FDA Approves MENTOR® MemoryShape™ Breast Implants
According to The Business Journal, U.S. market leader in breast aesthetics announced the U.S. Food and Drug Administration (FDA) has approved MENTOR® MemoryShape™ Breast Implants, providing new options for women looking for a more natural shape and youthful feel from breast enhancement or reconstruction surgery.
Unlike round implants, MENTOR® MemoryShape™ Breast Implants have a teardrop shape, much like the shape of a natural breast. They have been approved for more than a decade outside of the U.S. and are filled with a uniquely formulated cohesive gel that enables shape retention, while providing a natural silhouette and youthful firmness. The combination of teardrop shape and distinct gel formulation creates the optimal balance of shape and feel. MENTOR® MemoryShape™ Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction.
“Over the past 25 years, we have been exploring opportunities to improve breast implants. MENTOR® MemoryShape™ Breast Implants incorporate several new design features, such as the cohesive gel that allows the implant to be formed into a teardrop shape to fit each individual patient,” said Dennis Hammond, M.D. of Partners in Plastic Surgery of West Michigan, and lead investigator of the MENTOR® MemoryShape™ Breast Implants clinical trial. “I am pleased women in the U.S. now have an implant that offers an enhanced yet subtle breast appearance with a proven safety profile.”
To help surgeons find the ideal size and fit for their patients, MemoryShape™ Breast Implants are available in a range of sizes. Dr. Mark Mandell-Brown was voted “TOP DOCTOR” in Breast Augmentation by his Physician Peers in the Dayton, Cincinnati, Ohio area in January 2013. He utilizes MENTOR® implants which are made in the USA.
Breast implants may not be suitable for everyone. Women should speak with a plastic surgeon to learn if implants are right for them.
*MENTOR® MemoryShape™ Breast Implants Important Safety Information Disclaimer
MENTOR® MemoryShape™ Breast Implants are indicated for breast augmentation in women at least 22 years old, or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body, with existing cancer or pre-cancer of their breast, who have not received adequate treatment for those conditions, or who are pregnant or nursing.
There are risks associated with breast implant surgery. Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. You may need additional unplanned surgeries on your breasts because of complications or unacceptable cosmetic outcomes. Many of the changes to your breast following implantation are irreversible (cannot be undone) and breast implants may affect your ability to breastfeed, either by reducing or eliminating milk production. The most common complications with MENTOR® MemoryShape™ Breast Implants include reoperation for any reason, implant removal with or without replacement, and ptosis. A lower risk of complication is rupture, which is most often silent (meaning neither you nor your doctor will know you have a rupture) and can only be detected by appropriate imaging techniques such as MRI. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture.