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“We know minimally invasive surgery offers a lot of benefits and we want to be able to offer it to as many women as possible. These types of devices and innovation need to be tested. Theoretically, this should be a safe procedure, morcellating in a bag and trying to limit interabdominal dissemination. But, until this is thoroughly investigated, we won’t know the safety of this.” It is possible that occult microscopic tumor cells can still escape the bag, Wright added. “We don’t กระเป๋าเป้ nike really know the true incidence of rupture of the bag and spillage of the contents,” he said. “One of the problems with morcellators is that they’ve been diffused in practice without solid scientific evidence, and this is the exact type of study we need to be doing to get this evidence before these devises are used widely in practice.” Because the incidence of occult cancer is higher in postmenopausal women undergoing hysterectomies, if the PK morcellator and PneuemoLiner bag are found effective, more oncologists may recommend the procedure for premenopausal women requiring laparoscopic hysterectomies, Wright said. “In postmenopausal women, in particular, the risks of the procedure may outweigh the benefits,” he said. “In younger women, the risk for cancer is still quite low and in these women, the benefits of being able to have a minimally invasive surgical procedure may outweigh the small risks associated with morcellation. If the bag is found to be a safe technology and there is published data on this, I would think it would start to diffuse into practice again.” – by Chuck Gormley FDA. Immediately in effect guidance document: Product labeling for laparoscopic power morcellators. 2014.
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