More bad news for the laparoscopic power morcellator.
The FBI is now investigating a surgical device that’s been found to spread cancer cells in women, The Wall Street Journal reports.
This adds to a call for tightening regulations around reusable medical devices from both U.S. insurers and U.S. regulators – particularly apt since the recent UCLA superbug scare.
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The morcellator was pulled from the market last year, but investigators are examining how much Johnson & Johnson – the device’s largest manufacturer – knew about the dangers of the tool. The WSJ writes:
Over the past several months, FBI agents have interviewed a retired pathologist who alerted J&J about potential problems with morcellators in 2006, a doctor who went public after her own cancer was worsened by the tool in 2013, and a California woman who has collected names of close to 400 patients and families of patients who may have been harmed by the tool, these people said.
The probe comes after the U.S. Food and Drug Administration warned in November that morcellators shouldn’t be used on the vast majority of women.
The device’s use has been drastically cut since news of its hazards have emerged – hospitals are either discontinuing or reevaluating their use in patients.
Beforehand, however, it was used in thousands of patients with benign uterine growths and in hysterectomies – the morcellator cut up tissue so it could be extracted in a minimally invasive manner. But in the process, if that tissue were cancerous, it’d spread further within a woman’s abdomen. The WSJ continues:
The FDA warned in April 2014 that women undergoing fibroid surgery have a 1 in 350 chance of harboring dangerous uterine sarcoma that can’t be reliably detected before the operation. Morcellators can spread the malignancy and worsen the outcome, the FDA said. In November, the FDA called for a “black-box” warning—its strongest caution—on the tool.
Notably, morcellators “have always included cautions in their instructions for use about the potential spread of malignant (or suspected malignant) tissue,” J&J spokesman Matthew Johnson said in a statement to the WSJ.
