(CN) - After his wife died last month of occult cancer, a North Carolina man has filed a federal lawsuit against the makers of a medical device that he says spread tumors in her body.
Jerry Woodell notes that his wife Bethann underwent a total laparoscopic hysterectomy to remove her uterine fibroids in March 2012.
Her surgeon used a laparoscopic power morcellator, which the complaint filed on Oct. 22 in New Jersey defines as an electric-powered medical tool "with spinning blades that shred, grind, and core tissue into smaller pieces or fragments so the tissue can be removed through small incisions in the abdomen."
"During tissue morcellation, fragments can be left in the abdomino-pelvic cavity, or attach to surrounding organs, and cancerous cells can travel to remote areas of the body," the complaint states.
Within six months of that surgery, Bethann was in a hospital emergency room complaining of fatigue, migraines and symptoms often associated with a urinary tract infection.
Woodell says testing over the next few weeks revealed Bethann had large masses in her pelvis. Doctors originally thought the masses were benign but surgical pathology soon revealed high-grade leiomyosarcoma, according to the complaint.
Bethann underwent extensive chemotherapy and numerous surgeries over the next year and the half, but the masses only spread and increased in size, her husband says. She died on Sept. 9.
Woodell says the makers of the morcellator devices have long known the risk they pose to spreading "occult (i.e. hidden) cancer," but that they have refused to address the design flaws or to respond to the numerous studies and reports.
Despite this evidence, no one warned Bethann that the device used in her 2012 surgery had the potential to spread any hidden cancer, the complaint states.
With 650,000 women undergoing a surgical myomectomy or hysterectomy every year to manage uterine fibroids, Woodell says laparoscopic procedures to remove uterine fibroids "have increasingly replaced traditional open abdominal surgical hysterectomies, myomectomies, and laparotomies."
"Long before [Bethann] underwent surgery in 2012, defendants knew or should have known that their laparoscopic power morcellators could cause occult malignant tissue fragments to be disseminated and implanted in the body, which, in turn, upstages any cancer present and significantly worsens a woman's chance of survival," the complaint states.
The U.S. Food and Drug Administration announced last year that it now "warns against using laparoscopic power morcellators to treat uterine fibroids."
"The FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma," a statement on the FDA's safety communication says. "If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's likelihood of long-term survival."
Woodell's complaint takes aim at Ethicon, Johnson & Johnson, Olympus and more than a dozen other medical-device manufacturers and their affiliates.
He seeks punitive damages for negligence, wrongful death and several other claims.
Woodell is represented by Ellen Relkin with Weitz & Luxenberg in Cherry Hill, N.J.
Neither Relkin nor representatives for Johnson & Johnson have returned requests for comment.