Power Morcellators were developed to remove large amounts of tissue during a laparoscopic type surgery. It is a surgical instrument that minces or “morcellates” the large tissue into smaller bits that can be easily removed through a small incision.
Power morcellators have been in use since 1993 and have been used for thousands of hysterectomies. They were designed to perform hysterectomy and uterine fibroid removal through a minimally invasive laparoscopic procedure. When power morcellators mince or morcellates the tissue, cells from the morcellated tissue may be spread throughout the abdominal cavity. The use of power morcellators has been linked to the spread of a rare, malignant type of cancer that is often fatal.
Ethicon, a subsidiary of Johnson & Johnson is the manufacturer of a line of power morcellators marketed for the women’s health field is currently the subject of a number of lawsuits regarding cancer in female patients following hysterectomy with a power morcellator.
Johnson & Johnson, the parent company of Ethicon is the largest medical products manufacturer in the world and has estimated yearly revenue of over $71 billion.
Ethicon and several other manufacturers of power morcellators have been accused of failure to adequately warn patients and healthcare professionals of the dangers of power morcellator use and the increased risk of development of rare uterine cancer including leiomyosarcoma which is often fatal.
A safety alert was issued by the Food and Drug Administration (FDA) in April of 2014 which discouraged health professionals from using power morcellators in fibroid removal and hysterectomy. Ethicon has withdrawn their line of power morcellators from US sales and has issued a voluntary recall of the machines; however it is not known how many may be still in use.
Cancer is caused by an uncontrolled cellular division process that results in development of a tumor. Uterine cancer is the number four cause of cancer in women and approximately 95 percent of those cancers are endometrial. Endometrial cancer is a cancer of the lining of the uterus and has survival rates of 80 percent at five years, if the cancer is treated while still in the uterus. The remaining five percent of uterine cancers are sarcomas, or cancers of the musculature of the uterus. They are much more difficult to treat and the risk of death goes up dramatically if the cancer spreads. Power morcellator use has been shown to spread uterine cancer.
A leiomyosarcoma is a soft-tissue cancer that develops from smooth muscle cells located in the uterus or gastrointestinal tract. It is a very aggressive type of cancer and uterine leiomyosarcoma is most common in women ages 40 to 60. Uterine leiomyosarcoma accounts for only 1 percent of uterine cancer cases but is metastatic (spreading). Nearly 70 percent of women with the cancer will see a recurrence or regrowth of the cancer within 8 to 16 months after treatment, even if the cancer is removed surgically or treated while still in the uterus. Localized cancer, or cancer that has not metastasized is classified as Stage I or II and has a 5 year survival rate of 50 percent.
When a cancer metastasizes, it infects another organ such as the ovaries, liver or lungs. Metastasized leiomyosarcoma is classified as Stage III or IV and has a much higher fatality rate of 4 to 16 percent at 5 years.
Use of a power morcellator will dramatically increase the chance of metastasis as cancer cells have been spread throughout the area. Each place that a single cancer cell attaches can form a new cancer on a different organ. According to the FDA, nearly 1 in 350 women who undergo power morcellation myomectomy procedures may suffer uterine sarcoma after the procedure.
Increased risks for uterine cancer including Leiomyosarcoma are:
- Age greater than 60
- Use of anti-breast cancer medication such as tamoxifen
- African-American heritage
- Previous cancer such as childhood retinoblastoma or cancer requiring pelvic irradiation
Leiomyoma is a benign tumor which often makes up fibroid tumors. It is not malignant but rupture of the leiomyoma may spread cells which begin to grow on other tissue. Diffuse leiomyoma is not treatable with surgery and can cause significant pain. Leiomyosarcoma may closely resemble the less deadly leiomyoma or the cancer may be obscured by the fibroid mass making the use of a power morcellator that much riskier in spreading a previously unidentified cancer.
Uterine Cancer Surgery
Women who have fibroids or uterine enlargement will have cancer screening before removal to identify any cancer types that may be present. Though most cancers are identified, leiomyosarcoma is often missed as it closely resembles the non-cancerous fibroid mass. Leiomyosarcoma is not often diagnosed until after the mass is removed and examined by a pathologist.
Johnson & Johnson and its subsidiary, Ethicon, along with other manufacturers of power morcellators are facing several lawsuits for failure to warn patients. Documents show that Johnson & Johnson had been warned about the increased risks by at least one surgeon years prior to the recall but have been accused of not acting appropriately to prevent harm to patients.
At least three lawsuits have been filed in the US regarding power morcellator use in Florida, Pennsylvania and New York. Additional lawsuits are expected against Ethicon, Johnson & Johnson and other manufacturers.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.