There are three brands of silicone breast implants that women undergoing breast augmentation can choose from in the United States: Mentor, Allergan, and Sientra. Because breast implants are medical devices, their safety and use are closely monitored in the United States by the FDA.
Sientra, the most recent addition to the breast implant market in the United States, received FDA approval in 2012. For Sientra, the road to FDA approval began in 2002 when they established the largest silicone gel breast implant study to date, the Sientra Core Study.
Over 1,700 patients received Sientra implants as part of the study and were all monitored for a ten year period. In April of 2018, several of the top breast surgeons in the country took a deeper dive into the study’s results and published their findings in Plastic and Reconstructive Surgery, the Journal of the American Society of Plastic Surgeons.
“What was great about the study is that it showed a great safety profile for Sientra silicone breast implants,” shares Dr. Bradley M. Calobrace, one of the authors of the article. He adds that as a result of the study’s findings, “patients should feel more secure that these implants are very, very safe.”
Sientra Knows Breast Implant Safety Starts with Surgeon Selection
Sientra’s implants are available exclusively through board certified plastic surgeons. This sets Sientra apart from the other two implant companies who sell implants to any surgeons, regardless of training or board certification.
The idea behind Sientra’s unique sales philosophy is that by limiting access to their product to highly trained and experienced surgeons, they are contributing to the safety of the patients who receive their implants. “If you’re getting a Sientra implant, you know a qualified surgeon is doing it,” points out Dr. Calobrace.
Implant Safety Should Always be Monitored Long-Term
Even if you are not part of a long-term breast implant study, it is important that you continue to follow up with your plastic surgeon annually.“We are looking to make sure they don’t have breast cancer and that they’re not developing capsular contracture,” points out Calobrace. “There’s also a very rare incidence of patients getting a lymphoma that’s somewhat associated with breast implants. Patients need to be evaluated by a plastic surgeon so we can make sure and keep them safe.”
The Sientra ten-year study had zero reported cases of BIA-ALCL, the rare lymphoma that has been linked to breast implants in a small number of patients. The lymphoma can, however, be treated and overcome with early detection. Even though the risk is very low, it is important to keep your plastic surgeon aware of any changes in your breast, especially any unusual swelling that could indicate the presence of fluid around the implant.
Did You Know Breast Implants Come with Warranties?
When you are considering your options for breast implants, it’s smart to compare the warranties. While the risks of complications like capsular contracture are low, it is nice to have peace of mind that you are covered if a complication does arise in the future.
Breast implants sold in the United States have long come with a limited time warranty. Today, all three companies offer lifetime replacement of implants in the case of implant rupture. While Mentor and Allergan offer $3,500 towards the cost of revision surgery to replace a ruptured implant when it occurs in the first ten years, Sientra offers $5,000 towards the cost of surgery for twenty years following breast implant placement.
The differences in warranty between breast implant manufacturers also extends to coverage for capsular contracture.
Understanding Capsular Contracture
When the breast implant is placed inside of the body, the body responds by forming a thin layer of scar tissue around the implant. In the majority of breast implant cases, the scar tissue is so thin and soft that you cannot feel it and do not even know it is there. In a small percentage of cases, that scar tissue becomes thick and tightens around the implant, making the implant feel hard to the touch. This is known as capsular contracture.
There are no implants on the market that can completely eliminate the risk of capsular contracture. While there are steps skilled surgeons take during surgery to reduce the risk of capsular contracture, there is no known cause or method to prevent it entirely.
Sientra will replace the implant at no cost if capsular contracture occurs in the 20 years following surgery, which is double the length of the capsular contracture warranty offered by either Allergan or Mentor. If you have a Sientra implant and experience capsular contracture in the first two years, Sientra will also provide $2000 towards the cost of revision surgery, in addition to replacing the implant at no cost.
“I really like the idea of industry getting behind the safety profile of their implants, and putting their pocket book where the results are,” says Calobrace. “I think this is really a move in the right direction for breast implant surgery.”