Hysterectomy Device Recalled Amid Cancer Fears
Audet & Partners, LLP reports that Ethicon Endo-Surgery Inc., a unit of Johnson & Johnson, is voluntarily asking doctors to return a device used in performing hysterectomies in thousands of women. Ethicon’s Morcelex device, used in certain laparoscopic surgeries, has come under FDA scrutiny because of the potential of such devices to spread cancerous fibroids.
The class of devices known as morcellation devices, which includes Ethicon’s Morcelex device, is used in many hysterectomy procedures to break non-cancerous fibroids into smaller fragments which are then removed through an insertion in the stomach. The FDA has recently subjected this class of devices to heightened scrutiny because of the potential role of morcellation devices with symptomatic fibroid disease.
In addition, a lawsuit was brought earlier this year in New York by a woman claiming to have been diagnosed with cancer after undergoing a robotic hysterectomy. In the New York lawsuit, the plaintiff alleged that Ethicon failed to adequately test its Morcelex product for potentially dangerous side effects.
If you or a loved one has suffered serious side effects arising after a procedure using a medical device such as Morcelex, you are urged to contact a medical device attorney at Audet & Partners, LLP by calling (800) 965-1461, or by completing and submitting our confidential online inquiry form on the right side of this page.