FDA Warns Routine Fibroid Surgery May Spread Hidden Cancer
LOS ANGELES (CBSLA.com) — The Food and Drug Administration has issued an alert that a routine procedure to treat fibroids may cause the spread of cancer.
Power morcellation, a procedure used to mince tissue so it can be removed through a tiny incision, is often used in hysterectomies and to remove fibroids, or tumors in and around the uterus.
It's a widely-used technique, which leaves many women who've underwent hysterectomies or myomectomy (fibroid surgery) wondering whether they're now at a higher cancer risk.
According to the FDA:
"Based on an analysis of currently available data, the FDA has determined that approximately one in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma (leiomyosarcoma). If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival."
The FDA will hold hearings in July to consider an outright ban on the procedure.
Fibroids, which can cause severe bleeding and debilitating pain, can happen to women at any age but tend to cause the most trouble after 35.
"Fibroids are one of the most common reasons for a hysterectomy," Gynecologist Marc Winter said.
The doctor says technology has made fibroid surgery a lot easier than it used to be. The procedure is laparoscopic, or robot-assisted, "resulting in incisions you virtually cannot see." Winter says tumors the size of an apple can be removed through openings no bigger than a belly button.
CBS2/KCAL9 health reporter Lisa Sigell spoke with several Southland women who've underwent the procedure but haven't filed lawsuits because their doctors followed "accepted guildelines" when they performed their morcellations.
Danusia Taber, of Newbury Park, was an active mountain biker who had a long history of painful fibroids. She underwent morcellation in 2011 and went home the same day.
Five days later, her gynecologist phoned to say her pathological report showed she had a hidden cancer called leiomyosarcoma, which could have been spread by the surgery.
The cancer eventually took Taber's life.
"It happened to me," according to a South Bay fibroid sufferer who asked she only be identified as "Sandy."
"I've been shaken and stirred for life," said Sandy who underwent the same surgery for fibroids two years ago.
Within days of her surgery she also got a call from her doctor telling her she had cancer.
When surgeons know they're dealing with cancer they try to remove it in one piece, it prevents cells from escaping from a primary tumor and sprouting new tumors wherever they land.
Critics allege morcellation is dangerous because it could send potentially cancerous cells flying through the abdomen.
Anesthesiologist Amy Reed and her husband, a surgeon, have started a procedure urging the FDA to ban morcellation.
Dr. Reed underwent the procedure in October and within days of her surgery she too learned that she had leiomyosarcoma.
"Because of the morcellation, and the way this surgery was done, I now am termed stage 4, meaning they disseminated it. They spread it throughout my abdominal cavity," Reed said. "I think we could definitely take morcellators off the shelves."
The American College of Obstetricians and Gynecologists says morcellation is an option that should be available.
But there are hundreds of women coming forward as a result of Reed's petition, which prompted the FDA to issue a safety alert discouraging power morcellation.
The FDA says "There is no reliable way to determine if a uterine fibroid is cancerous before removal," and "there is a risk the procedure will spread the cancerous tissue."
Without morcellation, doctors say fibroid surgery scars will get bigger and hospital recoveries will take longer.
Looking back, Sandy says she would have taken all of that: "I would rather have sat out four to six weeks of my life than the trauma I've had to endure. I'm lucky to be alive."
The FDA alert came too late for Danusia, Amy and Sandy, but Danusia's husband, Don, hopes her story will encourage women to think twice before getting the procedure done.
Taber said, "Gynecologists will tell them that no, fibroids aren't cancer, and most of the time that's true. But it's by no means always true, and the consequences are disastrous when it's not."
More information:
- Dr. Amy Reed's petition to ban morcellation can be found here.
- Gynecologist Mark Winter, M.D. says he has never seen leiomyosarcoma in the hundreds of patients he's treated for fibroids, but since the FDA alert has been issued, he is offering fibroid patients open myomectomy or hysterectomy through an abdominal incision, or minimally invasive surgery with morcellation performed in an enclosed bag. You can reach Dr. Winter at Orange Coast Women's Medical Group here.
- The FDA alert on Morcellation can be found here.
- On May 9, the American College of Obstectricians and Gynecologists released a new report on morcellation and hidden cancer. You can read the entire report here.
*Produced by Gerri Shaftel Constant, CBS2/KCAL9 Medical Producer.