Multiple authors have described the incidence of double capsule and late seroma in the use of textured implants.46,47 Late seroma is arbitrarily defined as occurring greater than 1 year after implantation. Clinical implications of this phenomenon include breast swelling, infection, implant malposition and rotation, and subsequent need for reoperation.48 These reviews suggest the potential effect of aggressive texturing as a primary culprit in this phenomenon. Hall-Findlay49 suggests that a process of friction between the aggressively textured implant and the surrounding tissue may result in the chronic production of fluid; thus, the rates of seroma may be lower in less aggressively textured devices. The 10-year data from the Allergan 410 Study shows a 1.6 percent rate of seroma formation.25 The 6-year data from the Mentor CPG Study shows a seroma rate less than 1 percent.50 Seroma formation in the Sientra 9-year data for true textured devices was 1.2 percent in all primary augmentation devices. Approximately half of these implants were “true textured” devices; the rest were smooth. Derby and Codner’s30 review of textured implant core data attempted to show differences between manufacturers but study design “limited the extent of seroma results reported.” Seroma rates in this study for shaped implants only was 0.2 percent (Fig. 11).
Most concerning in the past two decades is the incidence of breast implant–associated anaplastic large-cell lymphoma (ALCL).51 This entity was first diagnosed and associated with breast implants in 1997, and is almost only associated with a history of textured implants and/or tissue expanders. The most common presentation of these patients is late seroma, with some patients presenting with mass, tumor erosion, or lymph node metastasis. A recent review by Brody52 reviewed the world literature on this entity. Key points include the following: (1) 173 cases were documented, (2) no cases were found in patients with documented smooth devices only (although this remains controversial, as the data in many cases are incomplete), (3) there may be an associated genetic predisposition as suggested for cutaneous T-cell lymphoma, and (4) the cause is likely multifactorial.
Recent research by Deva et al. showed bacterial biofilm and contamination in breast implant–associated ALCL and nontumor (contracture) implant capsules. The capsules from patients with tumor had significant presence of Gram-negative bacteria (Ralstonia species) compared to nontumor capsules (Staphylococcus species). In his discussion, Adams53 explains that these data may support the bacterial induction model, as there are also other types of implant-associated lymphomas. In addition, there is also “a precedent for bacteria-induced lymphoma—specifically a gastric lymphoma associated with Helicobacter pylori (a Gram Negative bacterium similar to Ralstonia and Pseudomonas).” Growing evidence is beginning to support a multifactorial cause, including the factors indicated above: bacterial component, genetic predisposition,54 and the suggestion that implants with a macro texture surface may more readily trigger this rare disease. As the bacterial component is better understood and characterized, there may be a potential preventative role for certain antibiotics. Because of this potential inflammatory pathway, and prevention of capsular contracture in general, Adams55 recommends a 14-step plan to minimize pocket contamination.
Although this entity is rare, the burden of proof and treatment remains with the surgeon for early recognition and proper diagnosis, along with appropriate patient education. Most patients present with an enlarged breast and delayed seroma. The key diagnostic maneuver to rule out ALCL in the late seroma is aspiration of the fluid and examination for the presence or absence of the CD30 marker. The American Society of Plastic Surgeons has created a position statement on the appropriate implant specimen and pathology procedures.56 In addition to U.S. Food and Drug Administration manufacturer-mandated labeling, the American Society of Plastic Surgeons has also added example breast implant–associated ALCL language to downloadable informed consent documents. There has been a significant discussion regarding the inclusion of breast implant–associated ALCL in the standard informed consent process. Clemons et al.57 recently discussed the merits of this.
Finally, the American Society of Plastic Surgeons in collaboration with the U.S. Food and Drug Administration has created the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology Registry. The combination of adequate informed consent, appropriate patient education, proper diagnosis and treatment guidelines, and a prospective registry to guide plastic surgeons’ future decisions should allow a more accurate understanding of this disease entity.
The science of breast augmentation has changed dramatically over the past 5 years. Lista and Ahmad60 noted the lack of systematic processes regarding manufacturer and device data, technique, and decision-making. The introduction of a new generation of textured, shaped, and more cohesive silicone gel implants to the U.S. market has brought not only new devices, but long-term safety data, and more detailed technique approaches to augmentation mammaplasty. In addition, the more accurate awareness of complication rates, breast implant–associated ALCL incidence, and technique options demand a more thorough approach to patient education, surgical planning, and informed consent. Although in its pilot stage, the National Breast Implant Registry should provide additional resources for surgeons to glean best practices and large-scale patient outcome data.
Plastic surgeons should take the opportunity to review these approaches from multiple different authors, and formulate an individual evidence-based approach to breast augmentation. Each surgeon will need to evaluate their own clinical experience and approach to best use these new devices and techniques. Proper awareness and use of the data presented should possibly translate into both improved outcomes and better patient safety and satisfaction.
This article has given the reader an opportunity to review current key components of breast augmentation with implants. Surgeons should carefully review the references in both the article and the CME questions to further refine their knowledge and skill. As in all aspects of our specialty, the blending of art and science serves to advance the delivery of the best results possible to our patients.
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