PATIENTS AND METHODS TOP

Database TOP

Data from patients undergoing breast augmentation from 1997 to 2004 were prospectively recorded in a database. These data included dates of surgery, incision location, pocket location, type of breast pocket irrigation, implant type, implant filler material, implant texture, implant shape, capsule grade, secondary operations, preoperative and postoperative measurements, and complications. The database was assessed to determine the incidence of capsular contracture and possible contributing factors.

Antibiotic Irrigation TOP

The antibiotic irrigation regimen was based on our previous in vitro studies.14,15 Before the U.S.Food and Drug Administration decree (in 2000), the irrigation solution consisted of 50 ml of povidone-iodine, 1 g of cefazolin, 80 mg of gentamicin, and 500 ml of normal saline. After the year 2000, the solution consisted of 50,000 U of bacitracin, 1 g of cefazolin, 80 mg of gentamicin, and 500 ml of normal saline.

Surgical Technique and Postoperative Care TOP

Preoperative intravenous antibiotics were administered to all patients (cefazolin or vancomicin/gentamicin for penicillin-allergic patients).

Implant size and type and incisional approach were chosen based on individual patient breast dimensional analysis,17 soft-tissue characteristics, and patient preferences. Talc-free gloves were used at all times during the procedures. Pockets were developed precisely under direct vision with no blunt dissection, with particular attention paid to hemostasis, as described by Tebbetts.18 Pockets were irrigated with 120 to 150 ml of normal saline followed by 120 ml of the triple antibiotic solution without active evacuation of the irrigation. The skin surrounding the incisions was cleansed with the triple antibiotic solution. Prostheses (saline or silicone gel) were kept in their containers and bathed in the triple antibiotic solution during pocket dissection. A new pair of talc-free gloves was donned before implant insertion and preparation. Implants were inserted with minimal skin contact; insertion sleeves were not used. Filling of the saline implants was performed with sterile injectable saline via a closed system. Subsequent digital implant manipulation or skin/parenchymal redraping maneuvers were performed after the surgeon's gloved fingers were dipped in the triple antibiotic solution. Incisions were closed with interrupted or running 3-0 Vicryl or Prolene in the superficial fascia. Skin was closed with deep subdermal sutures, followed by a subcuticular closure. Steri-Strips (3M, St. Paul, Minn.) were placed and maintained for 6 weeks.

Antibiotics were continued for 5 days postoperatively. All patients wore a well-fitted surgical brassiere, or athletic brassiere, for 6 weeks. Pain control was accomplished with rofecoxib or ibuprofen, and hydrocodone/acetaminophen if needed. Implant displacement exercises were prescribed only for those patients in whom smooth round implants were placed. The exercises involved medial and superior displacement of the implant 10 times, three times per day for 1 month and once daily thereafter.

Postoperative Evaluation TOP

Patients were evaluated postoperatively at 5 days, 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, and yearly thereafter. Examinations were performed by two individual health providers. Any patient with grading discrepancies between the examiners was re-assessed by both providers, and a final determination of grading was made jointly. The degree of capsular contracture was recorded according to a simplified Baker classification. Baker I/II was characterized by a soft breast with no distortion of breast shape. Baker III/IV was characterized by a firm breast and/or obvious distortion of the breast on visual inspection, with or without pain.

Cost Analysis TOP

The charges for the components of the triple antibiotic solution at our institution were obtained from Pharmacy Services (Zale Lipshy University Hospital, Dallas, Texas and other community surgical facilities. Operating room, anesthesia, and surgeon fees were also obtained for patients undergoing bilateral implant exchange procedures. A comparison was performed of the potential cost differences in breast prosthesis placement with and without universal application of the antibacterial irrigation protocol.

RESULTS TOP

A total of 335 patients underwent procedures involving placement of a breast prosthesis. Two hundred forty-eight patients underwent breast augmentation. Twenty-four patients had an implant placed during augmentation-mastopexy procedures. The remaining 63 patients had an implant placed as part of the reconstruction after ablative surgery for breast cancer. Patients with less than 6 months of postoperative follow-up were excluded, as were 14 patients who were lost to follow-up, resulting in 165 augmentation patients, 22 augmentation-mastopexy patients, and 63 reconstruction patients for full evaluation. Of the 14 patients not seen for follow-up, 12 were contacted by telephone, and none of these patients complained of firm breasts (this is for verification only; this group was not included in the analysis).

Mean patient age was 35 years (range, 18 to 63 years) in the augmentation group; 37.5 years (range, 25 to 48 years) in the augmentation-mastopexy group, and 52.2 years (range, 34 to 86 years) in the reconstruction group. The mean follow-up was 14 months (range, 6 to 75 months). The demographics of implant type and pocket plane are reported in Table 1.

The rate of grade III/IV capsular contracture (Table 2) in our study groups was 1.8 percent (three of 172) for patients undergoing primary breast augmentation. Patients undergoing augmentation-mastopexy had a grade III/IV contracture rate of 0 percent. Breast reconstruction patients had a 9.5 percent (six of 57) rate of grade III/IV contracture.

The overall reoperation rates (all causes) were 2.8 percent for augmentation, 16 percent for augmentation-mastopexy, and 10.5 percent for reconstruction (Tables 3 and 4). No augmentation patient developed an infection. One patient each in both the augmentation-mastopexy and reconstruction subgroups developed an infection.

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