About 10 years ago, I was chosen to participate in an FDA study utilizing the then new anatomically shaped Inamed 410 silicone breast implant. The trial included initially about 25 surgeons across the USA. There was a short period of time after the initial patients were enrolled that more patients were able to be included. Over 900 patients in the USA were implanted with the shaped cohesive gel implants. Now the implant, although still seeking FDA approval, is again available for use by the initial group of plastic surgeons credentialed to use this new type of silicone gel breast implant. This imlant is different than what is being used presently in the USA, although it is quite popular in Europe where it has been available for some time. This implant is rather than round in shape, shaped like a breast, like a teardrop .Instead of sizing the patient with a volume like a number of cc’s, this implant has three different parameters that need to be adjusted based on the unique needs of each patient. The height, width and projection are all variables that can be adjusted to meet the needs of many different women’s breast shapes. We refer to this implant as a “form stable” implant. This means that if the shell of the impant is removed, the silicone material in the inside would still retain the intended shape of the implant.The lay description of the implant is the “gummy bear implant” relating its feel to that of the gummi bear candies. Having used this novel implant over 10 years now I feel I have a keen understanding of its merits. For the patient with ample breast tissue that has relaxed after childbirth or weight loss and settled to a lower position on the chest wall, this implant has the unique capability to internally replace the missing volume in the upper aspects of the breast and push the nipple and areola back up to a more youthful position on the chest wall.For the women with little overlying breast tissue and never having the skin of the breast being stretched before, the shape of this implant would be too overbearing and a round implant would still give a more flattering look. Since limited numbers of these implants will be available to be implanted, we will select those women who we believe will benefit most from the advantages of a shaped implant. I don’t expect the availability of this implant to last more than a few weeks.
