A power morcellator is a medical device often used to perform laparoscopic procedures considered to be “non-invasive,” such as removal of uterine fibroids during surgeries like hysterectomies and myomectomies. These devices are inserted into the patient through small incisions on the abdominal area. The power morcellator works by entering the body through those incisions and breaking apart uterine fibroids in order to make them easier for the surgeon to remove via a suction device.
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Recently, however, physicians believe that morcellation can spread undiagnosed cancer that existed in the fibroids to other parts of the body, which can cause metastasis of the cancer. There are now several lawsuits being filed by families seeking justice from the manufacturers for not disclosing these risks to the medical community and the public.
The power morcellator grew in popularity because of minimal recovery times given the non-invasive nature of the procedure. Statistics estimate that about 11 or 12 percent of all hysterectomies use a power morcellator and there are approximately 600,000 hysterectomies performed each year.
The United States Food & Drug Administration, (or FDA,) began a formal investigation into power morcellators in 2014, which lead to a finding that up to 1 out of 350 women undergoing procedures with a power morcellator had an aggressive form of uterine cancer, known as leiomyosarcoma. This was a shocking statistic given, that prior gauges of this were 1 out of 10,000.
Since that report, the FDA has warned both physicians and surgeons using the product to avoid use of it in almost all procedures. They have also asked that all companies still producing the product increase the severity of the language on the warning label.
Now that multiple lawsuits have been filed, many women and their families are stepping forward seeking justice against the manufacturers of the power morcellator. One such family, who tragically lost their loved one, settled their lawsuit against LiNa Medical recently for an undisclosed amount. Many more lawsuits with similar allegations are pending before the courts, and in October of 2015, these cases may be consolidated by the courts into a “mutlidistrict litigation” due to the expected numbers of cases anticipated to come forward.
Recently, the FBI have begun investigating one of the largest manufacturers of the power morcellator, and members of congress have requested a specific investigation of the FDA to scrutinize the approval that the morcellator received.
“The FDA’s primary concern as we consider the continued use of these devices is the safety and well-being of the patients.” This was stated by the FDA Center for Devices and Radiological Health’s deputy director for science and chief scientist, William Maisel, M.D., M.P.H.
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laproscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals.”
“Input from clinical and scientific experts will help provide valuable information and perspectives to clarify the proper clinical role for these devices,” Maisel continued. “We anticipate the discussion will include whether a boxed warning related to the risk of cancer spread should be added to the product labeling for laparoscopic power morcellators to ensure patients and health care professionals are adequately informed of the risks.”
Just one year ago, Capital Blue Cross used their website to announce that they had witnessed what seemed to be a “significant patient safety concern” connected to power morcellator use and, from November of 2014 on, discontinued all reimbursements for procedures involving the device. Additional insurers have dropped coverage for the procedure ever since, and the list continues to grow today.
If you had a power morcellation in a hysterectomy or myomectomy, it is important that you remain vigilant and consult with your medical professional about testing to determine if your procedure caused a spreading of previously undiagnosed uterine cancer.
If you, a family member, or a loved one was diagnosed with cancer after having a myomectomy or hysterectomy procedure using a power morcellator, you may have grounds for a lawsuit and an opportunity to seek justice against the manufacturer of the tool that did this to you and your family.
If you have questions about the lawsuit or a potential claim, we encourage you to get more information from the experienced cancer misdiagnosis attorneys at Justice Guardians that has been involved in these types of litigation. Michael is a resource that you can use to get answers and clarity on your situation.