The Dangers of Morcellators
A morcellator is a surgical instrument that allows for the removal of large masses of tissue, while at the same time being minimally invasive. It’s commonly used in hysterectomies, uterine fibroid removal and other gynecological surgeries, however there is a concern that morcellators can spread undiagnosed cancer, and the FDA has discouraged the use of it for certain uterine procedures. Women who have found they have cancer after a morcellator procedure have filed lawsuits against device manufacturers for negligence.
Development of Uterine Cancer
According to the FDA, one in 350 women may be at risk for cancer development following a surgery in which a morcellator was used. This happens when the patient has undiagnosed cancer, which spreads after the surgery.
In 2014, the FDA discouraged doctors from using morcellators in women undergoing fibroid removals or hysterectomies because of fibroids. Uterine fibroids are benign tumors that can grow in and around the wall of the uterus or womb, however, the fear is that if there is actually undiagnosed cancer, it can easily spread due to the procedure.
Recalls and Black Box Warning
Following the FDA’s announcement in 2014, Johnson & Johnson pulled three of its morcellator devices in a worldwide voluntary market withdrawal. In the same year, the FDA recommended that morcellator manufacturers add a black box warning to the product’s packaging warning that laparoscopic power morcellators could spread cancer.
Women and their families have filed lawsuits against morcellator manufacturers alleging that patients were not properly warned of the risks and dangers of the products.
Product liability lawyers who are experienced with Big Pharma can help assess the complicated legal process of bringing a claim against a morcellator manufacturer. Contact an Arkansas morcellator attorney if you have faced health problems following a hysterectomy, fibroid removal or other uterine surgery.