Outcomes of Implant Removal and Capsulectomy for Breast Implant Illness in 248 Patients

Jacob Y. Katsnelson, MD; Joseph R. Spaniol, MD; Joshua C. Buinewicz, BA; Frederick V. Ramsey, PhD; Brian R. Buinewicz, MD, FACS

Disclosures

Plast Reconstr Surg Glob Open. 2021;9(9):e3813 

In This Article

Discussion

Brief History of the BII Controversy

The association of breast implants with autoimmune or systemic symptoms is an ongoing, heavily debated topic. Despite early reports of patients with silicone implants developing an immunoadjuvant disease,[21–23] large retrospective studies comparing incidence of autoimmune diseases in women with silicone implants found no association, a finding confirmed by a special committee of the Institute of Medicine in 1999.[19,24–27] This ultimately resulted in lifting the FDA moratorium on silicone implants but has by no means put an end to the controversy surrounding implant-related systemic illness. In recent years, an increasingly large number of women with prominent social media presence are seeking implant removal for a constellation of nonspecific systemic symptoms referred to as BII. A recent review by Magnusson et al[2] suggests that efforts at scientific investigation of an underlying pathophysiology for these symptoms have unfortunately been hampered by misrepresentation in the media and an excessive focus on litigation. The pathogenesis of an immunoadjuvant disease process associated with breast implants has been contested in the literature for decades, with several rheumatology studies stipulating a direct effect of silicone in biochemically altering metabolic or cellular processes,[13,22,28,29] whereas others argue that the constellation of somatic symptoms ascribed to implants may be the result of disrupted pain processing pathways leading to psychological distress in a manner similar to disorders like fibromyalgia.[5,30] The relation of either these hypotheses to BII remains unclear at the present time; however, an important question to address is whether implant removal and excision of the associated capsule as many BII patients specifically request is associated with consistent symptom improvement and postoperative satisfaction. To this end, we sought to characterize the presenting symptoms, demographics, outcomes, and implant and capsular findings of a large cohort of BII patients who presented to the senior author and ultimately elected to undergo implant removal with total capsulectomy.

Presenting Symptoms, Postoperative Outcomes, and Patient Satisfaction

In our cohort of patients, we found that preoperatively the most common presenting symptoms were nonspecific somatic complaints such as generalized pain (163 patients, 67%) and fatigue (133 patients, 55%). This characterizes the difficulty of defining BII as an entity, as complaints are frequently nonspecific and highly subjective in nature, a theme which is shared with reports of immunoadjuvant disease related to silicone implants in the past. We found that in 46 patients who had postoperative follow-up addressing specific symptoms, 44 patients (96%) reported overall improvement. Previous explantation studies have noted substantial symptomatic improvement in patients who did not meet laboratory or diagnostic criteria for known autoimmune disorders, such as the study by De Boer et al[30] which reviewed 23 published case series and reports from 1960 to 2016 and found that nearly 75% of patients reported symptomatic improvement after removal of their silicone implants. Rohrich et al[31] noted that a higher number of musculoskeletal complaints were associated with higher likelihood of improvement in 38 patients with silicone implants who underwent explantation. In the largest retrospective study of explantation in BII patients to date, Wee et al[32] found sustained improvement across 11 symptom domains, which encompassed cognitive, musculoskeletal, and systemic symptoms in 752 patients which was maintained after 30 postoperative days. Interestingly, the authors of this recent study found similar symptom improvement with removal of both silicone and saline implants, and did not observe a difference in patient self-reported outcomes between patients with textured or smooth implants.[32] One of the difficulties in monitoring symptom improvement in BII patients is the duration of follow-up, as many patients are frequently self-referred over a potentially large geographic area and have limited follow-up with their surgeon unless postoperative complications arise. Therefore, it is difficult to address the frequency of symptom recurrence or the success of implant removal in the long term, and previous studies of BII have largely been limited to studying outcomes in the first 6 months.[32,33] In two older explantation studies for patients who complained of systemic symptoms, an initial period of symptom improvement was followed by recurrence when longer duration follow-up was available. Slavin and Goldwyn[34] found that in eight patients who underwent implant removal with systemic complaints, only one of eight patients had sustained improvement after 2.5 years of follow-up. The study was notably limited by the relatively small number of patients with symptoms that fit the pattern of BII, with the majority of patients requesting explantation either from fear of harmful consequences or aesthetic reasons. Godfrey and Godfrey[20] found that in 37 women who underwent explantation followed by autologous breast reconstruction, although 33 had initial improvement 1 month postoperatively, 21 patients had relapse of symptoms by 6 months, and only seven patients reported improvement by 12-month follow-up. Although these prior explantation studies included a subset of women with ostensibly systemic symptoms, evaluation of outcomes was limited by including patients who underwent implant removal due to local symptoms related to contracture, anxiety about implants due to the silicone controversy of the 1990s, or explantation for older generation implants that had a higher rate of rupture and leakage.[20,31,35–38] Additionally, previous studies largely focused on patients with silicone implants in light of the FDA moratorium, whereas the majority (59.8%) of patients in our study had saline implants.

We observed a relatively low complication rate in our practice of implant removal and capsulectomy, with six of 248 (2.4%) patients having a major complication defined as pneumothorax, hematoma requiring evacuation, or DVT, and eight of 248 (4.4%) patients having a minor complication defined as seroma, liquefied hematoma, or wound infection. Other than the singular complication of pneumothorax, it is difficult to ascribe any particular complication to addition of capsulectomy to the procedure. Though the addition of capsulectomy is controversial for asymptomatic patients undergoing removal of textured implants for future concern of BII or BIA-ALCL,[15] a large number of BII patients including our cohort also have a high rate of capsular contracture, and addition of capsulectomy may lead to a more substantial symptom improvement of local musculoskeletal symptoms.[32] A prior small retrospective controlled study by Kappel and Pruijn[39] found a more pronounced improvement in systemic symptoms when capsulectomy was added to the implant removal procedure.

Inflammation on Capsular Histology

We found that acute or chronic inflammation was present in 111 (23%) of capsules on permanent pathology, and there was a significant association with silicone and textured implants. Chronic inflammation in the form of calcification surrounding implants has been found to correlate with implant shell thickness, duration after placement, and integrity of the shell in prior studies, and although more frequently associated with older generation silicone implants, has been associated with the elastomer shell of saline implants as well.[40–42] Additionally, small amounts of silicone in the capsule outside an otherwise intact implant shell have been found to induce chronic inflammation by uptake into macrophages, subsequently triggering cytokine production and fibroblast activity.[43,44] Though we found evidence of this "silicone bleed" phenomenon in five patients with unruptured implants, the clinical relation to BII is currently not understood, as only a small subset of patients in our study demonstrated capsular inflammation on histology or findings of silicone material. The pathogenesis of BII remains largely hypothetical, as no consistent rheumatologic, histologic, or microbiological finding has substantiated a clear underlying pathophysiology for the condition. In light of some promising recent studies such as that by Lee et al,[33] we speculate that textured implants may be associated with more inflammation due to increased propensity for biofilm formation, which may be difficult to detect by routine bacterial cultures. Moreover, Wee et al[32] found that patients with capsular contracture had a significantly greater self-reported improvement after explantation. Though this could partially attest to the mechanical nature of some symptoms such as chest wall restriction, the association with improvement in more nebulous symptoms such as fatigue and cognitive problems could also suggest a shared inflammatory pathogenesis between capsular contractures and BII.

Culture Results

Fourteen patients in our cohort had positive culture results, including eight patients with positive cultures of the right breast pocket and nine with positive cultures of the left breast pocket (3.69%). The most common organisms were strains of Staphlyococcus (47%), which is consistent with cultures of prior studies of periprosthetic implant colonization such as the study by Peters et al,[45] which evaluated the implants and capsules of 100 women who had silicone implants removed between 1992 and 1995. Their group found 42% of the capsules were colonized with bacteria and 25% were heavily calcified suggesting chronic inflammation.[45] Though the clinical relevance of these positive cultures to BII is currently unknown, Lee et al[33] recently compared microbiological data between 50 patients undergoing explantation and capsulectomy for BII with a control group that underwent implant exchange, finding that the BII group had a six-fold higher rate of positive cultures. The most common organisms they reported were Propionbacterium acnes in 24% of the BII group, followed by Staphylococcus epidermidis in 6%. Cultures were obtained by grinding a portion of the divided capsule sent directly for microbiological analysis as well as part of the implant shell, a method which may have a greater yield for detection of microorganisms within a biofilm structure compared to the routine cultures obtained in our study, and these elaborate methods merit further investigation to elucidate the role of a potential indolent infection as a cause for BII.

Our study is limited by its retrospective nature and lack of standard documentation, without which we were unable to evaluate changes in specific symptoms after explantation or correlate capsular findings on pathology with symptom severity preoperatively. Like prior studies of explantation as a treatment for patients presenting with systemic symptoms, our study is additionally challenged by the subjective bias of defining BII symptoms, lack of a control group, and selection bias as patients were predominantly self-referred to our office for explantation. Follow-up duration was also a mean of 6 months, which limits our ability to predict long-term symptom resolution or recurrence.

Nonetheless, we found that evidence of acute or chronic inflammation was significantly more common in silicone compared to saline and textured compared to smooth implants. This interesting finding potentially suggests an association between a specific implant composition and development of symptoms described as BII. We also found that implant removal with capsulectomy had a low complication rate, and that the majority of patients expressed satisfaction with their postoperative outcomes as well as improvement in their overall symptoms during the follow-up period. Building on the results of our retrospective study, we are currently conducting a prospective study focusing on standardized comparison of preoperative symptoms and postoperative improvement to determine which patients would most likely benefit from implant removal and capsulectomy.

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