The FDA is reviewing comments on whether it should take regulatory action in response to the risks posed by the devices, which cut fibroid or uterine tissue into small pieces to make it easier to remove during minimally invasive surgery. The comment period closed on Aug. 19.
Johnson & Johnson, estimated to have about two-thirds of the U.S. market for the devices, suspended sales of its morcellators in the U.S. in April after the FDA discouraged doctors from using the tool given the risk that it could spread undetected uterine sarcomas. Last month, Johnson & Johnson said it would go a step further and ask surgeons to return the devices. The other companies that sell laparoscopic morcellators in the U.S. are Karl Storz, Richard Wolf, Lina Medical, Trokamed and Gyrus.
Smith & Nephew, which manufactures the Truclear hysteroscopic morcellator system, told the agency in a comment letter (PDF)that the company is “deeply concerned about the confusion and unintended consequences” of the agency's warnings about the technology.
The Cordova, Tenn.-based devicemaker said the FDA warning and media reports have made it hard for women to get unrelated and safe procedures.
Organizations representing gynecologists, meanwhile, have argued against restrictions because the tool has enabled women to receive minimally invasive procedures rather than open procedures, which can be more dangerous for many women.
The Society for Gynecologic Oncology, for example, said in a comment letter to the FDA (PDF) that the conclusions of the studies driving the controversy are “questionable” and that “banning morcellation may cause more harm to more women.”
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