The MemoryShape Breast Implants Get FDA Approval

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When it comes to breast augmentation and reconstruction, there are a variety of implants that patients can choose from. After a recent Food and Drug Administration (FDA) approval, there are now five FDA-approved silicone gel-filled breast implants available in the U.S. Silicone implants are available in different shapes and sizes and have either a smooth or textured silicone outer shell that is filled with silicone gel.

The MemoryShape Breast Implants, manufactured by Mentor Worldwide, are teardrop-shaped to mimic the appearance of natural breasts and are created with a textured effect to better help keep the implants in place. Compared to other Mentor implants, the MemoryShape implants are made with a firmer-feeling silicone gel.

The FDA’s approval is based on data from 955 women over the course of six years. The MemoryShape implant showed similar complications and outcomes to previously approved silicone gel-filled implants from Mentor, Allergan and Sientra. The FDA did observe gel fracture—fissures or cracks in the gel—in some MemoryShape Breast Implants.

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” says Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The data we reviewed showed a reasonable assurance of safety and effectiveness.” However, the FDA requires that Mentor conduct a series of post-approval studies to assess the safety, effectiveness and health risks associated with the implants. “We will be looking at the results from post-approval studies that will focus on the implants’ long-term safety and effectiveness," Dr. Shuren says.

What type of breast implants do you have or want to get?

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