Product News and Recalls

FDA Addresses Cancer Risk of Morcellation Devices

A panel of Food and Drug Administration experts says that it is unlikely that power morcellation can be used to remove fibroids from women without the risk of spreading undetected cancers to other parts of the body. The FDA takes into consideration the opinions of its health advisors on these panels when making regulatory decisions about medical devices.

Power morcellators are used in the removal of fibroids and in some hysterectomies. Fibroids can cause severe pain, heavy bleeding, and bladder and bowel dysfunctions. Laparoscopic power morcellators are used in hysterectomies to grind tissue or to remove fibroids through an incision in the abdomen. The technique requires a small incision and was developed as an alternative to traditional surgery with larger incisions that result in more bleeding and longer hospital admissions.

In April, the FDA issued a safety communication urged doctors and surgeons to halt the use of morcellators after scientists found that laparoscopic power morcellation increases the risk of spreading undetected cancerous tissue to other parts of the body. The FDA’s research indicates 1 in every 350 women who have surgery for the removal of uterine fibroids have undiagnosed uterine cancer known as leiomyosarcoma.

The FDA’s panel of obstetrics and gynecology experts said there is no evidence showing that plastic specimen bags, used to catch bits of shredded tissue, or any other containment devices can prevent the spreading of the cancerous tissue. The panel also discussed that screening for uterine sarcoma is unlikely to be effective because it is difficult to distinguish between cancerous and normal fibroids through modern imaging techniques.

Power morcellators have been approved by the FDA since 1995 and about two dozen have been approved. They were not scrutinized carefully during the review proves because they were seen as similar to manual surgical devices that had previously been approved. Johnson & Johnson, the primary manufacturer of power morcellators, has suspended the sale of these devices since the FDA announced its safety concerns in April.

People who are injured by medical devices or medical malpractice may be able to recover significant compensation for their injuries and losses. Because these cases often involve complicated and technical issues related to medical conditions and FDA rules and regulations, it is important for victims to discuss their case with an attorney with experience in these types of cases. The attorneys of Lopez McHugh, LLP are ready to assist with a free, no-obligation consultation.