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FDA Warns Patients About Uterine Fibroid Treatment Procedure

Usually when we think about the risks of surgery, we think about direct risks like surgical error or medical malpractice resulting in postoperative infections or complications. Unfortunately, that is not the only kind of risk one needs to consider when deciding whether to undergo a procedure. Unfortunately patients also need to consider whether and to what extent undergoing the procedure may increase their risk of other health problems in the future. The Food and Drug Administration (FDA) is currently warning against one such risk.

FDA Warns that Surgical Technique Increases Cancer Risk

WebMD News from Health Day reports that undergoing a surgery used for uterine fibroid treatment could increase a woman’s risk of getting cancer. It is called “laparoscopic power morcellation,” and it is often used during a hysterectomy or to remove uterine fibroids. The technique involves grinding up uterine growths and removing them through tiny incisions, or in a hysterectomy grinding up the uterus itself. It increases the cancer risk by inadvertently spreading cancerous tissue from a woman’s uterus to other body parts. About out of every 350 women who are candidates for the procedure already have a type of cancer called uterine sarcoma. If the procedure is performed on those women, the cancer can spread throughout the abdomen and pelvis. Roughly 60,000 of the procedures are done each year.

The plus side to the procedure is that it is minimally invasive. But it is not the only option. Women needing a hysterectomy or fibroid removal can undergo a different type of laparoscopic surgery that does not use the power morcellator. Traditional surgical techniques are also an option. However, both of these options come with their own set of risks, so a woman who needs treatment for these conditions should speak with her doctor about all of the possible risks and decide which risks are most acceptable for her.

Doctors Knew About the Risk

Perhaps the most disturbing part of the story is that doctors have known about the increased cancer risk since the power morcellator came to market in the 1990s. The medical community was just unaware as to how high the risk was. However, some doctors have taken steps to make patients better informed. For example, Brigham and Women’s Hospital in Boston tells patients about in-house research that shows a ninefold higher rate of unexpected uterine sarcoma in the medical records of 1,000 women who received the treatment. The Cleveland Clinic has also started warning patients about the severity of the risk.

Detecting the Cancer is Not Possible

The actual document released by the FDA on the matter is what it calls a “safety communication notice,” according to the agency’s news release. The release answers what seems like an obvious question: why not just screen women for the sarcomas before doing the procedure? According to the release, “there is no reliable way to determine if a uterine fibroid is cancerous prior to removal.” So unfortunately mitigating the risk is nearly impossible.

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