Florida Woman’s Case Highlights Concern about Morcellator’s Cancer Risk during Uterine Surgery By Tod Aronovitz | 06/24/14 | 0 Comment

The power morcellator, a surgical tool used to treat uterine fibroids and perform hysterectomies, has become a common device in these medical procedures because it can cut tissue into small pieces to be removed through a laparoscopic incision.

However, according to an article in a recent Top Class Actions newsletter, there is increased concern that laparoscopic power morcellation may actually cause aggressive cancers to spread.

Florida woman Peggy Paduda filed a lawsuit against Karl Storz Endoscopy-America. According to the claim, a Storz Rotocut Morcellator was used to “cut, shred and remove one or more uterine fibroids from her uterus during the surgery.”

Even though the procedure was successful, the plaintiff was unaware that she suffered from endometrial stroma sarcoma, a rare type of uterine cancer. The plaintiff contends that the use of the morcellator diverted the sarcoma outside her uterus, “spreading the cancer throughout her abdominal cavity, shortening her life-expectancy and reducing her quality of life,” the article said.

Existing data shows that one in 350 women undergoing morcellator laparoscopic hysterectomies (of the 50,000 that are estimated to be performed annually), or myomectomy (uterine fibroid removal), have uterine sarcoma. Because there is no reliable method for predicting whether a woman with uterine fibroids has a uterine sarcoma, the U.S. Food and Drug Administration has warned doctors and women, especially those with suspected or known uterine cancer, to avoid laparoscopic power morcellators.

Paduda’s lawsuit was filed only a few weeks after the FDA issued its warning about power morcellators, and she is seeking both compensatory and punitive damages from Storz for negligence, strict product liability, breach of warranty, and fraudulent misrepresentation and omission.

According to a Wall Street Journal story on June 16, “Showdown for Surgical Tool: FDA Panel Will Hear Proponents and Opponents of Uterine Device at Hearing” by Jennifer Levitz, an advisory panel will determine whether the device should be banned—a radical ruling the FDA has only made once before involving a device used in artificial hair implants.

The FDA’s Obstetrics and Gynecology Devices Panel, which will hold its hearing July 10-11 in the Washington area, will debate a variety of issues before considering whether the tool should be moved permanently off the market, the WSJ article explained.

Some arguments include a more stringent patient selection process, using alternative accepted procedures, more training for gynecologists, and exploring the use of containment bags in the body during surgery to prevent the spread of harmful tissue. Another potential move would be for the FDA to reclassify morcellators as high risk instead of moderate risk, which would require manufacturers to conduct trials to keep their products on the market, and something manufacturers may determine is not worth the cost.

While the FDA isn’t obligated to follow the advice of the panel, it factors in heavily in its decision on what is best for the patient, according to agency spokeswoman Jennifer Rodriguez.

Johnson & Johnson is largest U.S. manufacturer of power morcellators. The company stopped sales of the product globally in April as it waits for further guidance from the FDA.

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