Philadelphia Defective Device Lawyers Warn of Power Morcellator Risks
Uterine fibroids are non-cancerous growths that 70 to 80% of women will experience before the age of 50. Although they are not life-threatening, fibroids cause debilitating pain, heavy bleeding and other complications. When a hysterectomy is advised by a physician, laparoscopy is frequently discussed as a viable surgical option. Unfortunately for some women, what started out as a straightforward solution to a common problem – laparoscopic removal of fibroids – can prove deadly, depending upon how their surgery was performed.
A power morcellator uses rotating blades to divide large tissues masses into smaller fragments which are then suctioned from the body. Because they allow for a point of entry as little as two centimeters wide, patients enjoy faster, less painful post-operative recoveries. For that reason, power morcellators for many years were used not only during hysterectomies, but also during the removal of individual fibroids (known as myomectomy) and even during the removal of other organs like a kidney or spleen. In April of 2014; however, the U.S. Food and Drug Administration (FDA) formally discouraged healthcare providers from using power morcellators in the treatment of uterine fibroids.
FDA: Device Usage Contraindicated For Most
According to the FDA’s official “Safety Communication,” power morcellators unintentionally spread undetected uterine sarcomas – including leiomyosarcoma, a highly malignant form of uterine cancer – throughout the abdomen and pelvis. When a surgeon uses a power morcellator to slice and remove suspected fibroid tissue, but the fibroid tissue is in actuality a uterine sarcoma, the once-localized cancer cells are rapidly and uncontrollably dispersed to new areas. Not only will these cancer cells begin to grow again, the FDA says they will often grow more aggressively than they did before, thereby “significantly worsening the patient’s likelihood of long-term survival.”
In November of 2014 the agency went one step further with the issuance of an “Immediately in Effect” (IIE) guidance. In the document, the FDA deems gynecologic power morcellator usage a “significant public health issue” and recommends that device manufacturers include warnings on all morcellator packaging. Specifically, the FDA said that morcellator manufacturers must make it clear that uterine tissue may contain unsuspected cancer which can be worsened by morcellation. The package warnings should also note that power morcellators are not to be used to remove uterine tissue in patients who are peri- or post-menopausal, or who are candidates for an alternative method of hysterectomy or myomectomy. Lastly, the FDA recommends that packaging should state that power morcellators are contraindicated in tissues that are “known or suspected to be cancerous.”
There are numerous safer ways to treat women suffering from fibroids including traditional hysterectomy and myomectomy; laparoscopic hysterectomy and myomectomy without morcellation; vaginal hysterectomy; drug therapy and high-intensity focused ultrasound according to the FDA. But because an estimated one in 350 women undergoing hysterectomy or myomectomy are believed to have undiagnosed uterine sarcoma – for which there is currently no reliable method of detection – the agency urges surgeons to refrain from power morcellator use during treatment for fibroids.
Philadelphia Medical Device Lawyers at the Shein Law Represent Uterine Cancer Victims
In light of the FDA’s action, serious questions are now being raised about what – and when – medical device makers knew about the dangers posed by power morcellators. If you or a loved one was diagnosed with cancer after undergoing a hysterectomy or myomectomy via power morcellation and you were never warned of the risks, you may be entitled to compensation. Contact Philadelphia defective device lawyers at Shein Law at 1-877-SHEINLAW (1-877-743-4652) or complete an online contact form today to schedule a free consultation. With offices in Philadelphia, PA and Pennsauken, NJ, we serve clients throughout the Philadelphia and New Jersey region.