Breast augmentation depends largely, if not almost completely, on a prosthetic device to create its results. There is certainly a strong influence of surgical technique which is not to be underestimated but, in the end, without a device there would be no result. (fat injection techniques not withstanding) The evolution of breast implant device is a very interesting one that has included advances in the filler material (gel) and the enveloping shell composition and shape.

The very recent introduction of a new breast device manufacturer (Sientra) with their own implant versions (known by the urban term ‘gummy bear breast implants’) is both exciting as well as thought-provoking. What is different about these implants and how have they performed in patients? Since they have to have FDA-approval to be sold in the U.S., information from the clinical data submitted for that approval would be very helpful in determining how they perform and compare to existing breast implants.

Sientra received its FDA approval of their devices in early 2012 based on five years of prior testing. That clinical and performance information was reported in detail in a paper published in the November 2012 issue of Plastic and Reconstructive Surgery. The study comes from 7 different surgeons (centers) and looked at 1,788 patients (3,506 implants ) whom were implanted and then followed up for five years. Extracting from that information, primary breast augmentation patients numbered 1,116 patients and 2,230 breast implants. While the implants used a wide variety of different volumes, styles and implant locations (submuscular vs subglandular), the risk of implant rupture was 1.8%, capsular contracture was 9% and reoperation rates of 23.8% after five years. Surgeon satisfaction was over 99%.

This reported study is the largest breast implant study by patient volumes ever reported to date. This five year study of Sientra silicone gel breast implants shows that these devices are both safe and effective and work well in wide variety of breast uses including augmentation, reconstruction and revisional surgery. This is great news for women as new manufacturers providing any alternative choice that may even function better is always welcomed.

Besides the good functioning outcomes for Sientra breast implants, this data also provides some important and perhaps eye-opening information for women considering getting breast implants. Despite the wonderful results that they create, the sobering reality is that they are still synthetic devices and the incidence of complications such as capsular contracture, implant rupture and the need for revisional surgery is not rare. The low rate of rupture over five years (less than 2%) is very good but reoperation rates for elective breast augmentation is 16.6%. While many of these were for cosmetic reasons (size change, implant repositioning), that still means nearly 1 in 5 women had an additional surgery.

Breast augmentation surgery is very safe and incredibly effective and, while Sientra breast devices appear to be the best that are currently available, every women should be aware of the risks and potential need for revisional surgery. Most of the need for revisional surgery is not for implant failure reasons.

Dr. Barry Eppley

Indianapolis, Indiana

The options in breast augmentation have recently increased due to the emergence of a third breast implant manufacturer, Sientra. Sientra offers an extensive line of silicone gel breast implants with round and anatomic shapes and volumes up to 800ccs. They offer one type of silicone gel which is very cohesive and has often been described as being of ‘gummy bear-like’ consistency.

As an obligation of every silicone gel breast implant manufacturer once they are approved for commercial sale, Sientra is required by the FDA to conduct long-term studies of patients that have been implanted. Known as a post-approval study, patients must be followed for up to ten years after their surgery. This is an excellent way to see how well their implants perform, patient satisfaction and outcomes and reasons that revisional surgery may have been done. Sientra has called their post-approval study, OASIS. (Online Annual Sientra Implant Study)

To accumulate the number of patients that are needed for this long-term study, Sientra has enlisted numerous board-certified plastic surgeons across the U.S. to participate in this study. Plastic surgeons will enroll patients from their practice and follow them over the course of ten years after surgery. Patients will be compensated for their participation and will be able to report their experiences online.

Patient requirements, after having the implant surgery, include 10 annual online questionnaires and three office visits at years 1, 5 and 9 after surgery. Patients receive $50 for a baseline questionnaire filled out when signing up for surgery, $50 for each of the three annual follow-up visits, and $20 for each annual questionnaire filled out from years one through ten. These compensations for participating in the study could amount to a total of $ 400 over the course of the study. Payment can be received by check or gift cards from Amazon, Starbucks or Target. (fyi – these merchants are not sponsors or are affiliated with the Sientra Oasis study) Payments will arrive six to eight weeks following the completion of the patient’s questionnaire or office visit.

The OASIS study allows patients to participate and provide valuable personal information on their breast augmentation experience and will benefit  all women considering Sientra breast implants. Most patients should be able to find a participating plastic surgeon in their geographic area and, if not, they should contact the company directly for assistance in finding one.

Breast implants are not permanent or lifelong devices, regardless of the manufacturer. They will eventually fail and will need to be replaced in most patients. Sientra is well aware of this expected phenomenon which is why they offer lifelong implant replacement and financial compensation for surgery (up to $3600) and dual implant replacement if failure should occur in the first ten years after surgery. The OASIS study will help gather implant performance information that will enable improved implant designs and durability as breast device science continues to improve into the future.  

Dr. Barry Eppley

Indianapolis, Indiana

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   

The number of breast implant manufacturers has now officially increased to three.  Twenty years ago there were as many as six companies that commercially sold breast implants for both cosmetic and reconstructive surgery. But when the silicone gel breast implant moratorium occurred in 1991 and the legal and financial fallout ensued, the number of manufacturers was reduced to two. Allergan (back then known as McGhan) and Mentor (now part of Johnson & Johnson) have supplied most breast implant needs for US patients since then…and all silicone breast implants since 2006 when they were re-introduced for commercial sale.

The US Food and Drug Administration (FDA) on March 9, 2012 approved a new silicone gel breast implant made by Sientra, a Santa Barbara California-based company and an arm of the international company, Silimed. Like Allergan and Mentor, the new silicone breast implant made by Sientra is to be used for elective cosmetic breast augmentation in women aged 22 years and older and for breast reconstruction in women of any age.

The FDA’s approval of the Sientra implant was based on the study of nearly 1800 women who were followed for 3 years after implantation. Their safety was determined by comparing complication rates such as capsular contracture, reoperation, implant removal, asymmetry, and infection to those known for the other two manufacturers. Just like when Allergan and Mentor got their silicone breast implants approved in 2006, Sientra has a lot of due diligence to do going forward. This includes studying the implanted women in the clinical trial for up to 10 years after surgery, evaluate a much larger patient sample for potential autoimmune disease and breast cancer, and provide further control studies on the potential link between silicone breast implants and other rare diseases.

From a patient’s perspective what does Sientra implants offer that the other two manufacturer’s don’t? It appears that the options of differing implant sizes, shapes and a smooth and textured surface are similar based on a review of their product offerings on their website, as would be expected. There would not be anything novel about the silicone gel or implant offerings as the FDA has approved the new silicone implant based on the principle of equivalency. Something truly novel would require a lot more clinical information than a simple three year clinical trial. But an additional manufacturer provides another option for both plastic surgeons and patients and that competition may result in lower breast implant prices.

Silicone breast implant manufacturers have been in the news recently with the fall of the French-company PIP breast implants who allegedly used substandard industrial-grade silicone in their implants. These implants were never sold commercially in the US however. But as one company does down, another emerges.  

Dr. Barry Eppley

Indianapolis, Indiana