HCA Holdings, Inc., a for-profit chain based in Nashville, Tennessee, owns about 165 hospitals and 115 surgery centers in 20 states, with about 4-5% of all inpatient care in the United States delivered at one of their facilities.
HCA already discouraged the use of morcellators after the FDA began investigating cancer risks in April. Now the company will prohibit their use altogether.
The announcement came soon after the FDA strengthened warnings for laparoscopic power morcellators and said the tool should not be used in the “vast majority” of women having fibroid surgery or a hysterectomy.
The problem is that about 1 in 350 women undergoing fibroid surgery actually has undiagnosed uterine sarcoma, but there is no way to tell whether a fibroid is actually cancer until after tissue is removed from the body and observed under a microscope by a pathologist.
While the FDA did not ban the use of morcellators in gynecological surgery, many hospitals have stopped using them — including Brigham and Women’s Hospital in Boston, where Dr. Amy Reed had a hysterectomy. Soon after that hysterectomy, Dr. Reed was diagnosed with stage-4 leiomyosarcoma.
Since last December, Dr. Reed has been the face of a high-profile campaign to ban power morcellators. When the FDA failed to ban the devices, she told Philly.com:
“I can’t begin to tell you how disappointing this is. It’s proof to me that the FDA is beholden to the manufacturers. I’d like to know what the FDA plans to say to the next patient who has an upstaged cancer. It’s an indictment of the agency.”
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