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Data shows breast implant wrap significantly decreases capsular contracture rates

DALLAS Capsular contracture continues to be the most common complication seen in both aesthetic and reconstructive breast surgery, with current rates of 15 percent for saline and silicone implants at four to five years in FDA pre-market approval (PMA) trials. However, one expert tells Cosmetic Surgery Times his study data indicate that effectively killing the bacteria around the implant is key in reducing the rates of this complication.


Dr. Adams
BOTHERSOME BACTERIA — The etiology of capsular contracture is multi-factorial, but subclinical infection and contamination of the pocket with bacteria is probably the primary cause. These bacteria can cause enough inflammation to form a pathologic capsule around the implant and ultimately cause poor aesthetic outcomes post-operatively. Until now, surgeons have relied on orthodox antibiotic irrigation techniques as well as other aseptic techniques such as changing their gloves before handling implants.

"Reducing the colonization of bacteria in breast implant surgery is pivotal in reducing the chances of developing capsular contracture," says William P. Adams, Jr., M.D., a plastic surgeon in private practice in Dallas, Texas. "We are currently working with a very exciting novel device called the AEGISRx, an anti-microbial-impregnated biodegradable wrap produced by TyRx Pharma Inc. [Monmouth Junction, N.J.] that is designed to do just that," he explains. The AEGISRx is a tyrosine- based polymer envelope that "wraps" around the breast implant and is fully resorbed within 60 to 90 days. The antibiotic eluting wrap is imbued with tetracycline and rifamycin derivative antibiotics, an extremely broad-spectrum coverage that has proven to work very well in multiple studies. The wrap works like a sleeve that envelops the implant itself and can provide full antibiotic coverage for approximately one month post-operatively.

IRRIGATION ISSUES Though surgeons may try to culture the pocket, the results often are negative, which may be attributed to a bio-film layer surrounding the bacteria that makes them difficult to culture. Although surgeons use many different antibiotic irrigations to prevent capsular contracture, according to Dr. Adams, many — including bacitracin or double antibiotic solutions, polymyxin B, gentamicin or diluted betadine solution — may be suboptimal.

In a recent clinical study of 248 patients, Dr. Adams and his team developed a very effective antibiotic irrigation — a mixture of betadine, cefazolin and gentamicin, or bacitracin, cefazolin or gentamicin.1 According to Dr. Adams, this triple antibiotic irrigation provided excellent coverage. Indeed, as shown in clinical results, capsular contracture rates were four to five times lower than those in published PMA studies.

STANDARDIZED SOLUTION "Despite our work and publications, a lot of surgeons still use the suboptimal antibiotic irrigations and subsequently they still see higher rates of capsular contracture," says Dr. Adams. To reduce these rates, proper irrigation and proper irrigation/pocket preparation techniques need to be standardized in aesthetic and reconstructive breast surgery, which could be achieved with the AEGISRx concept, he asserts.

According to Dr. Adams, the capsular contracture wrap minimizes the variables, including antibiotic selection and handling, that can negatively affect the procedure. In his latest study, Dr. Adams used the AEGISRx wrap around smooth implants in 18 rabbits.2 Results showed that the implants treated with the AEGISRx product were pristine even though they were directly inoculated with the bacteria, including MRSA and vancomycin-resistant enterococcus — two bacteria that are very difficult to kill. There was no evidence of inflammation or pus in the pocket after 10 days' follow-up. When the capsules of the control groups and the experimental groups were compared at 10 days, there was a significant decrease in the opacity and thickness of the capsules in the AEGISRx wrap group compared to control even at that early stage.

"We are in the process of repeating the trial with textured implants because the application of the sleeve will be a little different," Dr. Adams explains. "Here, you do not want the sleeve to go all the way around the implant but rather only underneath it so that it can still react with the tissue anteriorly." He believes these studies show promise for the implant wrap to help reduce the rate of capsular contracture, which continues to plague breast surgery patients.

"In the United States alone, 45,000 women a year will develop capsular contracture after breast augmentation," he notes. "It's a significant problem that causes significant morbidity to patients and if we can reduce that, it would be a huge advance for all patients undergoing breast implant surgery."


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