Johnson & Johnson unit Ethicon Endo-Surgery Inc. has asked doctors to return a surgical device used in a now controversial hysterectomy procedure that the U.S. Food and Drug Administration has warned could spread cancerous tissue into a patient’s abdomen. Johnson & Johnson executed a worldwide withdrawal of its Morcelex device following a recent meeting with the FDA. The agency is weighing regulatory actions to reduce the risk of cancer spread during uterine fibroid removal procedures.
In April, Ethicon said it had suspended the sale, distribution and promotion of the morcellation devices “while the role of morcellation with symptomatic fibroid disease is redefined by the FDA and the medical community,” according to a company statement issued that month. Laparoscopic power morcellation, one technique used to treat mostly non-cancerous fibroids, uses a device to break uterine tissue into fragments that can be removed through an incision in the stomach, according to the FDA. Although uterine fibroids are common and usually benign, they may occasionally be cancerous, the agency said.
Typically, power morcellators are used to cut the fibroid or uterine tissue into pieces that can be pulled out through abdominal incisions. But according to FDA data, approximately one in every 350 women with fibroids could have a uterine sarcoma and slicing up the cancerous tissue could allow it to spread and reduce a patient’s long-term survival rate. Of the 500,000 hysterectomies performed every year, approximately 11 percent are done using power morcellators via laparoscopic surgery, according to the FDA. However, the regulator did note that these laparoscopic surgeries may still be the best available for some patients, and it’s leaving those decisions up to the individuals and their health care providers.
If women with such unsuspected cancerous fibroids undergo morcellation, there is a risk of spreading those cancerous fragments beyond the uterus, making such cancers harder to treat, the agency warned in April. Although the regulator didn’t remove the nearly two dozen approved power morcellators from the market, it warned doctors to consider other treatment methods for symptomatic fibroids rather than using the tool to remove fibroids or a woman’s uterus laparoscopically.
The first suit over the product was filed in May against Ethicon in New York federal court. Plaintiffs Brenda Leuzzi and George Leuzzi, who filed the suit, claim that Brenda was diagnosed with cancer after undergoing a robot-assisted hysterectomy with morcellation in 2012 and that the company did not adequately test its Morcelex product for potentially dangerous side effects.
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