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Mentor’s Breast Implant “MemoryShape” Gets FDA Approval

July 1st, 2013 Miguel A. Delgado Jr, MD

San Francisco, CA-When the FDA called a moratorium on silicone breast implants in 1992, the road back to approval for these implants was very slow. The scare that the implants might be causing autoimmune diseases and various other complications made the implants unavailable to all except patients undergoing breast reconstruction surgery or breast augmentation revision surgery. That left women who wanted breast augmentation, saline breast implants as their only choice.

Mentor's MemoryShape Implant

Mentor’s MemoryShape Implant

 

After many clinical trials, silicone breast implants were deemed safe and returned to market in 2006 for women 22 years of age and older. The approval comes with the understanding that the FDA recommends (not requires) that women have an MRI after three years of implantation and then every two years after that. The MRI is to watch for what is referred to as “a silent leak”. Within just a few years, the popularity of silicone breast implants surpassed saline implants by 80%.

Conducting trials for breast implants is very challenging for manufacturers, surgeons, patients and the surgeon’s staff. Once the excitement of the surgery has worn off, it is difficult to keep patients that are not having any issues to come in for their yearly visits, even with incentives offered by the manufacturer. In many cases, the patient may have moved out of the area, or there may have been staff turnover in the surgeon’s office and compliance starts falling through the cracks, making consistent follow up for 5 to 10 years daunting.

In anticipation of future FDA approval for silicone breast implants, manufacturers continued to develop new types of implants and started to conduct clinical trials. The “gummy bear” which is a colloquial term to describe the firmer anatomical cohesive gel implant, had trials beginning in 2001.

The highly cohesive implant made by Mentor is called “MemoryShape” and has been available for the past 10 years in 70 countries but not in the United States, until now. The “MemoryShape” implant has a tapered “teardrop” shape. It is thinner at the top and gently slopes to a fuller projection at the bottom. The shell has a subtle imprint; “Siltex Texture” designed to keep the implant in place.

The appeal of the anatomical shaped cohesive breast implant for most women is for a more natural look, youthful firmness and due to the high cohesiveness, they are less likely to ripple, rupture or leak throughout the breast tissue.  For the downside, many women do not like the firmness or the risk of rotation of a teardrop shaped implant leaving them looking deformed.  Also, it is very difficult to insert the implant through an incision around the areola, the recommended approach is the inframammary fold  which requires a longer incision. The breast implant cost goes up by approximately $1000.  The anatomical shaped implant does not work well with  breast revision  surgeries or for the woman who desires larger and/or softer implants and for the woman having a breast reduction with a lift and implant, will most likely be happier with the standard gel implants.

Allergan got FDA approval for their “gummy bear” implant, Natrelle 410 in February 2013, and Sientra got approval for their anatomical cohesive gel implant in March 2012.  Mentor is the only company that manufactures their implants in the United States, but all implants available in the United States are manufactured with the same strict guidelines.

Mentor LogoThe anatomical cohesive gel breast implants vary in; their firmness, their shape and dimensions. They all have a textured shell to help the implant from moving out of place or rotating. The different manufacturers made their implants with different degrees of cohesiveness and they vary on how much gel they put into the shell. The more cohesive the gel is and the more they fill the shell, the better it will hold its shape, and is more resistant to shell folds, but will not feel as soft.

Since FDA approval of silicone gel breast implants in 2006, women have many more choices. There is fierce competition amongst breast implant manufacturers. Each manufacturer has its own philosophy for advantages and disadvantages for the different possible aspects of breast implants.

In deciding to have breast augmentation surgery, the patient needs to review all risks and possible complications with her surgeon and understand that implants are not lifetime devices. It is important to be aware of the fact that revision surgery will most likely be necessary at least once in a patient’s lifetime, and maybe more.

Surgeons have their own preferences and experiences with different implants. It is more important to find a Board Certified Plastic Surgeon that you trust, to help you determine what type of implant is best for you. Be sure to request to see many pictures, before and after breast implants.

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