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Johnson & Johnson has suspended worldwide sales, distribution, and promotion of their laparoscopic power morcellators this past month. This suspension comes after the FDA warned physicians and J&J that the device could be spreading deadly uterine cancer when used during hysterectomies and fibroid removal surgery. Researchers show that morcellation may worsen cancer in as many as 1 in 400 patients.
The FDA warning, which was issue on April 17 th, said that women with uterine fibroids who undergo hysterectomies or myomectomies with a laparoscopic power morcellator might be at risk for spreading and advancing a dangerous cancer, known as uterine sarcoma. Approximately 1 in 350 women who are undergoing fibroid removal actually have uterine sarcomas that are not detected until they are removed and biopsied. During the morcellator procedure, the device cuts into these sarcomas, thus spreading the cancerous tissue to other parts of the body and advancing the cancer to a more severe and aggressive stage.
Sadly, this suspension and warning comes a little too late for many women, including anesthesiologist and mother of 6, Amy Reed. In October 2013, she underwent a hysterectomy with a power morcellator for benign fibroid removal. Afterwards, it was discovered that she actually had uterine leiomyosarcoma and that the procedure spread the cancer through her abdomen and worsened her prognosis. She is currently on her 6 th round of chemotherapy and has stage 4 cancer with an 85% chance of death in 5 years.
At the moment, Johnson & Johnson’s Ethicon division is not recalling their morcellators, although safety and medical experts are urging them to do so. The Ethicon devices that have been suspended are the Gynecare Morcellex, Morcellex Sigma, and the Gynecare X-Tract.
Johnson & Johnson owns nearly 75% of the morcellator market. Other morcellator manufacturers include Karl Storz GmbH & Co., Richard Wolf Medical Instruments Corp, LiNA Medical, and Blue Endo.
In light of the new warnings, many hospitals across the country have announced that they will no longer be performing the laparoscopic procedure with morcellators.