Dr. Gryskiewicz said that he nevertheless advises his patients that they will need the tests. But he is also developing an alternative diagnostic tool, called Novalert, a dime-size radio-frequency identification tag that fits on the back of an implant and emits a signal if it senses leaking silicone. “The M.R.I. is the best test we have at the moment, but we need a better system,” he said. Other doctors said M.R.I.’s occasionally give false-positive results that could cause women with intact implants to have unnecessary surgery to take them out. Still others questioned the advisory to automatically remove a ruptured implant, contending that silicone is benign. Dr. Richard Ellenbogen, a plastic surgeon in West Hollywood, said he has put in thousands of implants and has never seen major problems. “In my opinion, a rupture is not going to hurt anyone,” he said, adding that “radiologists are going to make a lot of money paying off their $800,000 machines.” Declining to follow labeling instructions for a medical device is not a legal issue. The F.D.A. regulates drugs and devices, leaving doctors free to practice medicine using approved products in unapproved ways if they deem it medically appropriate.
