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FDA Approves Natural-Looking Gel Option in Breast Implants

Newly available teardrop-shaped breast implants provide natural silhouette and youthful feel

Used for over a decade in 70-plus countries, MENTOR MemoryShape teardrop breast implants have been finally approved by the FDA. Filled with a highly cohesive gel that mimics and retains the shape of the breast, the implants provide a natural look and youthful firmness.

They differ from round implants in that they are thinner at the top and gently slope towards the bottom. Additionally, they are designed to stay in place using a texturized shell that minimizes shifting.

 

Approval was based on six years of data from 955 women participating in an ongoing 10-year study. The implants showed a reasonable assurance of safety and effectiveness, with similar rates of complications and outcomes as previously approved breast implants. These complications included tightening of the area around the implant; re-operation; implant removal; an uneven appearance (asymmetry); wrinkling; and occasional gel fractures, fissures or cracks in the gel.

Overall, study participants also expressed high satisfaction rates with their breast appearance, with 97 percent reporting they would repeat the procedure. “Over the past 25 years, we have been exploring opportunities to improve breast implants,” remarked Dennis Hammond, M.D. of Partners in Plastic Surgery of West Michigan, and lead investigator of the clinical trial. The implants “incorporate several new design features to fit each individual patient. Women in the US now have an implant that offers an enhanced yet subtle breast appearance with a proven safety profile.”

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