November 19, 2015 — A pathologist warned Johnson & Johnson about the cancer-spreading risks of morcellators in 2006, but no adverse events were submitted to the FDA until December 2013.
The Cancer Letter talked to Dr. Robert Lamparter, a pathologist with 28 years of experience. In 2006, he contacted J&J after a “near-miss” involving a woman undergoing a hysterectomy.
Doctors intended to use morcellator, but were forced to switch to open surgery due to adhesions. When her uterus was removed, she was diagnosed with cancer. In a letter to J&J, Dr. Lamparter wrote:
“If this woman had had a morcellization, her tumor would have been seeded into the peritoneum. … In about 1/300 hysterectomies at our hospital, we discover an endometrial carcinoma that was unexpected at the time of surgery. … If a morcellation is done, the patient’s survival is jeopardized.”
His risk estimate came eight years before the FDA warned that morcellators should not be used in the “vast majority” of hysterectomies because 1 in 350 women who undergo the procedure has undiagnosed cancer.
But because the event was a “near-miss” instead of an actual injury, J&J did not file a report with the FDA. Instead, the company added a warning to the instruction manual. Eight years later, J&J pulled all power morcellators off the market. As of November 2015, the company is facing 27 lawsuits from women who were injured.
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