BOSTON — In light of recent deaths, lawsuits, and FDA warnings regarding the risks of using power morcellators, a new surgical tool may be released soon as a safer alternative.
Major medical manufacturer Boston Scientific announced it will soon release a supposedly safer alternative to power morcellators, the Symphion System. Like the power morcellator, the Symphion system is supposed to remove intrauterine fibroids through a minimally invasive procedure in the uterus. The Symphion System is a self-contained device that removes uterine tissue without a blade and is designed to limit the amount of fluid that can be re-absorbed by the patient’s body – i.e. limit the spread of cancer.
It, of course, remains to be seen if the Symphion is able to serve as a safer alternative to the power morcellator. The dangers, increasing lawsuits, and FDA warning demand for a safe, non-cancer spreading alternative to be developed quickly. In the meantime, women undergoing the removal of polyps or intrauterine fibroids need to be aware of the dangers involved in such a procedure.
The power morcellator is a popular surgical device that is designed to be used during myomectomy or hysterectomy procedures. It is a small device with rotating blades that is used to eviscerate tissue into smaller fragments through a very small cut. These fragments are then vacuumed out of the body. The goal is to remove uterine fibroids. The removal of such fibroids is supposed to reduce the risk of intraoperative and postoperative problems such as infection, bleeding, deep vein thrombosis, enlarged uterus, and other injuries.
Uterine fibroids occur in almost 80 percent of women over the age of 50. They are non-cancerous tumors. However, they are hard to distinguish from cancerous tissue. Often, doctors do not realize the tissue was cancerous until well after the surgery. Metastatic leiomyosarcoma is the most common and dangerous form of soft tissue sarcoma that hides within/under/near this fibroids or is mistaken for a uterine fibroid. It is a very rare and unpredictable type of cancer that often remains dormant for years. The FDA estimates that “1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.”
The use of power morcellators has been found to exacerbate the risk of cancer or spread cancer unknowingly through the body because the cancerous cells are hidden or mistake for uterine fibroids. During the morcellation process, the fibroids are ripped to shreds in order to make for an easier removal. Unfortunately, this means the hidden cancerous cells are also cut into smaller pieces and dispersed throughout the body. As a result a seemingly dormant cancer now has access to other organs and tissue and is able to spread very quickly. In many cases this has resulted in the spread of very aggressive and resistant cancer in women who have undergone the procedure, and in a growing number of cases, leading to their death.
If you or a loved one has undergone any procedure involving power morcellators and is now suffering from harm, please consult your physician and contact an experienced attorney.
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