Washington ? In a surprising turnaround, federal health advisers Wednesday recommended allowing silicone-gel breast implants to return to the U.S. market after a 13-year ban on most uses of the devices — but only under strict conditions that will limit how easily women can get them.

Mentor Corp. persuaded advisers to the Food and Drug Administration that its newer silicone implants are reasonably safe and more durable than older versions. The 7-2 vote came just one day after a rival manufacturer, Inamed Corp., failed to satisfy lingering concerns about how often the implants break apart and leak inside women’s bodies.

FDA’s advisers said Wednesday that Mentor had performed more convincing research that the implants only rarely break shortly after they’re inserted — about 1.4 percent over three years — and showed some evidence that they may last as long as 10 years.

They stressed that sales should resume only if Mentor meets some strict conditions:

• Prospective patients must sign consent forms acknowledging implant risks, including that they ultimately may break and require removal or replacement.
• Mentor may sell silicone implants only to board-certified plastic surgeons who complete special hands-on training to insert implants in a way that minimizes odds of breakage.
• Mentor must open a registry to track how patients fare long-term, and it must continue more formal studies to nail down how often implants rupture within 10 years, something no one yet knows.
• Mentor must warn that because implant breaks don’t cause immediate symptoms, patients should get an MRI scan five years after implant insertion and every two years after that. They should consider having broken implants removed to minimize risk of silicone oozing into the breast, or beyond.

“We are holding it to higher standards than other implants,” said FDA adviser Stephen Li.