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FDA Approved Power Morcellators Despite Cancer Risks

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Women who undergo a hysterectomy or fibroid removal in which a power morcellator is used run the risk of spreading undiagnosed cancer throughout the rest of their body. How did this happen? Why did the FDA approve power morcellators and what did they do after learning about the cancer risks to women?

Power Morcellators Approved Without Testing

Power morcellators for gynecological use were approved by the FDA in 1995. The purpose of power morcellators were supposed to make the removal of fibroids or a hysterectomy related to fibroids less invasive. A less invasive surgery would mean less recovery time for women. However, the FDA did not require any testing to be done on these morcellators since there were similar devices on the market that were being used in other surgical capacities.

Cancer Spreading Through Use of Morcellators

Sadly, power morcellators used during hysterectomies and fibroid removal surgeries are linked to the spreading of undetected uterine and cervical cancer. Although the FDA stated in a news release that their main concern is for the “safety and well-being of patients,” one has to wonder if that’s true. It took more than 20 years before the FDA issued a warning and discouraged the use of morcellators because of the cancer risks.

Morcellators Have Not Been Recalled

It’s important to realize that while the FDA finally discouraged the use of morcellators because of cancer risks, the devices have not been recalled. Between the years of 2005 and 2010, a study of the medical records of more than 1,000 women who received treatment with a power morcellator were studied by researchers. The women received treatment at Brigham and Women’s Hospital in Boston. Those women had a substantially higher chance of developing leiomyosarcoma when compared to the usual statistic of 1 in 10,000.

Sadly, some hospitals have not totally stopped using the devices although they’ve changed how they are used. Yet, there’s still the troubling statistic that 1 woman out of 352 who undergo the procedure with a morcellator will develop cancer.

Signs of Leiomyosarcoma

Leiomyosarcoma is the medical term for uterine cancer. Morcellators are linked to the spread of cancer cells throughout the body. Uterine cancer doesn’t always have a lot of symptoms that stand out when compared with other gynecological problems. The signs of leiomyosarcoma include:

  • Abnormal bleeding, spotting, or discharge
  • Pain or difficulty when urinating
  • Pain during intercourse
  • Pain in the pelvic region

You Have Rights

If you’ve been diagnosed with fibroids or plan to undergo a hysterectomy, you have rights. One of the best possible ways to protect yourself is to ask whether they plan to use a morcellator. If they do, you have the right to ask for another method. Explain your concerns and remember that you have the right to make the decision. It can be hard to know whether your gynecological symptoms are no big deal or if they are cancerous. You can protect yourself by getting the information that you need about the surgery.

Was Your Cancer Spread by a Morcellator?

If you had a hysterectomy or fibroid removal that involved a morcellator and later found out that the device spread cancerous cells, you should contact Goldwater Law Firm. We provide free case reviews. To learn about your options, contact us today.