Morcellator LawyerNovember 19, 2015 — The FDA and Johnson & Johnson say there were no reports of morcellators upstaging or disseminating cancer before December 2013, but a retired pathologist warned about the risk in 2006, according to The Cancer Letter.

Dr. Robert Lamparter, a retired pathologist who practiced medicine for 28 years, contacted J&J after a “near-miss” involving a woman who was scheduled to have a hysterectomy.

The operation started as a morcellation, but doctors were forced to switch to open surgery due to adhesions. When her uterus was removed, doctors found cancer.

Dr. Lamparter wrote a letter to J&J recommending stronger warnings:

“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 estimates were strikingly accurate. In November 2014, the FDA warned that 1 in 350 women undergoing a hysterectomy for fibroids has undiagnosed cancer, and warned against using morcellators in the “vast majority” of women.

Dr. Lamparter said because his complaint involved a “near-miss” instead of an actual injury, J&J did not file an adverse event report with the FDA or warn the gynecological community. Instead, they added a precaution in the instruction manual. Eight years later, the company suspended sales of all morcellators due to the risk of spreading cancer.

As awareness about the problem has grown, so have the number of adverse events. The FDA has now received dozens of reports of cancer upstaging or dissemination that occurred before December 2013. As of November 2015, 27 lawsuits filed by women who were injured have been centralized in federal court.

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