Johnson & Johnson has started taking all its power morcellator products off the market, and is asking doctors to promptly return devices they bought before the company’s sale suspension in April, according to the Washington Post.
Johnson & Johnson announced on July 30th that it would be reaching out to consumers the following day to alert them that power morcellators marketed by Ethicon were being pulled from the market, and to return them to the company as soon as possible. This action follows Johnson & Johnson’s suspension of device sales and distribution in April, after the U.S. Food and Drug Administration (FDA) advised doctors to stop using them until further safety review had been conducted. The FDA alert, which was issued on April 17, 2014, estimated that 1 in every 350 women undergoing fibroid removal surgeries had uterine sarcoma and other cancers prior to power morcellator surgery, that may only be diagnosed after fibroids are removed and biopsied.
These devices are designed for use in laparoscopic hysterectomy and fibroid removal surgeries as a means of more easily extracting uterine tissue. According to a growing number of power morcellator lawsuit filings from women who underwent the procedure, the devices can inadvertently promote the spread of uterine cancer into other parts of the abdominal cavity, which may ultimately diminish a woman’s chances of long-term survival.
Earlier this month, the FDA’s Obstetrics and Gynecology Devices Panel met to discuss whether power morcellator surgery should be banned in the U.S., or if it poses benefit to women. The meeting took place on July 10th and 11th, where women and their families candidly relayed the negative experiences they allegedly had because of the devices, according to a Boston Globe report.
The meeting ended with a lack of agreement on the issue, but panelists did all stress that morcellator patients should be required to sign documents that show they were adequately warned about the potential for the devices to spread uterine cancer prior to surgery.
Following the FDA advisory committee meeting, a study included in the Journal of the American Medical Association lent further evidence to morcellator fears. Results published on July 22nd indicate that 1 in every 368 women undergoing fibroid removal surgeries may have undiagnosed cancer. What’s more, an estimated 32 percent of morcellator patients involved in the study were younger than 50.