What manufacturer Johnson & Johnson (J&J) knew about the safety of its morcellators and when is the subject of an investigation by the Federal Bureau of Investigation (FBI), according to several news reports. Coverage by The Wall Street Journal and The New York Times cites interviews with several individuals who spoke to the FBI as part of the probe but both accounts indicate that the agency itself refused to comment.
The FBI, it appears from the interviews, is attempting to determine whether J&J knew more about possible hazards of power morcellation than it reported before taking its device off the market. In April 2014, the Food and Drug Administration (FDA) issued a safety communication discouraging use of power morcellation during hysterectomy or myomectomy for fibroids because of concern about risk of inadvertent spread of unsuspected cancer to abdominal and pelvic cavities. Three months later, J&J removed its morcellation device from the market. The FDA estimates that approximately 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids has an unsuspected uterine sarcoma.
The actions by FDA and J&J followed a nationwide campaign to ban morcellation, led by a patient with an unsuspected sarcoma who underwent the procedure and whose disease spread. She, her husband, and a pathologist who was not involved in her case have been interviewed by the FBI, according to The New York Times account. The Wall Street Journal said that J&J has acknowledged correspondence with the pathologist, and that “his concerns spurred the company to revise its instructions for the [morcellation] device.” The patient’s husband reportedly contacted an FBI agent because he “suspected that morcellator manufacturers and some doctors and hospitals using the devices had violated a federal law requiring that adverse events be reported to the FDA,” said The New York Times report.