Mentor CPG MemoryShape Breast Implants are now FDA Approved

Posted June 15, 2013 in Breast Augmentation, Breast Reconstruction, Home

Mentor Memory Gel

Mentor Corporation of Santa Barbara, California, announced FDA approval of their shaped, highly cohesive, MemoryShape Breast Implants. This marks the third teardrop shaped silicone breast implants approved for use in the US, and the culmination of 25 years of Mentor breast implant research.

Who benefits from shaped breast implants?

Mentor now joins Sientra and Allergan in offering a soft, “solid,” teardrop shaped breast implant, for women who need additional fullness in the lower half of their breasts. Better known as gummy-bear breast implants, these types of implants offer some advantages for women desiring breast reconstruction after a mastectomy for breast cancer, and for women with little lower pole breast tissue desiring breast augmentation with breast implants, especially when the breast skin is tight.

Breast Implant Shapes

What problems do shaped breast implants have?

Round breast implants are incredibly versatile, and remain the most commonly used breast implants in the US. While volume, diameter and profiles can be varied, round breast implant selection is simpler than shaped breast implant selection. Shaped breast implants require additional preoperative planning, because with more choices come more decisions.

Volume selection for shaped breast implants

Volume selection for shaped and round breast implants is similar in complexity. The volume needed to boost the starting volume to the desired cup size is determined after careful consultation with a Board Certified Plastic Surgeon. The goal is subjective, though there are physical limits as to what the body can maintain. Volume selection for shaped breast implants follows the same rules as for round breast implants. The main difference is how the volume is distributed. See Profile selection for shaped breast implants below.

Diameter selection for shaped breast implants

Selecting the proper horizontal diameter for shaped breast implants follows rules very similar to selecting the diameter for round breast implants. The diameter must be narrow enough to limit the over augmentation of the “side boob”, but wide enough to reduce the gap between the breasts.

The height of a shaped implant can be varied independently from the width. A shaped breast implant can have a height longer, shorter or equal to the width. Careful planning is used, and required, to select a height that fills the upper pole of the breast just high enough.

Profile selection for shaped breast implants

The projection of the shaped breast implant is greater in the lower half than in the upper half. Moreover, the profile can be varied independent of the diameter. This gives us more control over the shape of the breast, but also requires greater skill to obtain the best results. This type of selective projection helps with breast reconstruction after a mastectomy, and for some congenital anomalies like tubular breast deformities with constricted lower pole skin.

Mentor CPG - Contour Profile Gel Breast Implants

New problems created by shaped breast implants

Gummy-bear breast implants present several new problems not previously seen with round silicone breast implants. The simplest to understand is the changes in shape that occur when the shaped breast implant rotates.

If the shaped breast implant rotates, the larger lower pole can stick out sideways and fill the side of the breast. The result is not attractive. Shaped breast implants must be carefully placed into a precisely formed pocket to prevent rotation. Teardrop shaped breast implants are made with a rough, fuzzy, textured surface, to help prevent breast implant rotation. The goal is for the texturing to attach to the inside of pocket that forms around the breast implant, somewhat like Velcro.

The gel inside the gummy-bear breast implants can split or fracture. The result is a new type of breast implant malformation. Unlike the more liquid filled breast implants, the interior of a shaped breast implant can cleave in two and remain as two separate halves that never “flow” back together. Additionally, the semi-solid gel inside a gummy-bear breast implant can peel away from the inside of the breast implant’s shell. This may allow the shell to bunch up, or the divided halves of the interior gel to rotate independently, though the occurrence is rare.

Breast Implant follow-up studies

Like all implants approved in recent history, the FDA will require 10 year follow-up studies to check on the safety and performance of the shaped breast implants. I am a primary investigator for the current Allergan and Mentor breast implant follow-up studies. These long-term follow-up studies are over halfway completed, and are closed to new participants. Sientra’s follow-up study started this year, and I am currently enrolling qualified patients. With approval of the newest form-stable shaped breast implants this year, Allergan’s 410 Silicone Breast Implants and Mentor’s CPG (Contour Profile Gel) MemoryShape Breast Implants, look for the start of two more longitudinal long-term follow-up studies early next year.

More Breast Implant Information

Stay tuned to the San Francisco Plastic Surgery Blog for all the latest plastic surgery information, including updates on the newest breast implants. Additional information is available on my main web site, DrMele.com, and my SanFranciscoBreast.com web site, dedicated to aesthetic breast surgery in the Greater Bay Area.