Citizen Petition Raises Concerns About Robotic Mastectomy Trial
One doctor is using his expertise to advocate for better premarket surveillance of cancer-treatment devices.
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In a report on Bayer’s postmarket study of Essure, the FDA says Bayer’s study is back on track with its five-year plan.
Though the FDA has approved robotic assisted surgery for many procedures, the US agency cautions that safety and efficacy of the technology has not been well-established for cancer-related surgeries, particularly mastectomies.
The new guidance from the US FDA urges physicians to discuss with patients the benefits and risks of using a laparoscopic power morcellator to remove uterine fibroids, and adds some language around LPM containment systems that wasn’t included in the draft of the document.