Health Insurance Provider Addresses Hysterectomy with Morcellation & Cancer Risks
For many women, the stress of undergoing a uterine hysterectomy is enough to handle, and the notion of contracting deadly cancer of the reproductive organs as a result of the surgery is virtually unimaginable. However, dozens of women across the United States have endured this very result – and health insurance providers are starting to take notice.
In January, 2015, the major private insurer known as United Health issued a Network Bulletin detailing changes in its coverage allowances for non-vaginal uterine hysterectomy procedures. Citing the increasing risks of cancer in women following the use of the power morcellator device, the company opted to require prior authorization of all non-vaginal hysterectomies – which are minimally invasive and performed on an outpatient basis. Upon review, United Health has declared it will deny coverage for any non-vaginal procedures that are not medically necessary, and patients will be required to accept responsibility for the entire cost of the procedure.
The change comes on the heels of an FDA Safety Communication issued in November, 2014. The contents of that warning explained to both patients and healthcare providers that the power morcellator can spread undetected cancerous cells throughout the abdominal cavity. When this happens, undiagnosed uterine cancer cells are spread to other organs and tissue – allowing for continued growth and the development of aggressive and possibly untreatable cancer. Despite the stern warnings in the Communication, the FDA nonetheless declined to remove the power morellator from the American market, opting instead to require more disclosure on the warning label.
Basics of the power morcellation technique
A uterine hysterectomy is the surgical removal of the uterus, and over 400,000 women undergo this procedure annually. There are a number of reasons a gynecologist may prescribe a hysterectomy, including:
- Uterine fibroids
- Endometriosis
- Uterine prolapse
- Pelvic pain
- Abnormal uterine bleeding
- Uterine cancer
There are generally two ways for a gynecologist to remove the uterus: laparoscopically through the abdomen, and vaginally. In the latter, the physician accesses the uterine tissue through the vaginal cavity, while the former requires an abdominal incision. In a laparoscopic hysterectomy involving the use of a power morcellator, the uterine tissue is essentially obliterated in the pelvic region and removed in pieces. It is during this process that it becomes possible for unforeseen and undiagnosed uterine sarcoma cells to spread to other areas of the body, particularly targeting remaining reproductive organs (e.g., ovaries, cervix, or vagina). However, it is not unheard of for these malignant cells to migrate to other organ systems, requiring extensive treatment and additional surgeries in many cases.
Power morcellation litigation
A number of women have filed claims alleging they were not fully warned about hysterectomy with morcellation and risk of spreading cancer. This lack of informed consent, coupled with a resulting diagnosis of cancer, is considered by plaintiffs to be cause for legal action. Resulting power morcellator lawsuits bring claims of negligence, failure to warn and breach of warranties.
The FDA has endured increasing criticism for keeping the power morcellators on the market, despite the known correlation between use of the device and the resulting development of aggressive malignant cell growth.
- AAGL.org, Morcellation during uterine tissue extraction, http://www.aagl.org/wp-content/uploads/2014/05/Tissue_Extraction_TFR.pdf
- FDA.gov, Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm
- Sogc.org, Hysterectomy: Surgical removal of the uterus, http://sogc.org/publications/hysterectomy-surgical-removal-of-the-uterus/
- Unitedhealthcareonline.com, Network bulletin: January 2015, https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/News/January_2015_Network_Bulletin.pdf