Breast implants remain a popular plastic surgery procedure with over 350,000 women being implanted last year in the U.S. alone. Up until several months ago, only two U.S. manufacturers existed after many other producers folded from the breast implant controversy from the early 1990s. Allergan and Johnson & Johnson (subdivision Mentor) have maintained a duality on the breast implant market ever since. That was until several months ago when the Sientra company entered as a new supplier and now offers a third option for board-certified plastic surgeons when choosing breast implants for their patients.
Sientra is a new California-based company that received FDA approval for its breast implants in early 2012. An interesting question is why is a third company needed to supply breast implants and what do they bring to the table that the other companies don’t? The current providers certainly can fulfill all the needs of the U.S. breast augmentation market and, after all, a breast implant is just a breast implant isn’t it? Besides the always entrepreneurial and business reasons to provide any medical device, what makes Sientra implants different if anything?
There are several interesting twists that the Sientra company provides in its breast implant offerings. First, it does not at this time provide saline breast implants. They currently only offer silicone gel implants for both cosmetic augmentation and breast reconstruction. While a similar silicone elastomer shell (containment bag) is used for both silicone and saline breast implants, their initial product line is focused on silicone implants only. Whether saline implants will be added in the future remains to be seen. Secondly, it offers both round and shaped silicone breast implants. The shaped or teardrop implant can be very useful for those women that want to lessen the likelihood of too much upper pole fullness or have some tissue sagging that needs to be picked up by the greater location of the implant volume.
The third and most interesting distinction of the Sientra silicone breast implant is its standard use of an ultra strong cohesive gel in all of their implants. This type of silicone gel may be more recognizeable by patients of being of the ‘gummy bear’ form. The use of the term ‘gummy bear’ is an urban term that is not one any manufacturer uses or promotes. And while all three breast implant manufacturers have their formulations of a more cohesive or held-together silicone gel, Sientra is the first to be approved with this most cohesive gel. The implant can be cut in half, or pieces cut out of it, and only the most severe squeezing of any remnant will allow the gel to be extruded. Despite this degree of cohesiveness, the implant is remarkably soft and pliable. It is anything but stiff. And it comes in both a round and a textured implant shell.
The relevance of a very strong cohesive gel is more than just reducing the fear of silicone gel displacement and migration from a breast implant pocket. Such a formulation also reduces the risk of inadvertent rupture during the insertion through small breast incisions. While no one really talks about shell weakening from implant insertion, and how it may impact the rate of long-term implant rupture, it is always a concern. The advantages of a strong cohesive gel is seen in the very low five year rupture rates reported by Sientra in its FDA-submitted data of around 2%.
The availability of the new Sientra breast implants provides new options for breast reshaping in women. Such competition in the medical market is almost always good for implant quality and long-term results of which the patient is ultimately the beneficiary.
Dr. Barry Eppley
Indianapolis, Indiana