgical power tool, called a morcellator, is Ethicon, the Somerville-based division of Johnson & Johnson. A spokesman for the company said it had not been contacted by the FBI. The device is a power shaver on the end of a thin tube that is inserted through a tiny incision into the uterus to mince and suction out tissue. This form of laparoscopic surgery has been popular with women because of the reduced scarring and recovery time compared to a conventional hysterectomy. The problem � which turned out to be much more common than previously realized � was that undetectable cancer cells could be splattered throughout the abdominal cavity by the device. What at the onset of surgery was a Stage 1 cancer became a Stage 4 cancer at its conclusion. The U.S. Food and Drug Administration last year issued a warning against use the device for most hysterectomies, saying the risks were simply too high. "If someone violates the law and people die because of it, is that a crime?" In response, Johnson & Johnson suspended sales of its morcellator. "In July 2014, we voluntarily withdrew all of the Ethicon devices, and Ethicon morcellation devices remain off the market. We are the only manufacturer of these devices to have taken such action," the company said in a statement. Noorchashm said he reached out to the FBI last fall, urging the agency to look into whether doctors, hospitals and manufacturers had failed to report any fatal surgical outcomes to the FDA, as the agency's regulations require. "If someone violates the law and people die because of it, is that a crime? You tell me," he said. He and his wife, who continues to battle Stage 4 leiomyosarcoma, moved from Boston back to Philadelphia last year to be near family. He is now affiliated with Thomas Jefferson University Hospital. The FBI's press office in Newark said it was the agency's policy to neither confirm nor deny the existence of any investigation. Noorchashm said the FBI had also interviewed a retired Pennsylvania pathologist who has said he became concerned about an unusual number of "upstaged" cancers. The man has said publicly that he contacted Ethicon as early as 2006 with his concerns. |
No comments:
Post a Comment
Keep a civil tongue.