Power Morcellator Investigation Challenges FDA Approval of Dangerous Device

October 23, 2015

U.S. lawmakers are planning to launch an investigation into the FDA regulation of power morcellators. The U.S. Government Accountability Office has agreed to probe into FDA oversight of power morcellators. Although the GAO does not comment on ongoing investigations, it could take some time to complete the probe. Less than a year ago, the FDA stepped up its oversight of the surgical devices, due to the risk of previously undetected cancers spreading, such as uterine sarcoma following uterine surgeries. The investigation is leading some changes in the healthcare industry, such as private health insurers, such as Aetna dropping coverage for any surgeries using power morcellation.

Legal Commentary
The Food and Drug Administration determined that power morcellators cannot be made safer. Johnson & Johnson, previously the largest manufacturer of morcellators, has pulled their version of the device from the market. Many hospitals are no longer using the device in hysterectomies. Currently, more than 20 lawsuits against the manufacturers of the device have been filed in 16 different federal courts. Additionally more than 300 cases against the manufacturers of power morcellators are currently pending.
Previously undiagnosed cancer or malignancies can spread after surgical procedures using power morcellators. According to the FDA, as many as 1 in 350 women could have undiagnosed uterine sarcoma that can be spread during morcellation. For patients, this can be a costly, painful and potentially deadly complication. Our firm represents families who are the victims of the complications from a variety of surgical tools, including the power morcellator. If you or a loved one has experienced any of these problems following surgery involving the use of the power morcellator, we encourage you to consult with one of our attorneys as soon as possible. A successful civil claim will help compensate the victims for the costly medical expenses, their pain, suffering, and lost wages for time missed from work. Further questions can be directed to the Fears | Nachawati Law Firm through our website at cases.fnlawfirm.com/morcellation, by emailing Majed Nachawati at mn@fnlawfirm.com, or by calling our office at +1.866.485.6886.
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