Last month, the FDA and other women’s health experts warned of the dangers of undergoing laparoscopic hysterectomies and myomectomies due to the risk that morcellation surgical devices may spread undetected uterin cancer.
The news caused several top hospitals to stop performing the procedures, and J&J, who sells 75% of all morcellators in the United States, to halt sales.
Now, as a group of surgeons defends the use of morcellation, a California woman has filed the first federal lawsuit in her state against the manufacturer of the device used in her surgery, claiming it caused a spread of uterine cancer.
The FDA and Society of Gynecological Oncology have warned that as many as 1 in 350 women undergoing a hysterectomy or fibroid removal surgery may have undetected uterine sarcoma cancer, and that the disease can be severely "upstaged", or accelerated, by morcellation.
Morcellation devices allow doctors to perform minimally invasive surgeries by cutting the uterus into small pieces for removal rather than making a 5-7 inch incision in the abdomen. However, the cutting of these organs can spread tissue and cancer to other parts of the abdomen.
Cancer can be spread so quickly by morcellation that women who have the procedure accidentally are 4 times as likely to die than those who didn’t have the procedure, and their average lifespan drops to 24-36 months.
Although J&J halted sales of morcellators and hospitals like Brigham & Womens and the Cleveland Clinic stopped doing the surgeries, an association of doctors who profit from them has supported continuing the dangerous practice.
The American College of Obstetricians and Gynecologists, an influential group of surgeons, recently claimed the benefits of minimally invasive morcellation surgery outweigh the small chance of uterine cancer.
On May 13th, Sarah Salem-Robinson and her husband filed a morcellation lawsuit against Richard Wolf Medical in U.S. District Court for the Northern District of California.
Ms. Robinson underwent a hysterectomy in 2012 using a morcellator from Wolf Medical, and later learned her undetected uterine cancer had been spread throughout her entire abdomen.
The couple claim that the company failed to properly warn patients and doctors of these risks.
DrugNews urges anyone facing a hysterectomy or myomectomy to review all the risks and get a second opinion before undergoing morcellation. Also, lawyers are helping those who were diagnosed with cancer after having the procedure file claims.
Last summer, the Department of Justice unveiled the details of an ongoing lawsuit and resulting settlement against industrial giant 3M, claiming the company had furnished defective combat earplugs to millions of U.S. troops serving around the world.