Breast Implant Registry Applauds Mentor's FDA Approval Letter

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Breast Implant, the only internet-based registry of breast implants, cheered news that the FDA had given an approval letter to Mentor Corporation for silicone gel implants.

Breast Implant, the only internet-based registry of breast implants, applauded news that the FDA had sent an approval letter with conditions to Mentor Corporation for their silicone gel implants. While the exact terms of the approval letter have not been released, the FDA scientific advisory panel recommended in April that a breast implant registry be established to track the new implants.

“We are excited about the reintroduction of silicone gel implants into the market and the prospect of helping women, their doctors and the implant manufacturers track these products as they return to widespread use,” said Dr. Robert Frank, a board certified plastic surgeon and President of “We feel the registry is critical to proving the safety of these implants.”

Frank started in 2004 in response to the growing number of women needing revisional breast implant surgery who did not have important data from their initial surgery. Often the lack of this critical information complicated their secondary procedure leading to increased surgical time, recovery time and cost.

The registry,, allows women to access all breast implant related data from anywhere with internet access. Data regarding surgeon, surgery center and implants is kept on a secure, encrypted server. The cost of enrollment in the registry $25 for 10 years. Patients with implants placed for cosmetic or reconstructive purposes are candidates for enrollment.


Robert Frank, MD

Breast Implant,



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