The FDA has issues a black box safety warning against the use of laparoscopic power morcellators in gynecological surgeries due to their propensity for spreading deadly cancers in women. Laparoscopic power morcellators are a surgical tool with a rotating blade that is used primarily during hysterectomy and myoectomy to remove uterine fibroids. This medical device fragments and shreds fibroid tissue, which is then removed through a small incision.
This tool makes it possible for women to undergo a less invasive laparoscopic hysterectomy or myomectomy, eliminating the need for a longer recovery time and the risk of the higher mortality rate associated with full abdominal hysterectomy. In some cases, however, this tool is proving to cause more harm than good.
Dangers of power morcellators in gynecological surgeries
According to the U.S. Food and Drug Administration, as many as 80% of women will get uterine fibroids in their lives. Power morcellators have been used in approximately 11% of the nearly 500,000 hysterectomies and myomectomies that are performed each year in the United States, or in about 55,000 to 75,000 procedures.
In women with an unsuspected malignant uterine sarcoma embedded in the fibroid tissue, the morcellator shreds the tissue and spreads fragments of it throughout the abdomen and pelvis, resulting in significant injury.
The FDA found that 1 in 352 women undergoing a hysterectomy or myoectomy had an undetected sarcoma. These cancers can be difficult to detect preoperatively so the FDA has recommended that women with symptomatic fibroids seek alternative treatments such as the traditional surgical hysterectomy.
The FDA first approved laparoscopic power morcellators in 1995, and the devices were still manufactured and used in surgeries despite industry knowledge of its propensity to spread deadly cancer. Public knowledge of the danger first came in 2014 when the FDA issued its safety communication.
Johnson & Johnson’s subsidiary, Ethicon, halted sales in April 2014 and later issued a recall of the devices worldwide. In November of 2014 the FDA issued its black box warning against the use of power morcellators due to the cancer danger.
Lawsuits against manufacturers of power morcellators
Women who have been diagnosed with cancers after having had surgeries where the surgeon used a power morcellator have been filing lawsuits against the product manufacturers. The plaintiffs are suing for negligence and the fraudulent misrepresentation that the product is safe when it is not. Other lawsuits claim that manufacturers failed to properly warn the public about the dangers associated with the use of their product.
If you have developed gynecological cancer after having undergone surgery using a power morcellator, you may be entitled to take legal action against the manufacturer of the device. Your first step I to speak to an experienced, Mississippi products liability attorney who will listen to your story and advise you on the best course of action given the facts of your case.
The law firm of Taylor Jones Taylor wants to hear your story. Please contact us make an appointment at one of our offices in Southaven, Olive Branch or Hernando.