Morcellator Lawsuit – Hysterectomy and Fibroid Removal May Spread Cancer
Laparoscopic Morcellators Used in Hysterectomies or Uterine Fibroid Removal May Spread Deadly Cancer in the Body
According to the Food and Drug Administration (FDA), half a million women undergo hysterectomies each year. Approximately 50,000 of these surgeries include myomectomy, the removal of uterine fibroids. Doctors have been increasingly using morcellators in these procedures in order to allow patients to avoid open abdominal surgeries which may result in longer recoveries, more complications, and larger scars. Morcellators, which have spinning blades, are used to slice the uterus or uterine fibroids into fragments that can be removed through small laparoscopic incisions.
A recent study by doctors at Columbia University revealed that approximately one in 350 women undergoing hysterectomies have undetected sarcomas that may be spread through the abdomen and pelvis by the morcellator. Sarcomas are malignant tumors that can be difficult to detect prior to surgery and are often only diagnosed when the tissue is biopsied after the surgery. There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Moreover, other types of gynecologic cancer and precancerous tissue may be missed before surgery and spread through the body with morcellation. As a result, the FDA issued a safety communication in April 2014 discouraging doctors from using morcellators in connection with the removal of uterine fibroids after it concluded that the devices could spread previously undetected cancerous tissue inside the body and significantly reduce a patient’s chances of long-term survival.
Morcellation Marketing and Testing
There are other options for minimally invasive surgery, as researchers have determined that morcellation was used in only 16 percent of minimally invasive hysterectomies. However, there are claims that the morcellator manufacturers knew or should have known that there was an unreasonable risk associated with the use of morcellators, yet withheld important information from consumers and doctors, which may have resulted in the needless suffering of thousands of women.
Furthermore, morcellator manufacturers such as Johnson & Johnson (J&J), were able to market these laparoscopic morcellators without providing pre-market clinical safety data through the FDA’s controversial 510(k) “fast track” clearance process. This process allows manufacturers to forgo rigorous pre-market clinical testing if they can establish that their product is similar to a product already on the market.
Lawsuits Filed Against Morcellator Manufacturers
The Ethicon division of J&J, one of the largest morcellator manufacturers, has halted the world-wide sales of its morcellators, although it is still possible for doctors to use morcellators that are already in hospital inventories. A lawsuit was filed against Ethicon in March of 2014 on behalf of a 53-year-old woman who died from metatastic leiomyosarcoma less than a year after undergoing a hysterectomy that involved the use of a morcellator. The complaint alleges that Ethicon failed to warn that power morcellation could result in the spread of undiagnosed cancer outside of the uterus.
How We Can Help
The product liability lawyers at Robinson Calcagnie, Inc. are currently investigating claims on behalf of women who have been diagnosed with cancer following a hysterectomy or uterine fibroid removal procedure using a laparoscopic morcellator.
Our firm has established a reputation throughout the country as one of the nation’s leading personal injury and product liability law firms. Our attorneys have represented thousands of clients in cases involving dangerous or defective drugs or devices, and have obtained dozens of multi-million dollar settlements, verdicts and judgments.
If you or someone you know has undergone a hysterectomy or uterine fibroid removal procedure using a laparoscopic morcellator and have been diagnosed with cancer, please don’t hesitate to call our Robinson Calcagnie, Inc. attorneys at (888) 222-7777 or fill out an online form for a free case evaluation.