Fibroid tumors (leiomyomas) are noncancerous growths, most often found in the uterus during a woman’s childbearing years. They’re not uncommon — as many as 3 out of 4 women develop uterine fibroids at some point, but most women don’t know they have them because fibroids often cause no symptoms. In some cases, however, they cause bleeding, bladder problems and pain, and in these situations the doctor may recommend drug therapy or surgery.
Laparoscopic techniques have become common for many types of surgeries, including fibroid removal. With laparoscopy, a surgeon is able to insert special instruments through tiny incisions rather than opening up large incisions to reach the internal organs. Many patients benefit from laparoscopic surgeries because they can leave the hospital sooner and have an easier recovery period.
Tragically, many women who have had non-cancerous fibroid tumors removed through a laparoscopic procedure have soon thereafter been diagnosed with advanced uterine cancer — a result of the power morcellator utilized during the operation.
Power morcellators are surgical tools which have been approved for gynecologic procedures since the 1990s. The FDA has estimated that doctors in the U.S. use power morcellators for removing fibroid tumors about 50,000 times each year. A morcellator consists of a handheld trigger mechanism attached to a long metal tube with blades on the end. The surgeon inserts the morcellator into the small laparoscopic incision and turns it on to chop up the fibroid tissue so the small pieces can be removed.
Here’s the problem: If a woman has cancer cells in her uterus which were not detected prior to the morcellation, they too can get shredded and spread throughout the area. This means that the malignant cells are more widely distributed than if they had been left alone, and by the time a cancer diagnosis is made (which is often just a matter of weeks), it is at a very advanced stage.
How widespread is the problem? The FDA has issued a warning that these hidden cancers are more common than were previously believed. They estimate that the prevalence of unsuspected uterine sarcoma is 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. The FDA has recently required a Black Box warning for laparoscopic power morcellators, stating that they could spread an unsuspected cancer and decrease the survival rate of patients.
Some manufacturers have taken the devices off the market. Some hospitals have banned their use. But some gynecologists and surgeons are still using them, exposing women being treated for non-cancerous fibroids to a death sentence from malignant cancer.
Numerous plaintiffs have filed lawsuits alleging that the manufacturers of the power morcellators knew of and failed to warn patients and doctors that the medical device could cause up-staging of previously undiagnosed cancer and that the companies erred in their design and testing of the tools.
Pogust Millrood is a nationally known firm focusing on helping victims of pharmaceutical and medical injuries. If you or your spouse had a laparoscopic operation for the removal of fibroid tumors and later were diagnosed with malignant cancer, call 1-888-348-6787 to schedule a confidential, no-obligation consultation with one of our product injury lawyers.