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Follicular unit hair transplantation has a favorable safety profile, thanks in part to the remarkable healing qualities of the scalp and use of proper aseptic and surgical techniques. As with all surgeries, however, a number of complications can occur.

Follicular unit hair transplantation has a favorable safety profile, thanks in part to the remarkable healing qualities of the scalp and use of proper aseptic and surgical techniques. As with all surgeries, however, a number of complications can occur.

Follicular unit hair transplantation has a favorable safety profile, thanks in part to the remarkable healing qualities of the scalp and use of proper aseptic and surgical techniques. As with all surgeries, however, a number of complications can occur.

MRSA infection after hair restoration surgery is currently not a major issue," Dr. True says. "Results of one survey found a prevalence rate of about one in 2,000 cases, so that a surgeon who performs 500 cases per year may expect to see one such infection every three to four years. However, it is important to be aware that it can occur, and to consider an in-office source if a cluster of cases occurs."
POSTOPERATIVE CARE The need for perioperative antibiotic prophylaxis to avoid infection after hair restoration surgery is somewhat controversial. There is no evidence to support its routine use. In the interest of practicing defensive medicine, however, E. Antonio Mangubat, M.D., says he gives all patients the option of receiving a five-day course of cephalexin, beginning with the first dose given prior to surgery.

"If the patient was not offered an antibiotic, gets an infection with a poor outcome and the case turns into a malpractice suit, the surgeon will likely be held at fault," says Dr. Mangubat, a board-certified cosmetic surgeon in Seattle.

GROWTH AND LOSS ISSUES Poor growth is a relatively common occurrence after follicular unit transplant surgery. Prevention is the best management for this complication, and that requires understanding of the multiple possible causes, Dr. True says.

Compromise of the vascular supply in the receptor area is a major factor, and this may be a particular issue for patients who are smokers or diabetic. Due to its vasoconstriction properties, epinephrine use in the tumescent anesthesia solution may also play a role.

"The effect of epinephrine on the vasculature has been shown to persist for one to two days after injection, and so surgeons might be especially careful about eliminating it from the tumescent anesthesia solution for patients who are already at risk for vascular issues," Dr. True says.

Graft trauma can also underlie poor growth, and that may be a consequence of poor dissection techniques, desiccation after extended time out of body, rough insertion or over-cutting, which may be done to increase the number of grafts obtained. Infection and inflammation of the receptor area are other factors that can lead to poor growth.

SHOCK LOSS

Shock loss or shedding of hair is something that must also be included in the informed consent discussion with any patient who has existing native or transplanted hair in the receptor area.

"Patients who have miniaturized native hair are especially vulnerable to this event and must be warned about it as a possible risk," Dr. True says.

There are also a number of factors that can lead to shock loss. Surgically induced direct injury to the follicles is one possible cause.

"It is generally thought that when working in between existing hairs, coronal incisions carry a greater risk of causing follicular damage. In this situation, sagittal incisions may be preferred," Dr. True says.
Vascular disruption may also be a factor in shock loss, so use of epinephrine in the tumescent solution should also be considered carefully in procedures where there is existing hair in the receptor area. Dense packing into the area of thinning hair by trying to insert a large number of follicular units close together can also be a cause. Stopping existing medical treatment for hair loss prior to surgery and failing to resume it post-transplantation may also contribute to shock loss.

DONOR CLOSURE CONTROVERSY

Loss of hair can also occur at the harvesting site, particularly if the donor wound closure is too tight. Decisions on the donor strip width and whether the edges of the ellipse can be brought together without too much tension involve a judgment call. However, surgeons should realize that if caught in a situation where there is insufficient laxity to achieve a tension-free closure, partial closure and allowing the remainder of the wound to heal by secondary intention is better than forcing full closure, which can compromise the vascular supply and cause hair loss, Dr. Mangubat says.

If a wide, visible donor site scar cannot be excised because of excess tension, other options should be considered. Transplantation of the scarred area may be attempted, although the yield is often reduced. A more aggressive but more reliable method utilizes tissue expansion followed by excision and a tension-free closure. If some laxity exists, serial excision performed either by taking punch grafts or with multiple linear excisions can be successful.

The career of Thomas Biggs, M.D., is as entwined with the modern evolution of breast implants as are the staff and snakes of the caduceus. He trained under Thomas Cronin, M.D., who — along with Frank Gerow, M.D. — was responsible for developing the first modern-day silicone gel breast implant in conjunction with Dow Corning.

Since then, he has been involved in more than 8,000 breast implant procedures throughout a career that has spanned more than 40 years. Today, the semi-retired Baylor College of Medicine clinical professor of plastic surgery travels the world lecturing about the evolution of breast implants and performing surgery in far-flung locales, from Brazil to India and everywhere in between.

Dr. Biggs' primary message when lecturing about breast implants is that "They are not a way to get a boyfriend back or to keep a husband interested. The breast is the external symbol of a woman's gender, so anything that we can do to make the breast more appealing to a woman enhances her feeling of her own womanhood and gives her more self-assurance." This, he says, is what he told his audience back in 2000 when he was among a hand-picked group of physicians who were invited to the Vatican to discuss their medical specialty.

"The Vatican decided to have an assemblage of all of the world's medical knowledge and brought physicians in from across the globe. They selected six plastic surgeons, and I was one of two from the United States, and I was asked to talk about the evolution of breast implants," Dr. Biggs says. "I stressed my belief that the sole purpose of being a physician should be to make a person's life longer or better or both, and explained how breast implants make women's lives better."
IN THE BEGINNING While the history of modern breast implants starts with Dr. Biggs' colleagues Dr. Cronin and Dr. Gerow, attempts to enhance the size and/or shape of the breast weren't new — efforts were made even in the 1890s. "Early attempts ranged from very, very bad to not good, and they all failed," Dr. Biggs says.

The implants that immediately preceded Dr. Cronin's and Dr. Gerow's "natural feel" implants included sponge prosthetics made of Etheron (polyether foam sponge), Polystan (polyethylene tape) and polyethylene. Within a year, all of these resulted in capsular contraction, which collapsed the sponge and deflated the implants by 25 percent or more. "Then," Dr. Biggs says, "in 1962, Cronin and Gerow created an implant made out of silicone."

The inspiration for the early silicone gel implant was a blood transfusion bag. Early blood transfusion vessels were made of glass. During the silicone gel implant's developmental stages, Dr. Cronin visited a blood bank, and upon feeling the new and improved flexible plastic bag that contained the blood, he observed that it felt like a breast, according to Dr. Biggs. The rest, as they say, is history.

Silicone was used to make a thin, flexible "fabric bag," and also to make a gel-like substance with which to fill it. "The cohesiveness of the gel could be altered so that it could be very thin or even solid," Dr. Biggs says. "They created one small implant and put it into a dog and the dog was fine, so then they implanted it in a person and she got along just great. So then we began to put it into more and more people," he says, noting that "In those days, there was very little regulation, so there was minimal obstruction to its being manufactured and sold."

Dr. Biggs recalls that Dr. Cronin and Dr. Gerow thought the implant had a great future, because it was virtually nonreactive. Dr. Biggs and his colleagues encountered a multiplicity of problems throughout the developmental phase, but, ironically, the only one that persisted — and resulted in almost every early case — was fibrous capsular contraction.

"The body needs to isolate a foreign material from itself, and the wall that built up around the implant would contract and make the implant feel hard. One of the things that we did to minimize this problem was to coat the implant with polyurethane. Once we did this, the incidence of capsular contraction dropped to almost zero," he says.

SILICONE SORROWS

 Meanwhile, a handful of cases of cancer of the liver occurred in animal studies of the polyurethane-coated implants, and the manufacturer elected to forgo additional studies, stopped manufacturing the implant and went out of business. "I had 600 cases with the polyurethane-coated implants in humans, and none of my patients got cancer of the liver, nor did I ever hear of anyone who did," Dr. Biggs says.

Other manufacturers created similar implants and coated them with simulated polyurethane. This, Dr. Biggs says, is what became known as "texturing." While the majority of patients were happy with these silicone implants, according to Dr. Biggs, a news story in the early 1990s linking silicone breast implants with autoimmune diseases set the evolution of breast implants on an almost 20-year detour. This development culminated in the largest class-action lawsuit in medical history, with $4.2 billion awarded to women with silicone gel implants.

"When the expose came along saying that silicone implants may be causing autoimmune disorders, the FDA (Food and Drug Administration) prohibited the use of silicone implants filled with silicone, but they allowed us to use a silicone implant filled with saline," Dr. Biggs says. "What is paradoxical is that the FDA allowed us to use silicone implants filled with silicone gel for reconstruction in patients who had cancer, but their use was prohibited in healthy women."

After the FDA's moratorium, silicone gel implants were available only for patients enrolled in the Special Adjunct Study, which included patients who had mastectomy or severe developmental deformity, or those with failed augmentation following saline implants.
During the moratorium, although many women were happy with saline implants, there were some problems, Dr. Biggs says. "They didn't feel as natural as silicone gel implants, and there was a propensity to leakage problems," Dr. Biggs says. "They leaked because of fold flaws, and because of failure of the valve through which they were inflated. We had an annual 1 percent to 5 percent deflation rate."

In 1999, after years of retrospective outcomes analysis, the FDA concluded there was no evidence showing that silicone gel implants played a substantial role in autoimmune disorders. "But," Dr. Biggs says, "that didn't represent an automatic reintroduction of silicone implants. The FDA put very stringent demands on the manufacturers as to what they had to do to show that use of these 'third-generation' implants was justifiable."

The third-generation implants have a triple-layer shell that prevents leakage, and the gel is more cohesive — so much so that even if it were to leak, the gel would stay put, Dr. Biggs says. "We now have a silicone gel implant that we are certain is safe, and last year the FDA decided that it was acceptable to once again offer silicone gel implants for augmentation," he says.

WHAT'S AHEAD

 Shaped implants represent the fourth generation of breast implants. For patients who lack sufficient breast tissue in the lower pole, as well as for mastectomy patients, these shaped implants offer significant benefits, according to Dr. Biggs.

"Most patients will be adequately treated with a round implant, but there is a subset of patients who will definitely benefit from a shaped implant," he says. "One of the deficiencies of the shaped implant is that if it rotates, it creates a significant deformity, whereas the round implant does not. To prevent it from rotating requires a much more careful dissection of the space into which we put the implant. That said, if a woman has deficiency of tissue in the lower pole, she can benefit greatly from the advances that we have made with these shaped implants, even though it is more technically demanding and more costly," he adds

Achieving a successful outcome after vaginal tightening surgery requires operating on the right woman for the right reasons using the right procedure. Fulfilling all three parts of this equation depends on conducting an in-depth preoperative consultation so the surgeon understands the woman's issues and desires, and the patient appreciates what the surgery can and cannot deliver, said Michael P. Goodman, M.D., at the International Society of Cosmetogynecology Workshop presented by the American Academy of Cosmetic Surgery in Orlando, Fla., in January.

There are many reasons why women seek consultation for a vaginal tightening procedure. Goals that represent legitimate indications for surgery include desires for an enhanced sexual experience, more friction with coitus or for enhancing a partner's sexual experience. For some women, there is also a cosmetic reason, such as a feeling of being "open and vulnerable." Motivations that are inappropriate include a desire to satisfy the request of a sexual partner or to correct sexual dysfunction.
"It is incumbent on us to find out why the patient is seeking surgery and understand her issues, to determine if surgery can be expected to deliver the expected results. If a patient is trying to turn around a poor sex life, save a crumbling relationship or overcome a true sexual dysfunction, the surgery will not succeed," says Dr. Goodman, a board-certified gynecologist and private practitioner in Davis, Calif., specializing in female genital plastic surgery, integrative gynecology, and menopausal and sexual medicine.

"Vaginal tightening procedures enhance sexual function, but will not cure sexual dysfunction. Appropriate candidates are women who are basically happy in their relationship but would like to improve it," Dr. Goodman explains.
COMMUNICATION, EDUCATION To screen for sexual dysfunction, surgeons must be comfortable talking about sexual issues with their patients. This requires educating oneself and practicing while being at ease using the vernacular when discussing sexual relations.

"Uncovering problems requires that a woman feels comfortable with you and trusts you. Surgeons don't have to be a certified sex therapist, but they must not be embarrassed talking about sex," Dr. Goodman says.

Information and education can be acquired through sponsored meetings and publications issued by a number of organizations, including the International Society for the Study of Women's Sexual Health, the Society for Sex Therapy and Research, and the Society for the Scientific Study of Sexuality. Psychosexual survey instruments, including the Arizona Sexual Experience Scale, Female Sexual Function Index, and the Female Sexual Distress Scale, may be useful screening tools. While they are not necessary, they can be helpful in situations where it is unclear whether the patient has sexual dysfunction.

"The dictum, 'Measure twice, cut once' does not apply only to surgical technique, but also to emotional and psychosexual screening, as well," Dr. Goodman says.

HELPFUL QUESTIONS Dr. Goodman suggested a series of questions that should be asked to uncover sexual dysfunction. These include:

What prompted your decision to seek vaginal surgery?
With whom have you discussed this, and what did they say?
Are you orgasmic?
Has the frequency and/or intensity of your orgasms diminished, and why do you think this has occurred?
"However, surgeons should realize — and educate patients — that only about 40 percent of women who are orgasmic experience climax via penile stimulation alone," Dr. Goodman says.

During the consultation, the surgeon should also explore how patients feel about their body in terms of its shape, size, attractiveness and responsiveness, and explore relationship issues. Some women will be in between relationships and seeking to reinvent themselves in preparation for a new relationship, and that does not mean they have a body dysmorphic disorder.

"However, the surgeon must be able to distinguish these individuals from women who have already had multiple procedures and are seeking an unobtainable goal, and instruct women appropriately that surgery will not fix a relationship issue," Dr. Goodman says.

Patients who are thought to have sexual dysfunction should be referred to an appropriate source for therapy rather than simply turned away. Ultimately, after successful treatment of an existing sexual dysfunction, some of these women may come back seeking surgery to enhance sexual function.

Dr. Goodman also encourages surgeons who are performing vaginal tightening procedures to make contact with a pelvic floor physical therapist in their area. He notes that his fee includes three sessions with the therapist.

"The best repair in the world is only as good as the muscular function. The surgeon can bring tissues together, but a woman must be in touch with the function of the muscles so that they will work and the surgery will be a success," Dr. Goodman says.

The best strategy for dealing with difficult patients is to avoid them in the first place, and success in that regard involves careful patient selection and multipronged efforts to provide the patient with a positive experience from beginning to end.

Under influence from his mentor, Richard Webster, M.D., Dr. Tobin says he decided in 1982 to limit his practice scope to cosmetic surgery. Among the many pearls he learned from Dr. Webster was that the way surgeons deal with their patients is just as important as their clinical acumen and surgical skill.
"There are many things that make patients dissatisfied," says Dr. Tobin, a private practitioner in Abilene, Texas, and clinical associate professor of surgery, University of Texas Southwestern Medical Center, Dallas. "It could be something you did, something you didn't do, or something they think you didn't do right, and the fact is, we don't always accomplish what we hope to in the OR."

"However, treating the patient well from the initial consultation until the end of the postoperative care will build a positive doctor-patient relationship that helps in preventing patient dissatisfaction, or dealing with it successfully if it occurs," he adds.
Treating patients well is a responsibility of the surgeon, but it also requires a supportive staff. Assuring the latter element is in place means making certain office personnel know they are appreciated and allowing them to develop to their full potential.

"Remember, your staff is your most important asset. They really run the practice and play a large role in taking good care of patients. This, in turn, will help to keep patients coming back," Dr. Tobin says.

LISTEN, LISTEN, LISTEN In their interactions with patients, surgeons must be cognizant of their communication skills, paying attention to their verbal and nonverbal language. Letting the patient talk without interrupting and listening with genuine interest are critical. It is also important not to talk patients into procedures they are not seeking in the first place.

"If you push for more, the patient agrees, and something goes wrong, you will be considered completely at fault," Dr. Tobin says, "whereas the patient is likely to be far more understanding if there is a problem with something the patient asked you to do."

In the initial consultation, surgeons should be watching for red flags that suggest a patient may not be a good match to the practice. As described by Vic Narurkar, M.D. (Cosmetic Surgery Times, March 2006), some signs of a "problem" patient include obsessive-compulsive behavior, a history of "doctor shopping," excessive rudeness or flattery, litigiousness and sudden whims. To this list, Dr. Tobin adds patients who bargain.

"You want to avoid patients who send bad vibes, but be diplomatic in declining their request for surgery, perhaps stating you don't think you would be the best surgeon to do what they need," Dr. Tobin says. "Don't flatly refuse to operate, because if you treat them with kindness and respect, they still may appreciate your thoughtful consultation and refer other patients."

ENSURE EDUCATION
Ensuring the patient is properly educated about the procedure and its possible outcomes are also essential in preventing dissatisfaction, but this seems to be a weak area for some cosmetic surgeons. Dr. Tobin emphasizes that the information must be presented in terms the patient understands and be reinforced with additional resources (for example, online information or written literature), keeping in mind that patients will retain only a small percentage of the verbal information they receive in the office.

In his practice, Dr. Tobin uses materials developed in-office rather than stock literature, and presents slide shows highlighting outcomes of past patients. However, he limits the content of the latter to cases achieving average results. He is also careful that patients understand the risks and limitations of the proposed procedures.

"Promise less and deliver more, and you will come out ahead of the game," Dr. Tobin says.

In Dr. Tobin's practice, a follow-up letter is sent after each consultation, thanking the patient for coming in and reviewing the recommendations. It also asks the patient to read the literature they were given, and encourages them to come back or call with any questions.

"We rarely schedule surgery at the time of the consultation. Instead, it is better to allow patients time to go home and think," Dr. Tobin says.

Patients who have decided on surgery are also given the consent form in advance, not on the day of the procedure, so they have time to read it and develop questions. And on the day of the procedure, Dr. Tobin and other OR staff visit patients before surgery.

"Getting patients into a relaxed state when they go into the operation means they will be more relaxed when they come out," he says, noting that it may also be helpful to "bring your dog to work."

"My patients love to see my dog, and having my dog around helps my mood as well," he adds.

OPERATE OPPORTUNISTICALLY
In the OR, Dr. Tobin says his motto is "operate opportunistically," which means modifying the surgical plan as necessary to avoid unnecessary risk. With that in mind, he also advises surgeons not to be among the first to try every new procedure.

"Surgeons are most likely to experience major complications after they've returned from a major meeting. Don't be in a rush to go back and try what you've just heard about. Wait for the procedure to stand a test of time and realize that if anything goes wrong, you may not have the experience to know how to rectify the situation," he says.

If complications occur, or if the patient is dissatisfied with the outcome for another reason, Dr. Tobin advises acknowledging the complaints and dealing with them, expressing one's personal regret rather than arguing with the patient.

"Patients can be forgiving if they think you really care and are trying to satisfy them," he says.
"Saying 'I'm sorry' does not generate a lawsuit or admit liability, but rather bonds you with your patients, especially if you reassure them you will help to correct a problem," he says. "Still, be careful about what is written in the chart."

Patients who are still unhappy can be encouraged to seek a second opinion, but the surgeon should be proactive in recommending a colleague expected to be supportive and circumvent the patient from picking someone who may be one's adversary. Dr. Tobin notes that except for the OR expense, he waives any charges for correcting a complication and will also refund the entire fee if a patient remains unhappy despite all of his best efforts.

"Giving dissatisfied patients their money back is not a settlement or admission of negligence, but says you didn't achieve what the patient hoped you would. Remember, as a bottom line, keeping your patients happy is the most certain way to keep yourself happy. Achieving self-satisfaction along with satisfied patients are the surest ways to build and maintain a long and successful practice," Dr. Tobin says.

Fat grafting has been around for several decades and has become an extremely popular surgical procedure. This is due to the procedure's relative simplicity, as well as the positive aesthetic outcomes achieved. Following simple guidelines and practices tested over many years can assist in maximizing cosmetic outcomes while minimizing unwanted adverse events.

Whether enhancing the breasts, augmenting the lips and malar area in facial reconstruction, or sculpting and accentuating body contours where desired, fat grafting is a state-of-the-art technique that is slowly but surely eclipsing other surgical techniques. The procedure involves taking fat from one area of the body and injecting it into another. This autologous fat transplantation technique has the best chances of effectively and naturally restoring depleted fat areas, and it circumvents the issues of tissue compatibility typically encountered with other volume-enhancing products and techniques.

"Fat grafting has two major indications — namely, to increase the volume of the target area and to improve the quality of the skin, as a successful procedure will impart a natural fullness and plumpness to the skin," says Antonio Fuente del Campo, M.D., plastic surgeon and director of the Aqtuel Plastic Surgery Clinic, Mexico City. "In the proper indication, all cosmetic patients can benefit from the technique, and, oftentimes, fat grafting can prove to be the superior choice compared to other options, such as silicone injections, which very often can result in an aesthetic fiasco."

Fat grafting can be used to reverse the aesthetic injuries resulting from therapeutic irradiation treatments, improve scars and skin-grafted areas, and support the reconstruction and correction of an adverse reaction to "black-market" silicone injections, according to Dr. Fuente del Campo.
"When correcting aesthetic surgical blunders resulting from poorly executed silicone enhancement of the lips, it is imperative to first remove as much of the present silicone as possible from the lips. In such corrective and reconstructive cases, I apply the principles of liposculpture by taking fat from the areas where the fat is redundant (donor area) and injecting it in the defect area," Dr. Fuente del Campo says.

HOW IT WORKS

The injected fat stimulates neovascularization, increasing the vessels net and the blood supply, which in turn helps to quickly repair and restore the target area. Stem cells laden with growth factors are considered one of the most valuable constituents of the fat tissue aspirate, as they play an intricate role in tissue reconstruction. Therefore, it is critical that the aspirate is carefully harvested, processed, refined and prepared so as to avoid washing out these vital growth factors.

According to Dr. Fuente del Campo, one of the keys to maximizing the chance of survival of the aspirated fat tissue is to harvest and place the fat aspirate in small aliquots instead of larger clumps of fat. This careful step will minimize trauma and help to avoid necrosis of the transplanted fatty tissue, as well as the formation of liponecrotic cysts.

"It is important that the surgeon carefully considers the purpose of the lipo-injection, the area where it will be injected and the amount to be injected," Dr. Fuente del Campo explains. "The diameter of the cannula is also important in order to be able to aspirate the appropriate size of fat drops. These careful steps and precautions will help to ensure a better perspective for long-term and more predictable results."

OTHER OPTIONS

Currently, several other artificial injectable products are available that are geared toward enhancing and improving volume. However, according to Dr. Fuente del Campo, they can only be used safely in small amounts. These products — permanent implants or injectable silicone — will never become part of the body and will invariably be prone to a scarring process. This can lead to these devices being palpated through the skin or even extruded from the body. Autologous fat is exempt from such adverse events and is considered by many as the choice procedure for volume enhancement.

"There is no other product which can improve the quality of the skin as autologous fat. The fat aspirate, which is injected in the superficial subcutaneous plane, enhances the blood supply of the skin, improving the color, thickness, elasticity and texture naturally," Dr. Fuente del Campo says.

START SMALL

 Dr. Fuente del Campo says newcomers to the fat grafting technique should start by injecting only small amounts of fat in reconstructive cases. After they gain experience and more confidence, they can move ahead and employ the technique for cosmetic indications. Surgeons must also remember to never over-correct, as it is always easier to return to the target site and add more fat tissue than it is to remove excess injected fat.

"There are no disadvantages of the fat grafting procedure if it is well-indicated and well-executed. Like any common injection, the procedure should be done properly so as to avoid local infections," Dr. Fuente del Campo says.

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.