The Food and Drug Administration (FDA) has announced a warning with regards to medical devices used during laparoscopic surgeries in procedures such as a hysterectomy or myomectomy whereby the uterus or uterine fibroids are removed in pieces through small incisions. The problem lies in the fact that power morcellators pose the risk of spreading cancerous tissue, specifically uterine sarcomas, beyond the uterus where the cancer can attack normally healthy tissue.
Uterine fibroids are growths that form on the muscular tissue of the uterus, and they are non cancerous by nature. The FDA states that most women will develop uterine fibroids at sometime in their life, which will cause no symptoms. However, there have been some reports of prolonged or heavy menstrual bleeding, pain or frequent urination.
Women today choose laparoscopic procedures for hysterectomy or myomectomy because the procedure is much less invasive, utilizing medical devices and tools inserted through small incisions in the patient. The benefits include increased recovery time, and reduced risk of infection compared to a traditional hysterectomy or myomectomy. The medical device used in many hysterectomies and myomectomies is a power morcellator.
Current estimates from the FDA indicate that 1 in 350 women will have an unsuspected uterine cancer resulting from a laparoscopic hysterectomy or myomectomy. There is no reliable way to determine if a patient with fibroids will develop a uterine sarcoma (cancer). While they do not have actual estimates, the FDA believes the risk to be greater than previously expected.
The FDA States that “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.” Because of this risk, the FDA warns against using Power Morcellators during fibroid treatments such as hysterectomies and myomectomies.
If you have had a hysterectomy, myomectomy, or any fibroid removal procedure, ask your physician if a power morcellator was used. If so, ask if they checked the tissue removed for the presence of cancer. If you are about to have a procedure done, ask you care provider if they anticipate using a power morcellator to perform the operation and why they believe that is the best choice for you. Inquire about other options that may be available for your particular condition.
If you have developed any form of uterine cancer that may have been a result of hysterectomy, myomectomy, or fibroid removal treatments involving a power morcellator, you may have rights to compensation for your injuries, your medical bills, and your pain & suffering. Speak to a product liability attorney at our law firm today to discuss your legal rights to compensation, we offer a FREE Consultation to get started right away.