Invited Commentary

Eisenberg1 reports performing 6417 breast augmentations over 24 years. The vast majority (97.8%) of these devices were saline implants. Eisenberg irrigated pockets with a triple-antibiotic solution (cefazolin, gentamicin, and bacitracin) until 2020, when bacitracin was removed from the market. He does not mention whether another antimicrobial was substituted in its place. Eisenberg reports a Baker III/IV capsular contracture rate of 3.4% and only 2 breast implant infections (0.03%). Eisenberg used the same irrigation solution in all patients. A control group was unavailable. Accordingly, caution is needed when attributing a low capsular contracture rate to this antimicrobial regimen. It would be interesting to know his preferred treatment for capsular contracture and the recurrence rate. Eisenberg's experience compares with a capsular contracture rate of 5.9% for breast augmentation over a 10-year period in my own practice.2 My prospective clinical study was published in 2013, albeit with far fewer cases (n = 522). However, the proportion of saline implants (93.9%) was similar. Smooth implants were used exclusively. All implant pockets were irrigated with saline solution only. There were 2 infections (0.4%). Few studies report recurrence rates after surgery for capsular contracture. In 2016, I published a 20-year retrospective study of 75 consecutive patients with Baker III/IV capsular contractures treated in my practice with an open capsulotomy.3 Seventeen women (22.7%) developed a recurrent capsular contracture. Patients with intact implants had a lower (13.6%) risk of recurrence. Patients with ruptured silicone gel implants had a significantly greater risk of recurrence. This finding supports the observation that free silicone gel increases the risk of capsular contracture. A recent histological study confirms a link between the amount of silicone in the capsule and the risk of capsular contracture.4 Notably, there was no significant change in my capsular contracture rate (approximately 6%) after transitioning from Betadine pocket irrigation to sterile saline in 2000.5 Although bacteria and biofilm have long been suspected of causing capsular contracture, accumulating evidence is unsupportive of an infectious etiology.6 Despite using sophisticated microbiological methods, researchers have been unable to identify a responsible microbe or a bacterial profile associated with capsular contracture.6 Of course, if an infected biofilm were responsible for capsular contracture, a simple open capsulotomy would be expected to be uniformly unsuccessful because all of the capsule, and presumably the infected biofilm, remains in the patient. However, the success rate, 77%, is at least as high as other “gold standard” methods that include a capsulectomy, site change, and implant replacement.3 A role for acellular dermal matrix (ADM) in reducing capsular contracture risk has been challenged.7–9 Without knowledge of a responsible microbe, it makes no sense to use a shotgun approach in an effort to eradicate bacteria from an implant pocket.5,6 First, the antibiotic dwell time in the pocket is likely to be inadequate. Second, antimicrobial irrigation may be counterproductive.5,6 Eliminating harmless commensal bacteria might encourage the development of biofilm and an opportunistic infection—in accordance with the law of unintended consequences. Moreover, Betadine is cytotoxic and nonsterile. This antiseptic is unauthorized for irrigation of an open surgical wound. It is recommended only for topical use.10 Several systematic reviews,11–13 including a meta-analysis,11 do not support antimicrobial pocket irrigation. Burkhardt et al14 were the first plastic surgeons to irrigate breast implant pockets with Betadine, reporting this method in 1986, the year after Lineaweaver et al15 documented the marked cytotoxicity of povidone-iodine. In 1994, Burkhardt and Demas16 published another study showing that Betadine irrigation was actually ineffective in reducing risk. The referenced meta-analysis by Engels et al17 has problems with the data analysis that undermine its conclusions regarding the efficacy of antimicrobial irrigation.18 One problem is not recognizing contradictory evidence.19 Scientifically, one can accept contradictory data or reject it, but not ignore it. The best evidence is consistent and compelling. It is time to abandon antimicrobial irrigation in breast augmentation.5,6,10,18,19 Silicone gel implants are widely regarded as aesthetically superior to saline implants and less susceptible to rippling. This theory was tested in a prospective study, which included patient surveys, clinical evaluations, and ultrasound scans.20 Surprisingly, saline and silicone breast implants produced similar degrees of rippling. Leaner women experienced a greater incidence of rippling and folds. Saline implants hold an advantage at the time of surgery to treat a capsular contracture because silicone leakage is a nonissue.3,21 Nevertheless, many patients and surgeons believe that silicone gel implants have a more favorable feel characteristic. Plastic surgeons have turned up the intervention “dial” when treating capsular contracture (Fig. 1).3,7–9 A unilateral capsulectomy and insertion of ADM require more than 2 hours of operating time.23 Bilateral surgery takes 5 to 5.5 hours.24 The surgery is difficult and has been compared with operating through a mail slot.25 The total cost is comparable to the price of a small car.24 The complication rate is expected to be high and may be unreported.23 Capsulectomy plus ADM is presented as the option with the best chance of success and worth the extra cost.23,24 However, treatment failures occur.24 When this happens, external ultrasound is recommended, which is not known to be very effective (if it were, ultrasound would be used as the primary treatment modality). Patients with recurrences are left with no good surgical options. Redo surgery would involve even more breast trauma and even more expense. Conflict of interest is a well-known problem affecting studies of ADM.22,24FIGURE 1: Reconstructive ladder.22 Dialing down the intervention instead of dialing up. Open capsulotomy represents the simplest surgical treatment of capsular contracture. It is the first rung on the ladder and may be repeated. ADM, acellular dermal matrix.Plastic surgeons need to be much better stewards of our patients' finances.21,24 An open capsulotomy is not traumatic to the breast and can be easily repeated if necessary with almost no downtime.3 Patients do not embark on an endless cycle of capsulotomies.8 Capsulectomies may be reserved for pathologic or calcified capsules.21,22,24 Despite being in practice for 36 years, I have yet to perform a third open capsulotomy on the same patient.3,8 However, a third capsulotomy would not be a problem because the surgery is so innocuous, requiring approximately only 30 minutes of operating time.8 Insurance is not billed. There is no pathology fee because no tissue is removed. Most importantly, patients are not financially devastated. The cost is about the same as a high-end bicycle.24 Their breasts are not traumatized by an extensive, long procedure that includes off-label insertion of a foreign biological material that may contain donor DNA.7–9,24 Preserving the original capsule maintains control of the implant pocket, obviating the need for its replacement with ADM and formation of a new capsule.24 There is no logical basis for replacement of a nonpathologic capsule. Patients with capsular contracture are not promised that the treatment will be curative. Patients are informed that it is likely to be effective, recovery is easy, and the procedure may be repeated if necessary. Surgeons are ethically bound to present treatment alternatives to their patients.8 If a lesser procedure is effective and avoids more extensive surgery, recovery time, and complications, it is generally preferred.8 Eric Swanson, MDPrivate PracticeLeawood, KS