A report published in the Pittsburgh Business Times indicates that the Johnson & Johnson subsidiary responsible for manufacturing power morcellators was warned eight years ago that their device could increase the risk of spreading cancer. The news is based on a series of communications between the company and a Pennsylvania pathologist, Dr. Robert Lamparter, who requested that Johnson & Johnson reconsider the risk posed by power morcellators when performing hysterectomies or removing uterine fibroids.
The devices at issue allow surgeons to perform minimally invasive procedures through small incisions by breaking tissues up into smaller pieces. Currently available data indicates that power morcellation also increases the risk of spreading cancerous tissue to other parts of the body. The Federal Food and Drug Administration (FDA) issued a Safety Communication in April of 2014 indicating that the agency discourages the use of power morcellation in performing hysterectomies or myomectomies of uterine fibroids. According the FDA, approximately 1 in every 350 women who undergo these procedures also has an undiagnosed form of cancer known as uterine sarcoma. When power morcellation is utilized in the treatment of patients with uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue to other parts of the pelvis and abdomen, potentially reducing the patient’s chances of long-term survival.
As a result of these risks, the FDA is recommending that health care providers refrain from using power morcellators when removing the uterus or treating uterine fibroids. In addition, the agency is recommending the following for women:
- Discuss all possible treatment options as well as their respective risks and benefits with their healthcare providers.
- If your healthcare provider recommends a laparoscopic hysterectomy or myomectomy, ask why they recommend the procedure and whether power morcellation will be used.
- If you have already undergone a laparoscopic hysterectomy or myomectomy and the removed tissue tested as normal, follow-up with your healthcare provider on a routine basis.
The FDA is convening a public meeting of the Obstetrics and Gynecological Medical Devices Panel to further discuss the role of power morcellation in laparoscopic surgery.
Contact a Medical Device Injury Lawyer Today for a Free Consultation
Individuals and family members of those who have been injured by power morcellation or other medical devices may be entitled to receive significant financial compensation for their losses. Contact the attorneys at Lopez McHugh, LLP today to schedule a free consultation either by calling (877) 737-8525 or using our website.