Assessing Long-Term Outcomes in Breast Implant Illness: The Missing Link? A Systematic Review

 

by Rohrich, Rod J.; Bellamy, Justin L.; Alleyne, Brendan 

 

Plastic and Reconstructive Surgery: April 2022 - Volume 149 - Issue 4 - p 638e-645e

 

The purpose of this special topic article is to explore the current state of outcomes-based literature related to breast implant illness and summarize the key understandings that emerge from the summation of existing studies. While implanted silicone devices are some of the most ubiquitous products in modern medicine, the safety of silicone breast implants has long remained under scientific scrutiny. In the era of social media and with breast implants once again under public scrutiny with the recent connection of texture silicone implants to breast implant–associated anaplastic large-cell lymphoma, the borders between breast implant illness and other implant-related diseases are becoming clouded in the public eye. The surgical management options for breast implant illness range from simple implant explantation alone to complete en bloc capsulectomies, or even secondary exploratory operations for additional capsulectomy in persistently symptomatic patients. In this review of outcomes-based studies related to breast implant illness, the authors found that a subset of patients improves with surgical intervention but limited evidence to inform most current surgical management practices. Further, the nature of this illness renders it difficult to study. A carefully designed, large, prospective, outcomes-based study is still required if an evidence-based and sound treatment approach for this condition is to be established.

 

Fat Grafting before Delayed Prophylactic Mastectomy and Immediate Implant Reconstruction for Patients at High Risk of Complications

 

by Lesniak, David M.; Sarfati, Isabelle; Meredith, Ineke; Millochau, Jenny; Wang, Kuan-Chi; Nos, Claude; Clough, Krishna B. 

 

Plastic and Reconstructive Surgery: January 2022 - Volume 149 - Issue 1 - p 52-56

 

The majority of patients undergoing bilateral prophylactic mastectomy request immediate implant-based breast reconstruction. Some patients, especially those with prior radiotherapy, are at increased risk of early cutaneous complications and implant loss. The authors developed the technique of primary fat grafting before delayed prophylactic mastectomy to minimize early complications for selective high-risk patients. They have completed 21 cases in 14 patients, 10 of whom had previous lumpectomy and radiation treatment for breast cancer. A single session of fat grafting, with a median injection volume of 250 ml (interquartile range, 200 to 300 ml), was performed a median period of 19 weeks (interquartile range, 16 to 28 weeks) before prophylactic mastectomy. All cases were direct-to-implant reconstruction using textured silicone implants. The median implant volume was 410 ml (interquartile range, 318 to 450 ml). A minor early complication developed in 14 percent of cases (three of 21), with no early implant loss. At a median follow-up of 9 months (interquartile range, 5 to 27 months), the authors found no cases of implant loss and an excellent or good aesthetic outcome (score of 5 or 4) in 16 of 21 cases (76 percent). Fat grafting before prophylactic mastectomy is a novel strategy to minimize early complications and avoid implant loss in patients at high risk of postoperative complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, 

The Baker Classification for Capsular Contracture in Breast Implant Surgery Is Unreliable as a Diagnostic Tool

 

The Baker Classification for Capsular Contracture in Breast Implant Surgery Is Unreliable as a Diagnostic Tool

 

by de Bakker, Erik; Rots, Mathijs; Buncamper, Marlon E.; Niessen, Frank B.; Smit, Jan Maerten; Winters, Henri A. H.; Özer, Müjde; de Vet, Henrica C. W.; Mullender, Margriet G.

Plastic and Reconstructive Surgery: November 2020 - Volume 146 - Issue 5 - p 956-962

 

Background:

Breast implants are frequently used in cosmetic and reconstructive breast surgery. Capsular contracture, the most common long-term complication, is usually graded using the Baker classification. Despite its widespread use, the reliability of the Baker classification has never been established. The aim of this study was to determine the interobserver reliability and agreement of the Baker classification.

Methods:

Sixty women who had undergone cosmetic breast augmentation were included. They were examined independently by two plastic surgeons from an observer pool. The Baker score was determined, along with firmness, dislocation, symmetry, and pain using four-point scales. Patients were asked to complete the BREAST-Q postaugmentation module. The interobserver reliability and agreement were calculated for all variables with a quadratic weighted kappa.

Results:

The interobserver reliability of the Baker classification was poor (kappa, 0.55; 95 percent CI, 0.37 to 0.72). Interobserver reliability of the clinical parameters firmness (0.64; 95 percent CI, 0.49 to 0.79), dislocation (0.49; 95 percent CI, 0.26 to 0.73), and symmetry (0.61; 95 percent CI, 0.34 to 0.88) was also poor. Pain scores seemed more reliable (0.72; 95 percent CI, 0.56 to 0.89); however, most patients had no pain. The interobserver agreement for the Baker score was 48 percent; in 43 percent, the observers differed one category; and in 12 percent, the difference was more than one category.

Conclusions:

Interobserver reliability and observer agreement of the Baker classification for capsular contracture were poor. Consensus about how to adequately rate the symptoms of capsular complaints is lacking. A more reliable method of measurement or description is needed, especially for scientific research purposes, to assess the long-term problems associated with breast implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, IV.

Complication Profiles by Mastectomy Indication in Tissue Expander Breast Reconstruction

Complication Profiles by Mastectomy Indication in Tissue Expander Breast Reconstruction

 by Chouairi, Fouad; Gabrick, Kyle S.; Avraham, Tomer; Markov, Nickolay P.; Alperovich, Michael  

Plastic and Reconstructive Surgery: April 2019 - Volume 143 - Issue 4 - p 682e-687e

Background: Two-stage implant breast reconstruction is the most commonly performed breast reconstruction procedure. Limited data exist regarding reconstruction complication rates examined by mastectomy indication.

Methods: Patients who underwent two-stage implant breast reconstruction at Yale New Haven Hospital from 2011 to 2017 were included in the study. Perioperative complications were compared. Chi-square analysis, t tests, and Fisher’s exact tests were used to determine significant associations. A binary logistic regression was used to determine variables with a significant impact on the likelihood of mastectomy flap necrosis.

Results: Between 2011 and 2017, complete perioperative records were available for 141 patients who underwent 226 mastectomies followed by two-stage tissue expander/permanent implant reconstruction. Of the 226 mastectomies, 134 were therapeutic and 92 were prophylactic. On regression analysis, there were no significant differences in demographics, comorbidities, or mastectomy and reconstructive details between the two breast groups except for there being more modified radical mastectomies in therapeutic breasts (p = 0.003). When comparing complications, there was a significantly higher risk of mastectomy flap necrosis in the therapeutic group (p = 0.017). Therapeutic mastectomies had a 9.5 times higher risk of mastectomy flap necrosis than prophylactic mastectomies when adjusted for confounding variables. There were no significant differences in other reconstructive complications between the two groups.

Conclusions: Patients undergoing therapeutic mastectomies have a significantly higher risk of mastectomy flap necrosis than those undergoing prophylactic mastectomies. Although the underlying cause still needs to be determined, differences in technique may be related to mastectomy flap necrosis. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, II.

Breast Implant Mycobacterial Infections: An Epidemiologic Review and Outcome Analysis

Breast Implant Mycobacterial Infections: An Epidemiologic Review and Outcome Analysis

Authors:  Al-Halabi, Becher; Viezel-Mathieu, Alex; Shulman, Zachary; Behr, Marcel A.; Fouda Neel, Omar  

Plastic and Reconstructive Surgery:  November 2018 - Volume 142 - Issue 5 

Background: Epidemiologic evidence of periprosthetic mycobacterial infections is limited. The recent boom in cosmetic surgery tourism has been associated with a rise of surgical-site infections in returning patients. This review aims to explore available data, examine trends of documented periprosthetic mycobacterial infections, and analyze outcomes of management techniques. Methods: A search in the Biosis, Embase, LILACS, MEDLINE, and Web of Science databases from inception until December of 2017 for “Breast Implants” and “Mycobacterial Infections” and equivalents was performed. Data were pooled after two screening rounds following full-text retrieval and cross-referencing.

Results: Forty-one reports describing 171 female patients who had breast prosthesis–related mycobacterial infections were identified. Bibliometric case-based analysis revealed a rise of periprosthetic mycobacterial infections in developing countries since the start of the millennium. The mean patient’s age was 37.9 years and the majority of patients had undergone bilateral breast augmentation. Most patients presented with breast pain or tenderness, after an average incubation period of 9 months. Mycobacterium fortuitum was isolated from 90 cases (52.6 percent). Immediate explantation with or without delayed reimplantation was the most commonly used surgical strategy, complemented by combination antimicrobial therapy for an average of 4.6 months. The mean follow-up time was 39.7 months, during which recurrence was observed in 21 of 171 patients (12.3 percent).

Conclusions: The emergence of periprosthetic mycobacterial infections in relation to cosmetic medical tourism alerts clinicians to the importance of educating the public about the associated risks. In addition, this study identifies risk factors associated with recurrence of periprosthetic mycobacterial infections.

The Functional Influence of Breast Implant Outer Shell Morphology on Bacterial Attachment and Growth

The Functional Influence of Breast Implant Outer Shell Morphology on Bacterial Attachment and Growth

by Jones, Phoebe; Mempin, Maria; Hu, Honghua; Chowdhury, Durdana; Foley, Matthew; Cooter, Rodney; Adams, William P. Jr; Vickery, Karen; Deva, Anand K.  

Plastic and Reconstructive Surgery: October 2018 - Volume 142 - Issue 4 - p 837–849

Background: The introduction of texture to the outer shell of breast implants was aimed at increasing tissue incorporation and reducing capsular contracture. It has also been shown that textured surfaces promote a higher growth of bacteria and are linked to the development of breast implant–associated anaplastic large cell lymphoma.

Methods: The authors aimed to measure the surface area and surface roughness of 11 available implants. In addition, the authors aimed to subject these implant shells to an in vitro bacterial attachment assay with four bacterial pathogens (Staphylococcus epidermidis, S. aureus, Pseudomonas aeruginosa, and Ralstonia pickettii) and study the relationship among surface area, surface roughness, and bacterial growth. Results: Surface area measurement showed grouping of implants into high, intermediate, low, and minimal. Surface roughness showed a correlation with surface area. The in vitro assay showed a significant linear relationship between surface area and bacterial attachment/growth. The high surface area/roughness implant texture grew significantly more bacteria at 24 hours, whereas the minimal surface area/roughness implant textures grew significantly fewer bacteria of all types at 24 hours. For implants with intermediate and low surface areas, some species differences were observed, indicating possible affinity of specific bacterial species to surface morphology.

 Conclusions: Implant shells should be reclassified using surface area/roughness into four categories (high, intermediate, low, and minimal). This classification is superior to the use of descriptive terms such as macrotexture, microtexture, and nanotexture, which are not well correlated with objective measurement and/or functional outcomes.

22 Cases of Breast Implant–Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health

22 Cases of Breast Implant–Associated ALCL: Awareness and Outcome Tracking from the Italian Ministry of Health

Campanale, A et al 

Plastic and Reconstructive Surgery: January 2018 - Volume 141 - Issue 1 - p 11e–19e

Background: To date, 359 cases of anaplastic large cell lymphoma (ALCL) in women with breast implants (breast implant–associated ALCL [BIA-ALCL]) worldwide have been reported among more than 10 million patients who have received implants, but health care authorities suspect this is a possible underestimation, and the limited number of cases makes it difficult to clarify its cause. The General Directorate of Medical Devices and Pharmaceutical Services of the Italian Ministry of Health has examined and studied the Italian BIA-ALCL cases. 
Methods: An official document has been diffused to all medical associations, aiming at encouraging all physicians to notify each BIA-ALCL case. A retrospective study has been performed on the notified BIA-ALCL cases collected in the database named Dispovigilance. Results: Research on Dispovigilance returns a list of 22 BIA-ALCL cases. The mean patient age was 49.6 years (range, 30 to 71 years). The average time to the onset of the symptoms was 6.8 years (range, 1 to 22 years). The average time to diagnosis was 7.8 years (range, 4 to 22 years). The estimated incidence of the Italian BIA-ALCL cases related to 2015 is 2.8 per 100,000 patients. Conclusions: The pathogenesis of BIA-ALCL remains unknown. The establishment of a national breast implant registry is needed to better understand some aspects of this disease. Future genetic studies on the population affected could clarify why only some patients with implants develop this disease.