One-stage breast reconstruction using McGhan Style 150 biodimensional expanders: a review of 107 implants with six years experience.

Permanent expanders have revolutionised breast reconstructive surgery, allowing one-stage procedures and the development of increasingly sophisticated implants (textured, anatomically shaped) has played an important role in enhancing the aesthetic outcomes. It is important to evaluate the tolerability of the implant. The aim of this present study was to evaluate the survival curves for McGhan Style 150 permanent expanders, in a consecutive series of breast reconstructions. Complications rates were also examined. Between April 1997 and May 2003, 107 McGhan Style 150 expanders (either full height or short height depending on patients' requirements) were used in 97 consecutive patients for a variety of breast reconstructive procedures. Overall, 46 devices were used for immediate reconstruction, 15 for delayed reconstruction and 46 for implant exchange, respectively. The mean age at implantation was 48 years (min: 26; max: 71). The mean follow-up was 60 months (min: 12; max: 72). Explantation was considered the most objective outcome variable, therefore this parameter was carefully monitored and then analysed using the Kaplan-Meier method of survival analysis. Different curves were compared using the log-rank test. Long term complications were also recorded. Among complications the most frequent finding was Baker 3-4 capsular contracture, occurring in 26% of immediate reconstructions at six years. Explantations increased in an almost linear fashion, with an overall rate of 25%, with a statistically significant difference among immediate reconstruction group and the implant exchange group. The rate of explantations was high, if compared with other series, because the sample included patients undergoing strong adjuvant therapies, particularly in the immediate group (locally advanced disease). The overall rate of explantations and of capsular contracture was found to be significantly lower in the delayed and substitution groups, than the immediate group (p<0.05). In our hands, the McGhan Style 150 anatomically shaped permanent expanders were associated with acceptable results, especially when used as 'permanent prostheses' for second stage procedures.

Trilucent breast implants: five years' experience from an Italian perspective.

In June 2000 the Medical Devices Agency (MDA) issued a Hazard Notice recommending the explantation of Trilucent breast implants (TBP) as a precautionary measure. Following that recommendation, we reviewed our series of 52 patients (71 implants) operated on from 1994 to 1998 to recall and advise those still harboring TBP. We have analyzed all the recorded adverse events in our setting before June 2000 to estimate the adverse reaction frequency and their time relation (review series). We have also recorded the rate of preoperative symptoms and postoperative findings in 23 patients (29 implants) who underwent explantation after the MDA recommendation (explantation series). In addition, some histologic observations have been made. The rates of significant capsular contracture (Baker 3-4) and explantations were estimated using the Kaplan-Meier method of survival analysis, and the rates of wrinkling and palpability were compared at 1 and 5 years of follow-up. Overall, the rate of grade 3-4 capsular contracture was approximately 45% at 6 years of follow-up with no statistically significant difference among the reconstruction and augmentation groups. The analysis of survival curves showed an overall rate of approximately 55% of explantations at 6 years. Preoperatively, capsular contracture and volume modifications were the most frequent findings in the explantation series. Postoperatively, most implants opposed inadequate resistance to the operative stress and ruptured, showing a creamy content. Free oil has never been found in tissue surrounding the periprosthetic capsule. In conclusion, it appears that the TBP-claimed advantages over other available implants seem to be inconsistent and the MDA advice appropriate. The problems related to these implants have had a great impact on public opinion in Europe and have contributed to the implementation of the conformity assessment procedures to be followed for medical devices: on the 4th February 2003 breast implants were in fact reclassified as class 3 products, in order to provide the best guarantee for health protection. The publication of a communication by the European Parliament in November 2001 gives us hope for the future.