Thousands of women who underwent fibroid removal surgery or hysterectomies are suffering from late-stage cancer from a device used in their surgeries. Now, device manufacturers are facing liability as these women and their families file suit. Our team of uterine and ovarian cancer lawyers is constantly updating our clients as soon as new information becomes available.
The device at issue is called a power morcellator, which many top American hospitals and health insurance companies have now banned. These bans were based largely on FDA warnings on the use of power morcellators in gynecological procedures, confirming that they may spread undiagnosed uterine tumors and should not be used on most women.
HCA Holdings, Aetna, and several other insurers and hospitals have dropped use of the device. Aetna is the country's third-largest insurer, with about 23 million health members. Power morcellation will no longer be covered under most circumstances; doctors will have to get prior approval for any procedure using the device. Exceptions include women who could suffer severe, life-threatening complications from alternative methods.
Power morcellators work to remove fibroids or the uterus by cutting them into tiny pieces to be removed through minimally-invasive incisions. However, uterine fibroids can contain cancerous cells and tumors that cannot be detected prior to surgery. If a power morcellator breaks up a fibroid that contains cancer cells, the cancer is then spread throughout the uterus, abdomen and pelvis.
Cancer spread significantly lowers the chance of survival, rendering an otherwise benign cancer contained within the uterus into a ravenous late-stage illness affecting multiple organs. The FDA estimates that about one in every 350 women undergoing fibroid surgery has cancer cells hidden in fibroids.
After this came to light in 2014 Johnson & Johnson pulled its power morcellators from global markets. Although J&J was the largest morcellator manufacturer, other companies have kept their devices on market. One of these companies, Olympus America, was recently hit with lawsuits by women who developed cancer from morcellation surgery.
The women claim Olympus should have been aware of the cancer risks of its device, the PKS PlasmaSORD Bipolar Morcellator. They argue there was medical evidence available to Olympus, yet the company failed to respond to published studies and reports describing the risk of spreading and worsening cancer with morcellator use.
Plaintiffs point to articles published in medical journals in the 1990s that illuminate the potential for morcellators to spread cancer tissue. They argue that Olympus made it difficult for patients to know about these risks, misrepresenting the device as totally safe. Misrepresenting the device this way prevented doctors from screening for and diagnosing cancer, further worsening patient survival rates.
Still, some doctors continue to encourage the continued use of morcellators. Many doctors believe that the decision to use a morcellator should lie with the patient and her doctor and that banning them completely would be a disservice to certain patients.
This, on paper, seems a fair and reasonable argument. In reality, however, patients are not always fully informed on the true risks of their options and doctors do not always have time to make sure women completely understand the procedure, its alternatives, and their unique risks versus benefits.