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

Collis, Nicholas B.Sc., F.R.C.S.(Ed.); Coleman, David M.S., F.R.C.S.(Plast.); Foo, Ivan T. H. F.R.C.S.(Plast.); Sharpe, David T. O.B.E., M.A., F.R.C.S.

Plastic and Reconstructive Surgery: September 2000 - Volume 106 - Issue 4 - p 786-791

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 group, 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 polyurethane-coated 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.

West Yorkshire, England

From the Department of Plastic Surgery at Bradford Royal Infirmary and the Plastic Surgery and Burns Research Unit at the University of Bradford.

Received for publication August 9, 1999;

revised December 9, 1999.

Nicholas Collis, B.Sc., F.R.C.S.(Ed.) 4 Reedling Drive Morley, Leeds West Yorkshire, England United Kingdom LS27 8GQ

Presented at the 12th Congress of the International Confederation for Plastic, Reconstructive and Aesthetic Surgery in San Francisco, California, in July of 1999.

©2000American Society of Plastic Surgeons