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WSJ:  A Medical Device Is Sidelined, but Too Late for One Woman

New Scrutiny Over Morcellator Tool Used in Hysterectomies May Save Lives, but Some Women Pay Grim Price for Decisions Made Before Alarms Rang

Mrs. Interlichia suffered sudden and unexpected heavy pelvic bleeding.  To her relief, her gynecologist, Wendy Dwyer, linked the bleeding to benign uterine growths, she said, and offered an enticing solution, a brochure extolling a robot-assisted hysterectomy through tiny incisions.

“She said I’d be up and running—she knew I liked to jog—in three weeks with minimal scarring and pain,” she said. “I left thinking I didn’t have a care in the world.”

But her problem wasn’t benign. It was an aggressive cancer, leiomyosarcoma, identified only after her surgery. And Dr. Dwyer had used a laparoscopic power morcellator, a tool inserted through an incision to cut up and remove the uterus.

A morcellator can leave behind bits of malignant tissue that seed multiple new tumors, scientists say. No one told Mrs. Interlichia her October 2013 surgery would use a morcellator, she said. Eight weeks later, another doctor found a softball-size mass and other tumors in her pelvis that he said weren’t there before her hysterectomy.

Mrs. Interlichia lay in her hospital bed, gripping her husband’s hand as she listened to Dr. Awtrey explain the morcellator and describe her tumors. Fragments left behind had embedded in her abdomen and grown wildly, he concluded. “That tumor, once morcellated, appeared to be like a small fire with gasoline on it,” he told the Journal.

Dozens of cases have come to light this year of women whose cancers rapidly worsened after morcellation. The U.S. Food and Drug Administration warned in April that the tools can worsen cancer. The top U.S. morcellator maker, Johnson & Johnson , halted sales in April, and many hospitals have curtailed their use.

In April, she was shocked to read a Wall Street Journal page-one article showing there had been years of scattered but accumulating evidence of the morcellator’s risk. 

Days later, the FDA issued its advisory. That was some comfort, but Mrs. Interlichia was troubled to read of a divide in gynecology: Some doctors were still using the device, insisting the FDA had overreached.

http://online.wsj.com/articles/a-medical-device-is-sidelined-but-too-late-for-one-woman-1416600067

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