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FDA Clears Allergan, Mentor Implants

Silicone breast implants will return to the market.


(AGN) - Get Allergan plc Report

rose 3% in late trading Friday after the U.S. approved a silicone-gel implant made by its Inamed unit.

The decision ended a 14-year virtual ban on the implants despite lingering safety concerns, the Associated Press reported.

"Allergan is pleased that the FDA has further recognized the vast body of scientific evidence supporting the performance of these devices and has approved Inamed Silicone-Filled Breast Implants for re-entry to the U.S. market," said CEO David E.I. Pyott. "Our ability to offer surgeons in the United States a comprehensive portfolio of saline-filled and silicone gel-filled breast implants results in greater options for women considering breast augmentation, reconstruction or revision surgery."

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also received approval for its implant product.

"At this historic moment for Mentor, we would like to recognize with gratitude the dedication of the patients, nurses, and surgeons who have participated in the studies that provided the clinical and scientific support for this approval," said CEO Joshua H. Levine. "Over the past 14 years we have remained devoted to returning MemoryGel(TM) implants to the U.S. market, and we are pleased to be able to provide women seeking breast augmentation and reconstruction with important new options."

Allergan rose $3.60 to $116.10. Shares in Mentor were halted.