On March 09, 2012 the anxiously awaited and eagerly anticipated new breast implants were approved by the FDA.
Manufactured by the Sientra Corporation, the new breast implants give the patients and the plastic surgeons another option to consider when selecting an implant.
The traditional silicone gel implants and the silicone shell filled with saline implants are well known and have been available for a number of years. The new implants are quite different compared to the saline implants in terms of their structure.
The main difference between the older silicone implants and the new ones as far as the physical characteristics are concerned is the consistency of the new implants. The silicone gel filled implants, as the name states are made up of a silicone shell filled with silicone gel.
The new implants by Sientra are simply made by compressible silicone, hence also known as “Gummy bear” implants. The idea behind this innovation apparently is to avoid the risk of gel leak which in the past has been a concern.
It is to be noted here that the cohesive gel implants by Mentor were developed to avoid the gel leak problem. These implants are also known as “memory gel” implants. The gel will not leak and float around even if the implant is ruptured.
The technique for insertion for both the Mentor and Sientra implants remains the same. The initial three years study results seem promising in terms of the shape of the implants and prevention of ptosis or sagging.
The complications rates are quite similar amongst the three types of implants, the Sientra implants do feel firm on palpation compared to the Mentor implants.
FDA has approved these new implants for women of age 22 for breast augmentation and for breast reconstruction in women of all ages. The approval is conditional, as the FDA has asked the manufacturer to provide the long term data and safety records.
The satisfaction rate amongst women who have silicone gel implants is high; there is no satisfaction rate data available for the new implants.
In view of the comparable complications rate, relatively firm or even hard feel of the new implants and lack of patient satisfaction data, the silicone cohesive gel implants seem to be well positioned to compete with the new implants because they do feel softer, have a high patient satisfaction rate and the risk of gel leak and subsequent migration to distant locations is mitigated.
As the hype and anticipation is settling down, the time will tell whether the new implants carry any significant advantage over the previously available implants. Patients are well advised to discuss all the pros and cons of each Breast implant with their surgeon when they decide to opt for breast augmentation.
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