Will 1-stage implant salvage after periprosthetic breast infection ever be routine? A 6-year successful experience.

BACKGROUND
Concomitant with the recent increase in breast augmentations has been an increase in periprosthetic infections necessitating further surgery. The conventional treatment of periprosthetic infections has been a multistage procedure involving explantation, control of infection, and reimplantation.


OBJECTIVES
The authors describe a 1-stage salvage procedure for the management of periprosthetic infections. This technique may become the standard for managing infection following cosmetic breast surgery.


METHODS
The authors performed a retrospective review of all patients who had periprosthetic infection following cosmetic breast augmentation. The treatment included explantation, sequential cleaning of the wound, and immediate insertion of a new prosthesis and drain. All patients received intravenous antibiotics postoperatively. Of 3012 patients undergoing primary breast augmentation, periprosthetic infection developed in 17 patients. These 17 patients underwent 1-stage implant salvage. Patients were monitored for ≤6 years.


RESULTS
All implants were retained; aesthetic results were satisfactory; and no significant adverse events were recorded after implant salvage.


CONCLUSIONS
One-stage implant salvage for periprosthetic infection has similar outcomes to conventional multistage procedures and may be preferred by patients.


LEVEL OF EVIDENCE
4.


Breast Surgery
Breast augmentation is the most common cosmetic procedure in the United States, with more than 330 000 surgeries performed annually. 1 Concomitant with the increase in breast surgery has been an increase in complications, particularly periprosthetic infections. Significant morbidity and negative aesthetic outcomes can result when periprosthetic infections are treated inadequately. Currently, emergency explantation and administration of antibiotics is the only effective method of infection control for periprosthetic infection following breast augmentation. 2 The expanded space previously occupied by the implant must be void until the infection is eliminated. This period of recovery before potential implant reinsertion may be prolonged and can adversely affect aesthetic outcomes and the psychological well-being of the patient. Patients who elect to undergo cosmetic breast implantation often are psychologically vulnerable, and they 545985A ESXXX10.1177/1090820X14545985Aesthetic Surgery JournalSforza et al

research-article2014
Dr Sforza directs the Elective Internship Program in Plastic Surgery at Dolan Park Hospital in Bromsgrove, United Kingdom, and is an Examiner for the Royal College of Surgeons of Edinburgh. Dr Andjelkov is a plastic surgeon in private practice in Belgrade, Serbia. Mr Husein is a medical student at Leeds Medical School in the United Kingdom. Dr Zaccheddu is a plastic surgeon at Dolan Park Hospital. may experience significant psychological trauma after infection and explantation. One-stage implant salvage-in which the prosthesis is replaced with a new implant during a single surgical procedure-may benefit these patients.
Successful 1-stage salvage of prostheses in the presence of a periprosthetic infection has been reported but is not routine. Salvage procedures generally involve rigorous sequential cleaning, immediate implant replacement, and postoperative antibiotic administration. In this retrospective study, the authors describe their experience during a 6-year period with implant salvage surgery in patients with periprosthetic infections following cosmetic breast enlargement.

Selection of Patients
We performed a retrospective analysis of salvage implant surgeries owing to periprosthetic infections that occurred after cosmetic breast augmentations from January 2008 to December 2013. A total of 3012 patients underwent primary breast augmentation with textured cohesive gel silicone implants (5998 implants inserted). All brands were registered with the Medicines and Healthcare Products Regulatory Agency of the United Kingdom and were CE marked. The majority (76%) of the implants were placed in the subpectoral plane; 24% were placed in the subglandular plane. All operative procedures were performed by 2 experienced surgeons (M.S., R.Z.), and all patients received prophylactic antibiotics for 24 hours.
Of the 3012 patients who underwent breast augmentation, 17 of 5998 (0.28%) implants developed periprosthetic infection requiring surgery. All infections were unilateral. Patients who underwent implant salvage surgery were included in the present study if they showed clinical signs of infection, lacked signs of sepsis (by clinical examination and/or laboratory results), and had an implant exposure time (ie, duration of implant exposure through the wound) of less than 48 hours. Clinical signs of infection included an increase in body temperature and in the volume of the affected breast (with or without pain) and/or collection of purulent fluid at the surgical scar site, leaking into the area of the exposed implant, or around the implant. Signs of sepsis included a body temperature ≥38°C and leukocytosis (ie, white blood cell count >12 × 10 9 /L). 3

Protocol for Implant Salvage
An efficient after-care system is associated with the authors' practice, and an operating room is available 7 days a week. Upon confirmation of infection of the breast pocket, patients were administered antibiotics. Informed consent was obtained for the 1-stage salvage procedure after all risks and potential benefits were explained. All patients were informed that the procedure was experimental and that explantation would be necessary if infection recurred within 4 to 8 weeks.
Within 24 hours after the infection was confirmed, 1-step salvage surgery was performed with the patient under general anesthesia. The implants were exposed in all 17 patients, but no patient was exposed for more than 48 hours. Each surgery was performed by the same surgeon and at the same hospital as the patient's primary augmentation (Figures 1 and  2). The original scar was resected to allow access to the pocket and provide fresh skin borders for posterior closure. After exposure of the breast pocket, wound swabs and any discharged fluids were sent for bacterial culture and sensitivity testing. The implant was removed and discarded. Sequential cleaning then was performed, as follows: (1) The cavity of the capsule was cleansed with 2% chlorhexidine gluconate scrub, and an abdominal swab wet with 0.5% chlorhexidine alcohol was placed in the pocket for 5 minutes; (2) the cavity of the capsule was scrubbed with abdominal swabs drenched in half-strength hydrogen peroxide, and the swabs were left in the pocket for 5 minutes; (3) the capsule cavity was irrigated with approximately 2 L of normal saline and then scrubbed with povidone-iodine. An abdominal swab wet with povidone-iodine then was left in the pocket for 5 minutes. For 1 patient with capsular contracture (Baker 2), radial capsulotomy was performed followed by rigorous hemostasis. After sequential cleaning, a drain was inserted (size 8 vacuum-assisted drainage system; Medinorm Medizintechnik GmbH, Spiesen-Elversberg, Germany), and a new implant was placed in the pocket before closure of the incision in 4 layers with polydioxanone absorbable sutures.
All patients were reimplanted in the original pocket with the same size, brand, and model implant that they received during the primary surgery to maintain consistency with the unaffected breast. Solutions of 1.5 g cefuroxime in 18 mL saline and 80 mg gentamicin (2-mL ampoule) in 40 mL povidone-iodine were injected through the drain. The drain then was clamped for 4 hours. Patients received intravenous antibiotics for 24 hours postoperatively, as follows: 3 doses of 1.5 g cefuroxime and 1 dose of 120 mg gentamicin. The drain was removed within 12 hours following surgery based on the amount of time necessary to remove excess povidone-iodine or debris from the pocket. Patients were discharged from the hospital with a prescription for 500 mg oral ciprofloxacin 3 times a day for up to 10 days. Antibiotics were adjusted based on the antibiogram results and the opinion of the microbiologist. All patients were monitored for 8 weeks until the infection was resolved.

Statistical Analysis
All data were analyzed with SPSS v.19 software (IBM, Armonk, NY). Statistical significance was ascertained by Fischer's exact test and was defined as P < .05.

RESuLtS
The 17 patients included in the study were women (mean age, 31.76 ± 5.22 years; age range, 22-57 years) who presented with fever and with swelling, tenderness, erythema, and pus in the surgical area of the affected breast following primary augmentation. None of the patients had comorbidities or risk factors for infection, such as diabetes, a history of steroid use, or immunosuppression. Smoking was not an exclusion criterion for the salvage procedure, and smokers and nonsmokers were analyzed equally. No patient presented with infection in any areas other than the surgical site. Notably, the same surgical protocol would be performed even if other areas of infection were observed; this also is the protocol for seroma cases in our practice.
Pseudomonas aeruginosa was isolated from 1 patient; methicillin-sensitive Staphylococcus aureus was isolated from 9 patients; methicillin-resistant S aureus was isolated from 2 patients; Staphylococcus epidermidis was isolated from 2 patients; and mixed flora were isolated from 3 patients (Table 1). Laboratory antibiotic sensitivity testing results indicated adequate sensitivity to ciprofloxacin for all specimens.
Secondary implants were retained in all 17 patients (P < .001; Figures 1-3). Recovery and healing times for smokers and nonsmokers were similar. In our practice, we offer aftercare with 3 years of free revisional surgery in case of capsular contracture, implant rupture, or unsatisfactory aesthetic results. Patients were monitored for 3 to 6 years postoperatively in this study. Although we did not assess patient

diScuSSion
Successful salvage of breast implants following periprosthetic infection associated with breast augmentation first was reported in 1965. 4 This procedure was critically revisited in a pioneering report by Planas et al 5 on salvage attempts in cosmetic surgery. Planas et al salvaged 80% of exposed implants from patients with periprosthetic infections. In 2003, Fodor et al 6 reported a 50% salvage success rate with conservative treatment of the implants, even when exposed. These authors avoided sequential cleaning of the pocket, retained the original implant, and attempted to close wounds upon cessation of discharge.
Implant salvage is not unique to breast-related surgery. Results of orthopedic studies involving total hip replacement with debridement in 5 patients with S aureus infection indicated a 100% success rate when the authors applied a salvage technique similar to the 1-step salvage protocol described herein. 7,8 Success rates exceeding 70% have been described for infected penile implant salvage 9-12 and infected prosthetic vascular graft salvage. [13][14][15] High success rates have been described for expander prosthesis salvage in breast surgery, even when associated with radiotherapy in malignant disease. 16 A salvage success rate of 100% was reported in a series of periprosthetic infections following mastectomy reconstructions associated with malignancy; this success rate is impressive because the risk of tissue breakdown is much higher in cases of malignancy. 17 Infection rates for primary breast augmentation can approach 2%. 18,19 Recently, Spear et al [20][21][22] advocated the salvage of infected implants and described a nonvalidated method of patient assessment whereby the surgical approach is determined by the severity of the periprosthetic infection with the goal of improving the salvage success rate. In a 15-year retrospective study, Spear and Seruya 22 reported a 93.9% salvage success rate for patients with mild infections and a 26.3% success rate for patients with severe infections. These authors performed risk stratification to identify the complication stage at which salvage should be attempted. Severe infection generally develops after 48 hours, as evidenced by an increased number of bacterial colonies. Because Spear and Seruya 22 reported that the success rate for salvage in the presence of severe infections is low, we implemented a 48-hour maximum exposure duration for implants to increase our salvage success rate.
Infection severity is vital to salvage success, and every effort should be made to determine the grade of infection. In our opinion, implant exposure time also is important and may influence the severity of untreated and progressive infections. This is exemplified in case reports and series in which implant preservation was unsuccessful despite a seemingly mild infection. 5,21 We suggest that a prolonged implant exposure time allows for greater colonization of the pocket and shelters a subclinical infection. This infection may subsequently be reactivated despite intense cleansing, resulting in salvage failure. Our 100% success rate may be attributable to our adherence to a ≤48hour exposure window. A protocol that accounts for both exposure time and infection severity may further optimize implant salvage; more research is needed to predict salvage success by infection grade. The present study excluded patients with diabetes or undergoing immunosuppression; these variables should be investigated in a future study.
The protocol employed in this study to treat and prevent infection involved the implementation of mechanical and chemical factors. The authors' disinfection protocol included scrubs with 3 chemical agents (chlorhexidine gluconate, hydrogen peroxide, and povidone-iodine) to physically peel away the superficial colonized layers of the capsule and maximize the antimicrobial effect. Various chemical agents were applied to ensure the elimination of a broad spectrum of microorganisms. Chlorhexidine gluconate destroys a wide range of bacteria and yeast species and some types of fungi and viruses. It binds strongly to skin, mucosa, and other tissues and is poorly absorbed into the skin. There is no known contraindication to the application of chlorhexidine gluconate to exposed breast tissue. We consider chlorhexidine gluconate to be safe when placed inside the breast pocket and rinsed after 5 minutes. No allergic or toxic reactions to chlorhexidine gluconate were recorded in our series. Antibiotics also were introduced into the pocket to eliminate retained bacteria and prevent recolonization.
In a recent study published in the Journal of Antimicrobial Chemotherapy, Presterl et al 23 reported that hydrogen peroxide at concentrations of 3% or 5% was the most effective agent for reducing biofilms and eliminating bacteria in cardiac implants. Hydrogen peroxide at a concentration of 3% (v/v) may be applied to biofilms on implants, on tissue surrounding the implant, on the skin surface, or on infected wounds without causing skin irritation or breakdown.
Disinfection with povidone-iodine remains controversial. Breast implant manufacturers typically void the warranty if the implant surface contacts povidone-iodine products (eg, Betadine). In 2007, an Allergan (Santa Barbara, CA) warranty certificate included the statement, "Do not allow the implant to come into contact with povidone-iodine." 24 In 2009, Allergan and Mentor (Santa Barbara, CA) warranty certificates stated, "Do not immerse the implant in Betadine solution. If Betadine is utilized in the pocket, ensure that it is rinsed thoroughly so no residual solution remains in the pocket." 25,26 As of 2011, some Allergan warranty certificates have omitted statements regarding the application of povidone-iodine. 27 The Dreamxcell (Mettmann, Germany) implant warranty states, "Dreamxcell does not recommend rinsing the implant with povidone-iodine solution before inserting into the body." 28 However, these statements are not absolute requirements, and evidence is scarce regarding any damage or decrease in implant integrity after contact with povidone-iodine.
We previously reported a salvage success rate of 100% with our 1-stage salvage technique with no cases of capsular contracture during 18 months of follow-up. 29 We continued to monitor these patients for 3 to 5 years. We report in the present study that 16 patients continued to progress well, and 1 patient developed Baker grade 2 bilateral capsular contracture. During follow-up, this patient was pregnant, gave birth, and breastfed. We consider this patient's capsular contracture to be hormone-related and not caused by the 1-stage salvage performed 3 years previously. Notably, the patient's capsular contracture was bilateral, whereas the salvage was unilateral.
We did not include the case of capsular contracture in the results of our previous study 29 because we were interested in long-term follow-up of patients specifically for capsular contracture. The senior author (M.S.) can confirm that no other cases of capsular contracture have been recorded in the study group. We attribute the lack of capsular contracture among the remaining 16 patients to our triple-agent cleansing protocol, which presumably caused a dramatic reduction in bacterial colonization and biofilm formation.

concLuSionS
The recent increase in prosthetic breast surgeries has precipitated a related increase in cases of periprosthetic infection requiring additional surgery. Conventional 2-stage treatment of an infected implant (ie, implant removal with replacement occurring months later) is associated with morbidity, poor aesthetic outcomes, and underrecognized psychological trauma in a vulnerable group of patients. Patients and clinicians prefer any salvage procedure that reduces the hospital stay, number of operative procedures, and time to normal aesthetic appearance. We believe that 1-stage implant salvage is a valuable, if not superior, alternative to permanent explantation in certain patients. Additional studies are warranted to further validate the utility of 1-stage implant salvage.

disclosures
The authors declared no conflicts of interest with respect to the research, authorship, and publication of this article.