Ten-Year Review of a Prospective Randomized Controlled Trial of Textured versus Smooth Subglandular Silicone Gel Breast Implants

Nicholas Collis, David Coleman, Ivan T. H. Foo, David T. Sharpe
2000 Plastic and Reconstructive Surgery  
Although textured silicone breast implants have been shown to reduce the incidence of capsular contracture, there is little evidence if this effect is maintained in the long term. It has been 10 years since the double-blind randomized trial in which 53 patients received either Mentor smooth (26) or textured silicone gel implants (27). Of the 14 patients who were not known to have developed a contracture in the smooth group, 11 were reviewed. Three had bilateral contractures. In the textured
more » ... p, 18 of the 24 patients not known to have contractures were reviewed. None had developed contractures. At 10 years, the incidence of capsular contracture was 65 percent of patients with smooth implants (an increase of 6 percent on the 3-year results) and 11 percent for the textured implant patients (no change on the 3-year results). A database containing the details of 1100 patients reinforces these results by examining the differences in contracture rates of textured, smooth, and polyurethanecoated implants. The effect of submuscular placement on reducing contracture rates regardless of texturing is discussed, as is the apparent increase in capsular contracture in patients who smoke. (Plast. Reconstr. Surg. 106: 786, 2000.) Regardless of the debate concerning the safety of silicone and long-term integrity of silicone breast implants, capsular contracture remains the main drawback to the use of these devices. Submuscular placement is a wellestablished method of reducing the contracture rate, a practice commonplace in the United States, where saline-filled implants have been used since the moratorium on silicone gel-filled implants in 1991. 1-3 The introduction of implant surface texturing in the late 1980s greatly reduced the contracture rate around subglandular implants. 4 -6 The causes of capsular contracture and the mechanism of action of texturing in reducing its incidence are still not clear. Although the majority of contractures occur in the short term, allowing short follow-up prospective studies to demonstrate the effect of surface texturing, no studies have shown if this effect is maintained in the long term. We therefore present the 10-year follow-up results of a prospective, randomized, doubleblind, controlled trial of textured versus smooth subglandular silicone gel breast implants. The 1-year and 3-year review results have previously been reported. 5,6 A detailed database provided more evidence for the effect of implant texturing, the development of capsular contracture in other smooth and polyurethane foam-coated implants, and the effect of subpectoral implant placement in reducing capsular contracture rates. PATIENTS AND METHODS In 1989, 53 patients for subglandular cosmetic breast augmentation were randomized (double blind) to receive either bilateral smooth or textured silicone gel breast implants (Mentor Medical Systems). Trial protocols have previously been published. The patients were invited by letter to attend a special review clinic. They were rewarded with a small gratuity of £10 for their cooperation. The senior author, unaware of the im-From the Department of Plastic Surgery at Bradford Royal Infirmary and the Plastic Surgery and Burns Research Unit at the University of Bradford.
doi:10.1097/00006534-200009040-00005 pmid:11007389 fatcat:r6w3v2t3m5dhzmiuyfekmngzre