Clinical Considerations Regarding the Risks and Benefits of Textured Surface Implants and Double Capsule

Sir: The following comments pertain to “Breast Implant Complication Review: Double Capsules and Late Seromas” by Hall-Findlay (Plast Reconstr Surg. 2011;127:56–66). We appreciate the detailed perspective provided, but do wish to consider the clinical significance of double capsules, and particularly the overall risk-to-benefit proposition offered by textured implants. The clinical significance of double capsules and its potential association with late periprosthetic fluid collections (“seromas” lasting longer than 1 year) is unclear because of the following: (1) valid, prospective studies characterizing late periprosthetic fluid collections and epidemiology linking these rare occurrences to double capsules are lacking; and (2) in Hall-Findlay's retrospective review, only three of the 14 double capsule cases presented as “seromas,” whereas the remaining 79 percent were identified coincidentally at unrelated revisions (shape/size, n = 6; contracture, n = 5). Double capsule is a poorly characterized term, and a clear definition is required. Textured devices are designed to facilitate tissue adherence. Therefore, incomplete patches of capsule adherent to a device should not be considered a “double capsule” (Fig. 1). Conversely, capsular adherence in two layers (inner adherent to device, and outer adherent to tissue) should be defined as a double capsule, and may be clinically relevant (Fig. 2). Periprosthetic fluid collections may accumulate in the potential space between these layers and be described as a seroma.Fig. 1.: In Hall-Findlay's review, this example of “early double capsules” shows instead incomplete patchy fibrous adhesion to a textured implant. (From Hall-Findlay EJ. Breast implant complication review: Double capsules and late seromas. Plast Reconstr Surg. 2011;127:56–66.)Fig. 2.: Complete circumferential double capsules. Note both the attachment of the inner capsule on the textured device to the outer capsule on tissue (arrow), and the absence of capsular adherence to the smooth implant patch. (Photograph courtesy of Steven Teitelbaum, M.D.)The cause of double capsules remains unknown but is likely multifactorial—including a foreign body response and/or the following perioperative factors: (1) large implant pockets may limit tissue-device adherence and allow fluid to collect1; (2) subglandular implants may experience greater micromotions and mechanical shear1,2; (3) trauma2; and (4) infection/biofilm.2 In our extensive combined experience, an oversized implant pocket, in a subglandular position, without perisurgical drainage, and without limiting early postoperative activity, may all contribute to suboptimal device-tissue adherence and potentially a double capsule. Few other double capsule reports exist in the literature,2,3 and none report frequency. Manufacturer postapproval reporting rates are very low with Biocell: double capsules, 0.019 percent (two in 10,000; stable over 3 years of complete data from 2006 to 2008); and late periprosthetic fluid collections, 0.12 percent (one in 1000).4 In the world's largest experience with Biocell 410 implants, Hedén has observed a double capsule incidence of approximately 1 percent in over 7000 patients. These rare double capsule occurrences must be weighed against the widespread clinically important benefits of texturing. Implant revisions are most frequently for capsular contracture. A meta-analysis (level Ib evidence) demonstrated that textured shells clearly reduce the risk of contracture for subglandular implants (odds ratio, 0.19; 95 percent confidence interval, 0.07 to 0.52).5 Review of randomized controlled trials (235 patients with 470 implants) found a significantly increased risk of contracture for smooth subglandular implants (relative risk, 7.25; 95 percent confidence interval, 2.42 to 21.69 at 3 years).6 The median time to reoperation has been reported as significantly longer with textured shells.7 Texturing decreases the rate of shaped implant rotation and facilitates implant/soft-tissue interaction or “oneness.”1 In summary, through disrupting longitudinal contraction vectors and fibrous capsular contraction, the clinical benefits of texturing may have a substantial impact on tens of thousands of women with regard to improved aesthetic outcomes and fewer reoperations, whereas double capsules are rare and of uncertain clinical significance. DISCLOSURE Dr. Maxwell, Dr. Brown, and Dr. Heden are consultants to Allergan, Inc. Dr. Oefelein and Dr. Kaplan are employees of Allergan, Inc. G. Patrick Maxwell, M.D. Maxwell Aesthetics Nashville, Tenn. Mitchell H. Brown, M.D. Division of Plastic Surgery Department of Surgery University of Toronto Toronto, Ontario, Canada Michael G. Oefelein, M.D. Hilton M. Kaplan, M.D., Ph.D. Allergan, Inc. Irvine, Calif. Per Hedén, M.D. Akademikliniken Stockholm, Sweden