Current status of breast implant survival properties and the management of the woman with silicone gel breast implants

Abstract

The survival properties of silicone gel breast implants are dependent on their vintage (year of manufacture), duration in situ and manufacturer. A total of 527 gel implants have been explanted and analyzed in the author's laboratories. Of the 28 first-generation implants (1963 to 1972), 27 (96.4%) remained intact after 14 to 28 years in situ (mean 20.8 years). Of the 216 second-generation implants (1973 to mid-1980s) that were explanted from 1992 to 1998, 158 (73%) had disrupted. Kaplan-Meier survival curves demonstrated significantly different survival properties among second-generation manufacturers. Surgitek implants were by far the least durable. After 14 years, all second-generation Surgitek implants had disrupted. By contrast, after 20 years, about half of the Dow Corning and Heyer-Schulte implants remained intact. Among third-generation implants (mid-1980s to 1992), 43 of 46 (93.4%) remained intact after a mean of 6.3 years (range three to 12 years). The three disruptions were Surgitek implants. Implants from other manufacturers remained intact. However, the disruption frequencies of third-generation implants have yet to be measured over the relevant periods of time. Survival patterns appeared to be related to the thickness of the elastomeric shell of the three generations of implants. Mechanical strength analyses of the elastomeric shells of explants have exhibited little or no large scale material degradation, even after as long as 28 years in situ. The mechanism of implant disruption likely involves the 'fold flaw' theory, whereby an internal abrasion can develop over time at the site of a fold in the implant wall. Diagnosis of disruption is difficult. Mammography is helpful only if there has been extravasation of silicone gel into breast tissue. Extravasation was observed in only 4.2% of second-generation implants removed from 1992 to 1998. It was not seen with first-or third-generation implants. Ultrasound analyses are not generally helpful to predict disruption because they are very operator dependent and because capsular contracture causes folds in the implant wall, which result in false positives. Magnetic resonance imaging is the most accurate imaging modality to detect implant disruption. However, this technology is not indicated for monitoring implant status because it is too costly and time consuming, and because it has significant limitations, particularly with first-generation and textured implants. Careful explantation and direct visual examination are the standards for diagnosing gel implant disruption. Many implant disruptions are likely 'silent', with no specific symptoms or clinical findings. After disruption, none of the following are elevated above the levels seen in control women without implant exposure: serum autoantibodies, blood and serum silicon, and the incidence of breast cancer, autoimmune disease or any other medical disease. There is no evidence to support the existence of any 'novel' or 'atypical' syndrome associated with gel implants. Women over 30 years of age with breast...

An Ordinary Ruler and the Limberg Flap

“…Elicon synthetic fat was promoted and sold by Japan Medical Plastics Center, also known as Koken Kogyo Company, Ltd. 9, 10 Elicon product literature indicates that distribution extended overseas. 16,17 There is no doubt that silicone gel-filled breast implants can rupture. [11][12][13][14] At least one device, the Même-ME, was manufactured in the 1980s without a true shell.…”

The evolution of breast implants

“…There have been three main generations of silicone gel breast implants (Figure 4, top left) and a number of lesser variations (22)(23)(24)(25)(26)(27)(28). First-generation implants were made from approximately 1963 to 1972.…”

“…Thirdgeneration implants also had a 'barrier layer' to reduce the diffusion of low molecular weight (4000 to 24,000 Da) silicone oil, which was thought to contribute to capsular contracture. The introduction of third-generation implants was geographically dependent (26) II) implants had a 0.010 mm barrier coat of fluorosilicone on the interior surface of the shell. The product information sheets with these implants stated that they had a "bleed of 20.8 mg at 12 months".…”

“…Recent studies have indicated that, with the exception of Surgitek implants, third-generation implants have proved to be much more durable than second-generation implants (26,27). However, the effectiveness of the barrier layer to restrict silicone bleed remains unproved.…”

Die Magnetresonanztomographie in der Diagnostik von Brustimplantaten: Eine Übersicht

“…Die Haltbarkeit von Brustimplantaten hängt signifikant von der Implantationsdauer, der Implantatgeneration und vom Prothesenhersteller ab [5] . Implantatrupturen können durch die klinische Untersuchung der Brust lediglich mit einer Sensitivität von 30% bei einer Spezifität von 80% diagnostiziert werden [6] .…”