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.
Cicchetti
Silvia
S
Department of Plastic and Reconstructive Surgery, University of Genoa, IST, National Cancer Institute Genoa, Largo Rosanna Benzi 10, 16132 Genoa, Italy. silviacic@yahoo.it
Spina
Bruno
B
Nicolò
Guido
G
Santi
Pier Luigi
PL
D000328:Adult; D000368:Aged; D019928:Breast Implantation; D018427:Breast Implants / Q000009:adverse effects; D005260:Female; D006801:Humans; D008875:Middle Aged; D012189:Retrospective Studies