A hysterectomy ranks second behind a cesarean section (“C-section”) as the most frequently performed medical procedure women undergo. In fact, the National Women’s Health Network lists statistics reporting an estimated 600,000 hysterectomies performed every year. It is common for laparoscopic power morcellators to be used during this type of surgery as well as for myomectomies (removal of uterine fibroids). Unfortunately, nearly 1 in 350 women who undergo one of these two surgeries has unsuspected uterine cancerous tissue.
The use of laparoscopic power morcellators during either of these procedures puts women at risk of having previously undetected cancerous cells spread throughout the abdomen and pelvis. The FDA recently updated its safety alert regarding these medical devices and warns against their use during a hysterectomy or myomectomy in the majority of women. The administration emphasizes that laparoscopic power morcellators should not be used in women with suspected or known uterine cancer.
The FDA has also issued a guidance document with a manufacturer recommendation to update product labeling to include specific safety information through a boxed warning. The boxed warning advises that laparoscopic power morcellators should not be used:
- In perimenopausal or postmenopausal women for removing uterine tissues containing suspected fibroids; and
- In gynecologic surgery where tissue is known or suspected to be cancerous.
Quality of life and long-term survival rates can be compromised if laparoscopic power morcellators are used and result in the spreading of cancer cells. Alerts and labeling recommendations are crucial for health care providers and their patients so that alternative treatment options can be considered.
Manufacturers should take these suggestions seriously and update labeling accordingly when their products have been deemed unsafe. When there is a failure to properly inform of potential risks a product carries and patients are injured as a result, manufacturers maintain liability for damages.
Our law firm has fought for and won million dollar settlements for our clients when defective products have caused harm. We will fight for you. If you or a loved one has been injured as a result of a defective medical device, contact an experienced Chicago product liability attorney today.
