By ILYA PETROU, M.D.
Capsular contracture is the leading adverse event following breast implant surgery, and it is believed to result from subclinical bacterial colonization and the formation of biofilms within the breast pocket. The good news: A novel biodegradable antibiotic-impregnated sleeve that wraps around the implant proves to be very effective in preventing this feared complication.

“The significance of biofilms and bacteria as a main cause of capsular contracture in breast implant surgery appears to be underestimated. These biofilms are all too often responsible for the infections and commonly ensuing capsular contracture encountered in breast implant surgery,” says William P. Adams Jr., M.D., associate clinical professor of plastic surgery at University of Texas Southwestern Medical Center, Dallas.

“We know the use of triple antibiotic irrigations has resulted in a reduction of capsular contracture, and up-and-coming new and improved products such as a novel antibiotic-eluting product look to be even better in the prevention of this complication,” he adds.

PRODUCT HIGHLIGHTS
For several years, Dr. Adams has been researching the antibiotic effect of an antimicrobial-impregnated biodegradable wrap called the AIGISRx (TyRx Pharma), which has proven to effectively reduce the colonization of bacteria in breast implant surgery, thereby reducing the chances of developing capsular contracture. The product may be placed under the implant or placed like a sleeve that envelops the implant itself and can provide superior bacterial and biofilm coverage for approximately one month postoperatively.

The product was originally designed to fully surround the breast implant and has already proven its efficacy in multiple in vitro and animal trials with regard to preventing capsular contracture. The surgeon can place the implant in its entirety into the wrap, but the alternative design is placed under the implant (for use with textured implants), allowing implants to integrate with the surrounding tissue, particularly anteriorly. This integration may be wanted in textured implants, and it is particularly desired at the top and sides of the implant.

REVEALING RESEARCH
In order to establish the potential of the AIGISRx, Dr. Adams recently conducted a study in 16 rabbits, in which eight received an implant without the AIGISRx (control rabbits) and another eight received implants with the AIGISRx (experimental rabbits). In the experimental rabbits, the AIGISRx was placed only under the implant, not covering the top and sides of the implant, allowing for unimpeded integration between implant and breast tissue. All pockets at all surgical sites were then inoculated with a common bacterial strain. Surgical sites were followed up at seven and 28 days and were assessed one month post-procedure via culture, histology, applanation tonometry and capsular thickness.

Results showed that the control group demonstrated significant inflammation and infection, whereas the experimental group that received the antibiotic coverage with the sleeve had none. The cultures, histology and applanation tonometry exams demonstrated that the rabbits that received only the implant had a statistically significant higher capsular contracture compared with those in which the antibiotic sleeve was used.

“Even when only placed at the bottom of the implant in the pocket, the AIGISRx sleeve was able to prevent inflammation, infection, as well as capsular contracture, underscoring its novel antibiotic efficacy against those bacteria that cause biofilms in breast implant surgery,” Dr. Adams says.

CLINICAL NEED
The AIGISRx is a tyrosine-based polymer envelope imbued with tetracycline- and rifamycin-derivative antibiotics. It is fully resorbed within 60 to 90 days. According to Dr. Adams, the AIGISRx is the only antibiotic device in development of its kind, and because there is such a huge clinical need, he says he hopes the product will gain Food and Drug Administration clinical approval sooner rather than later.

The problem with standard antibiotic irrigations used by the vast majority of plastic surgeons is that bacteria are becoming increasingly virulent, as evidenced by the methicillin-resistant Staphylococcus aureus infections and vancomycin-resistant Enterococcus seen by physicians, Dr. Adams says.

Moreover, despite a wealth of clinical data, use of a proper antibiotic irrigation combination continues to be low, with the typical regimens surgeons commonly use (bacitracin or double antibiotic solutions, polymyxin B, gentamicin, or even diluted betadine solution being simply inadequate to cover the bacteria implicated in the formation of capsular contracture). Dr. Adams says he uses a mixture of betadine, cefazolin and gentamicin, or bacitracin, cefazolin or gentamicin. This triple antibiotic irrigation offers an excellent coverage and can reduce capsular contracture rates to levels four to five times lower than those indicated in published pre-market approval studies, he says.

“At a local level, this AIGIS product has shown to be very effective against all of the bacteria typically encountered in breast implant surgery, and is far more effective than standard irrigations,” Dr. Adams says. “We hope to make big progress with breast implant capsular contracture. This new technology will provide patients and surgeons with far better bacteria and biofilm coverage, and all one needs to do is simply place the product in the pocket and it is taken care of.”

LACK OF STANDARDIZATION
According to Dr. Adams, there is a lack of standardization and implementation of the correct combination of antibiotic formulas used in breast implant surgery. This could be due to failure of surgical staff to properly mix the antibiotics in the operating room, or lack of knowledge that more effective combination products are available.

“In the United States alone, 50,000 women a year will develop capsular contracture after cosmetic breast implant surgery. It is a big problem that causes significant morbidity to patients, and reducing it would be a huge advance for all patients undergoing breast implant surgery,” Dr. Adams says.

DISCLOSURES: Dr. Adams is a scientific consultant for TyRx Pharma.