Power Morcellation FAQs
Q: What is power morcellation?
Power morcellation is a surgical technique used during operations such as hysterectomies (removal of the uterus) and uterine fibroid procedures (removal of non-cancerous growths along the wall of the uterus). The technique is named "power morcellation" because it involves a tool known as a power morcellator. This tool has a long, shaped tube with blades that can break up tissue, allowing the resulting tissue fragments to be removed through small incisions. The primary benefit of power morcellation is that it's a minimally invasive procedure, allowing for quicker recovery times than traditional surgery.
Q: Are there different types of power morcellation?
The type of power morcellation procedure described above is known as open power morcellation. There's also a second style called "in bag" power morcellation because the tissue is covered in a bag before being broken up. While some medical authorities believe the "in bag" method to be safer than open power morcellation, it's used less frequently because few surgeons are experienced in the technique.
Q: Are there risks associated with power morcellation?
Power morcellation has recently come under scrutiny due to serious complications linked to the procedure. In April 2014, the U.S. Food and Drug Administration (FDA) announced that power morcellation could inadvertently spread cancerous tissue into other parts of the body. The FDA estimates that 1 in 350 women undergoing a hysterectomy or uterine fibroid removal have an undetected type of cancer known as uterine sarcoma. If power morcellation is performed on a woman with uterine sarcoma, cancerous tissue may be broken up and spread within the pelvic region and outward to the abdominal region. This spread of cancerous material can have serious health consequences for patients.
Q: What has been the FDA's response to the suspected connection to cancer?
Since there is no reliable method of determining whether a woman with fibroids has uterine sarcoma, the FDA has strongly advised healthcare professionals to cease the use of power morcellation during hysterectomies or uterine fibroid removals. In addition, the agency instructed power morcellator manufacturers to reevaluate the accuracy of their risk information. The FDA also plans to hold a public meeting with the nation's top obstetricians and gynecologists to further discuss the risks involved with power morcellation.
Q: How have the manufacturers of power morcellators responded to the FDA alert?
Shortly after the FDA's statement discouraging the use of power morcellation, Johnson & Johnson (J&J) announced it would suspend sales, promotion, and distribution of all power morcellators. The world's largest maker of power morcellators, J&J said it would need to perform additional research and consult with the medical community before determining the product's future.
After three months and growing criticism of their response to this matter, J&J did withdraw the tissue morcellators from the market. In July 2014, J&J sent letters to doctors and hospitals that already had these devices to request they return them to J&J and not use them anymore. The three tissue morcellator models are:
- Gynecare Morcellex tissue morcellator
- Gynecare X-Tract tissue morcellator
- Morcellex Sigma tissue morcellator system
Q: Can manufacturers be held liable for injuries caused by power morcellators?
Under product liability law, manufacturers and sellers have a duty to ensure that their products are free from any unreasonable dangers or defects. That goes for medical device manufacturers as well. When a patient is injured by a defective medical device, he or she can file a product liability suit against the manufacturer in order to receive compensation. For a product liability claim to be successful, the plaintiff must prove two elements: first, that the product is defective, and second, that the defect caused the plaintiff’s injuries.
For example, a patient who is injured by a power morcellator may file a defective warning claim against the manufacturer of the device. Manufacturers have a duty to warn consumers of any reasonable dangers associated with their products. In such a case, the plaintiff may allege that the manufacturer was aware of the danger of spreading cancer cells -- especially after the FDA warnings were issued -- but continued to sell the device without informing patients of the risk.
A successful product liability suit can provide patients with compensation for their medical expenses, lost wages, and pain and suffering. If you've been injured as the result of a power morcellation procedure, it's in your best interests to discuss your legal options with a product liability attorney.