Republican Rep. Michael Fitzpatrick of Pennsylvania is seeking a criminal inquiry into deaths associated with the use of power morcellation devices, a surgical tool that can allegedly spread cancer in women when uterine fibroids are removed or hysterectomies are performed.
On Dec. 18, 2015, Fitzpatrick sent a letter to George Karavetsos, head of the Office of Criminal Investigations at the Food and Drug Administration (FDA), requesting that the federal agency investigate alleged power morcellator cancer deaths at Brigham and Women’s Hospital, Rochester General Hospital, and University of Rochester Medical Center.
Fitzpatrick’s letter raises concerns about deaths of four women who underwent minimally invasive gynecological surgery including the removal of fibroids. In each case, there was undiagnosed cancer that was “upstaged and spread” by the morcellation procedure, which led to each woman’s death.
The lawmaker also questioned whether the power morcellator cancer deaths were properly reported to the FDA, noting that under Medical Device Reporting Regulations, hospitals must report to the FDA within 10 days information that “reasonably suggests that a device has or may have caused or contributed to the death of a patient in …[a given] … facility.”
Additionally, Fitzpatrick is asking for an investigation of the most prominent maker of morcellation devices, Ethicon, a subsidiary of Johnson & Johnson.
The hospitals named in the letter have released statements that they did not violate FDA regulations.
FDA: Morcellators Could Spread Cancer
A power morcellator uses small rotating blades to cut up uterine fibroid tumors into small pieces, allowing the growths to be removed laparoscopically through small incisions in the abdomen. Unfortunately, many women undergoing surgery via power morcellation were unaware that the medical device could spray undetected cancer cells throughout their bodies.
Because of the substantial risk of harm to female patients, the FDA has cautioned that power morcellators should not be used in most hysterectomy and myomectomy procedures.
The federal agency now believes that power morcellators could spread cancer in as many as one-in-352 cases. However, some gynecologists apparently disagree, insisting that the devices are safe when proper patient selection criteria is followed.
Still, the devices have become so controversial that the chief morcellator manufacturer Ethicon announced that they were halting all sales of their morcellator devices in 2014.
Power Morcellator Lawsuits
As the link between power morcellator use and advanced stage cancer becomes better understood, victims are coming forward.
All morcellator lawsuits related to the spread of cancer have been centralized in a Kansas federal court under U.S. District Judge Kathryn H. Vratil as part of a multidistrict litigation (MDL). More power morcellator cancer lawsuits are expected to be filed against Ethicon and a half dozen other manufacturers.
If you or a loved one developed cancer after undergoing morcellation surgery, you may be eligible to file a power morcellator lawsuit or a wrongful death lawsuit against the device manufacturer.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.
- First Name*
- Last Name*
- Street Address
- Apt. #
- Zip Code*
- Phone*
- Email*
- Approximately how long ago did you/your loved one have surgery to remove uterine fibroids?*
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Less than 1 year
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1-2 years
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2-3 years
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3-5 years
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5+ years
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- What were you/your loved one diagnosed with?*
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Uterine cancer
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Endometrial cancer
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Ovarian sarcomas/cancer
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Parasitic myomas
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Leiomyomatosis
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Endometriosis
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Adenomyosis
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Fibroid/uterine tissue growth on other organs requiring surgery
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No diagnosis/injury
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Other cancer (please specify in additional information box below)
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- What year were you/your loved one diagnosed?
- ¿Necesita un orador español?
- Yes
- No
- Additional Comments:
- I understand and agree that submitting this form does not create an attorney-client relationship and that the information I submit is not confidential or privileged and may be shared.*
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Yes
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