Morcellation was thought to be an innovative treatment for women who needed fibroids removed. It was also used for women who needed a hysterectomy. The procedure was considered less invasive than more traditional fibroid removal or hysterectomy techniques. Sadly, morcellation turned out to be dangerous.
Morcellation Lawsuits Filed Because of Cancer
Around 30 morcellation lawsuits were filed by women against Johnson & Johnson related to cancer that developed after they had the morcellation procedure. In the procedure, a small incision is made. The morcellator is inserted into the uterine cavity. The morcellator grinds up the fibroid or the uterus so that it can be extracted. The smaller incision made recovery time shorter. However, studies showed that undetected cancerous cells in the uterine area could be spread throughout the body as a result of the process. One of the lawsuits against Johnson & Johnson is currently involved in settlement talks.
FDA Issues Warning to Doctors Regarding Morcellation
In November of 2014, the FDA issued a safety communication related to the use of morcellators. They also issued a box label warning about the significant risks. The devices were not removed from the market. According to the data that was received and analyzed by the FDA related to the risk of spreading previously undetected cancerous cells throughout the body, around 1 in 350 women who are undergoing treatment for fibroids have undetected cancer, including leiomysosarcoma, a type of uterine cancer. The FDA stated that the use of a morcellator could “decrease the long-term survival of patients.”
Doctors Continue to Use Morcellators
Directly after the release of the safety communication from the FDA, doctors reduced their use of the morcellator. However, it doesn’t appear to be out of a concern for the health and safety of their patients. According to the Journal of Minimally Invasive Surgery in 2016, the use of morcellators went down “only to prevent legal litigation.” Even then, only around half of gynecologists reduced their use of the device.
Yet, many doctors believe that a morcellator is worth the risk of a morcellation lawsuit because of the lowered risk for cancerous fibroids and uterine concerns in younger women. Recently, morcellator bags were created that are meant to contain the material so that if there are cancerous cells, they are not released into the body. The PneumoLiner contains the morcellator and the tissue, but there’s a problem with the bags. In April of 2016, the FDA reported that this should still only be considered if patients are well-informed of the risks. PneumoLiners were reviewed in November 2016 by the Journal of Minimally Invasive Surgery. Four out of twelve uses of the bag resulted in the bags ripping or tearing during the procedure. That means one-third of the patients ran the risk of being exposed to undetected cancerous cells.
Did You Develop Cancer After Morcellation?
If you developed cancer after undergoing a morcellation of fibroids or uterine tissue, you may benefit from a morcellation lawsuit. Goldwater Law Firm represents patients and their families who were hurt or who died as a result of defective medical procedures, devices, or medications. To learn how Goldwater Law Firm may be able to help you, schedule your free case review now.