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Trilucent breast implants: five years' experience from an Italian perspective
Silvia Cicchetti1, Bruno Spina, Guido Nicolò
1Department of Plastic and Reconstructive Surgery, University of Genoa, IST, National Cancer Institute Genoa, Largo Rosanna Benzi 10, 16132 Genoa, Italy. silviacic@yahoo.it
Annals of Plastic Surgery
|September 11, 2003
Summary
Trilucent breast implants (TBP) showed high rates of capsular contracture and explantation, with many rupturing during surgery. The Medical Devices Agency
Area of Science:
- Medical device safety
- Plastic and reconstructive surgery
- Biomaterials science
Background:
- The Medical Devices Agency (MDA) issued a hazard notice in June 2000 recommending explantation of Trilucent breast implants (TBP).
- A review of 52 patients (71 implants) operated on between 1994-1998 was conducted to assess adverse events and patient outcomes.
- Histologic observations were also performed.
Purpose of the Study:
- To estimate the frequency and time relation of adverse reactions associated with Trilucent breast implants (TBP) prior to June 2000.
- To record preoperative symptoms and postoperative findings in patients undergoing explantation after the MDA recommendation.
- To evaluate the long-term safety and efficacy of TBP.
Main Methods:
- Survival analysis using the Kaplan-Meier method to estimate rates of capsular contracture (Baker 3-4) and explantation.
- Comparison of wrinkling and palpability rates at 1 and 5 years.
- Analysis of preoperative symptoms and postoperative findings in an explantation series.
- Histologic examination of explanted devices.
Main Results:
- Approximately 45% rate of grade 3-4 capsular contracture at 6 years post-implantation.
- Approximately 55% rate of explantation at 6 years.
- Implants frequently ruptured during surgery, exhibiting creamy content; free oil was not found in surrounding tissues.
- Preoperative findings included capsular contracture and volume changes; postoperative issues involved implant rupture.
Conclusions:
- Trilucent breast implants (TBP) demonstrated significant rates of complications, including capsular contracture and rupture, questioning their claimed advantages.
- The MDA's recommendation for explantation was deemed appropriate based on the observed adverse event rates.
- The issues with TBP contributed to the reclassification of breast implants as class 3 medical devices in 2003, enhancing patient safety regulations.