title: Textured saline-filled breast implants for augmentation mammaplasty: does overfilling prevent deflation? A long-term follow-up.
abstract: BACKGROUND
  Augmentation mammaplasty is the second most commonly performed aesthetic operation. Since the moratorium on gel-filled devices in 1992, saline-filled devices have become the prosthesis of choice in the United States. Although inflatable breast implants have been available since 1965, high rates of complete implant deflation have been reported. In this retrospective study, the authors highlight the effect of filling volume on the incidence of implant deflation, other implant-related trade-offs, and implant survival.
  
  
  METHODS
  Forty-nine women who had undergone aesthetic augmentation mammaplasty were followed up for up to 139 months. Twelve implants were underfilled (group 1), 47 devices were filled within the recommended volume (group 2), and 37 implants were overfilled beyond the manufacturer's maximum recommended volume (group 3). All the implants used were of the same type and from the same manufacturer (Siltex by Mentor, 2600). Through an inframammary approach, subpectoral placement of the device was used exclusively.
  
  
  RESULTS
  Nineteen women experienced complete deflation of their implants, with an overall implant complete deflation rate of 19.79 percent. This complication occurred in 16.6 percent of group 1 patients, 21.2 percent of group 2, and 18.9 percent of group 3. Skin wrinkling and rippling were encountered in 50 percent of group 1, 29.78 percent of group 2, and 43.2 percent of group 3, with an overall incidence of 37.5 percent. In this series, the authors could not find a protective effect of overfilling on complete deflation (p = 0.925) nor on the avoidance of rippling and wrinkling (p = 0.285). Moreover, overfilling by more than 25 ml beyond the maximum recommended dose showed no statistical significance for the frequency of complete deflation (p = 0.982) or for the incidence of wrinkling and rippling (p = 0.828). However, Kaplan-Meier survival analysis revealed that overfilling the implants prolonged their longevity and had a statistically significant effect on the implants' 10-year survival rate. Of the 49 women, 34 (69.3 percent) needed a secondary surgical procedure, mainly for complete deflation (38.7 percent) and skin wrinkling/rippling (20.4 percent). At the end of the current study, eight of 49 women, representing 15 implants, retained their original implants for more than 120 months.
  
  
  CONCLUSIONS
  Use of Mentor 2600 prostheses for aesthetic breast augmentation led to a very high incidence of complete deflation and skin wrinkling and a high reoperation rate. Filling the implants within the recommended range or overfilling them increased device longevity and had a statistically significant effect on the implants' 10-year survival rate.
authors.affiliation: Department of Plastic Surgery, C.H.U. Brugmann, Brussels 1020, Belgium.
authors.forename: Shareef
authors.initials: S
authors.lastname: Al-Sabounchi
authors.forename: Albert M G
authors.initials: AM
authors.lastname: De Mey
authors.forename: Helga
authors.initials: H
authors.lastname: Eder
mesh_terms: D000328:Adult; D019928:Breast Implantation / Q000009:adverse effects / Q000379:methods*; D018427:Breast Implants; D016009:Chi-Square Distribution; D003286:Contracture / Q000453:epidemiology; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D011183:Postoperative Complications / Q000517:prevention & control; D011474:Prosthesis Design; D012086:Reoperation; D012189:Retrospective Studies; D012965:Sodium Chloride
chemical_list: D012965:Sodium Chloride