The FDA has approved a third “gummy bear” breast implant. MENTOR’s MemoryShapeTM Breast Implants, formerly known as the CPG implant, now joins Sientra’s shaped implants and Allergan’s Natrelle 410.
|
|
(HealthNewsDigest.com) – All three of these brands fall under the umbrella of “gummy-bear” breast implants. While many companies and doctors are trying to distance themselves from this marketing term, it seems to resonate most with American women who are considering breast augmentation or reconstruction.
This new generation of breast implants are filled with a form-stable, highly-cohesive silicone gel. Much like a gummy bear candy, in the unlikely event that it ruptures, the gel would not migrate, which is considered a benefit in terms of safety. They are also “shaped” to resemble a natural woman’s breast, rather than round like conventional breast implants.
MemoryShape breast implants from Mentor (http://www.mentorwwllc.com) are approved for cosmetic breast enlargement in women at least 22 years old, and for breast reconstruction following breast-removal surgery in women of any age.
Now women have three “shaped,” “form-stable” choices, which offer new options previously unavailable in the U.S. The overwhelming response from board certified plastic surgeons has been positive.
Given the popularity of breast augmentation, this represents a major advance. What’s more, recent attention to the merits of gene testing followed by prophylactic mastectomy and reconstruction for women, like Angelina Jolie, who are considered high risk for breast cancer may encourage more women to get tested.
The approval is based on a six-year study of more than 950 women that showed the implants were safe and effective. The FDA is asking Mentor to conduct several post-approval studies to make sure that there are no long-term complications or red flags with the new MemoryShape implants. This is not unusual; the FDA required the same of Sientra and Allergan when their breast implants were approved.
Grand Rapids, MI-based plastic surgeon Dennis Hammond was one of the investigators in the trial that led to the new implant’s approval. He says that they offer some cosmetic and safety pluses when compared to other implants out there. “These implants provide very good augmentation because of upper-pole fullness that a lot of women are looking for,” he says.
In general, “the shaped implants offer significant advantages over the round implants and they really perform well safety wise.”
David L Cangello, MD, an attending plastic surgeon at Lenox Hill Hospital and Manhattan Eye Ear and Throat Hospital in New York City, is also enthused about the new option. “The approval of the Mentor Memory Shape implants by the FDA is exciting as it provides women who are seeking breast augmentation, one of the most common cosmetic surgical procedures performed another option for breast enhancement,” he says.
Still, he says, “These implants are not for everyone. They are best suited for women who want a more natural appearing (tear-drop shape) breast and who do not need or want to add volume to the upper pole of the breast. These implants are also a bit firmer than the round gel implants due to the fact that a more cohesive gel is used to fill the implants so that they maintain their tear drop shape.”
Additional reporting by Denise Mann
Wendy Lewis is President of Wendy Lewis & Co Ltd Global Aesthetics Consultancy, author of 11 books and Founder/Editor in Chief of http://www.beautyinthebag.com.
###
For advertising and promotion on HealthNewsDigest.com call Mike McCurdy at 877-634-9180 or [email protected] We have over 7,000 journalists as subscribers who have access to our content for their own media.