Breast implant explantation: indications and strategies to optimize aesthetic outcomes

Capsular contracture

Capsular contracture is one of the most common complications after breast implant placement and is reported to occur in 2.8% to 18.9% of patients after primary augmentation mammaplasty. In a recent review of 1500 patients with 25 years of follow-up, capsular contracture accounted for greater than 55% of re-operations. While there has been significant focus regarding the pathogenesis of capsular contracture and how to mitigate this risk with surgical techniques or implant characteristics, these topics fall beyond the scope of this chapter. Instead, here we focus on the role of implant removal, with or without total capsulectomy, for Baker class III and IV capsular contracture.

The management of capsular contracture has advanced significantly from the initial descriptions of closed capsulotomies in the mid-1970s, often plagued with high recurrence rates and concerns for implant rupture. Over the past 20 years the traditional teaching for the treatment of Baker grades III and IV capsular contracture has been total capsulectomy with implant removal and replacement. The evidence behind this paradigm was investigated by Wan and Rohrich in a meta-analysis published in 2016. In their study, they showed that implant exchange, site change, and possible addition of acellular dermal matrix were significantly associated with decreased capsular contracture recurrence rates. However, the evidence for total capsulectomy when compared with simple or partial capsulectomy was “weak at best”. This is of particular concern when managing patients with subpectoral implants because total capsulectomy in these patients is associated with a higher rate of pneumothorax and chest wall injury. Given this, some authors have demonstrated success with low capsular contracture recurrence rates with anterior capsulectomy for subpectoral implants or with the creation of a neosubpectoral pocket superficial to the previous capsule, however deep to the pectoralis muscle. Regardless of the specific operative technique, implant exchange should be employed to reduce the incidence of capsular contracture recurrence.

Implant rupture

Silicone implant rupture is of particular concern because it can be difficult to diagnose and may have complicating effects if not recognized. While the downstream effects of silicone implant rupture have been slightly mitigated with the employment of highly cohesive gel implants, the concern of silicone leaching into the surrounding breast tissue and breast implant capsule after rupture remains. When introduced to the surrounding tissues, silicone granulomas may form which can lead to lead to infections, lymphadenopathy, and contour irregularities, all of which are potentially challenging to correct. ^14,15 Given this, the early detection of implant rupture is of utmost concern. To date, there is no clear consensus on the best method and optimal timing to detect and screen for “silent rupture”. At this time, the US Food and Drug Administration (FDA) recommends screening ultrasound or MRIs of silicone implants 5–6 years after placement and every 2–3 years thereafter; however, insurance coverage for these procedures can vary. Several studies have suggested the benefits and efficacy of using ultrasound performed by skilled ultrasonographers with or without mammography to determine implant integrity, but widespread use of this technique has not occurred. What is clear is that after silicone implant rupture is detected, explantation of the implant is warranted. If the silicone remains confined to the implant and capsule (intracapsular rupture) with no capsular changes, then implant removal alone with or without replacement may be appropriate. If the capsule is found to be thickened, calcified, or has significant silicone nodules present throughout (extracapsular rupture), a partial or complete capsulectomy may be necessary.

Implant exposure and infection

Although implant exposure and infection continue to be rare complications after breast augmentation and implant-based breast reconstruction, it is vital that plastic surgeons are well versed in the various treatment options available when faced with this dilemma. Certainly, the most conservative and traditional thinking is that implant exposure represented contamination of the entire implant and implant pocket and requires implant removal, washout, and ultimate delayed implant re-insertion. However, given the significant consequences to both aesthetic and psychosocial well-being after implant removal and delayed re-insertion, many plastic surgeons have tried to avoid this approach and make all reasonable attempts at “implant salvage”. In 2010, Spear et al . followed up his 2004 study with a retrospective review of 69 patients treated for implant exposure or infection with a focus on attempts for implant salvage, which was defined as continuous presence of a breast implant throughout the study period – not necessarily the “salvage” of the original implant. The authors demonstrated that techniques such as washout, capsulectomy, and immediate replacement of the implant with a change of plane can lead to successful implant salvage without high rates of post-salvage complications or capsular contracture. By considering implant infection on a continuum ranging from mild skin infection to severe implant exposure with obvious purulent infection, we can begin to make nuanced decisions on the need for explantation with delayed re-insertion versus attempts at implant salvage. Finally, recent advances in acellular dermal matrix and negative pressure wound dressings have further expanded on the idea that not all “implant exposures” are the same, and Accurso et al . reported on their experience salvaging cases of ADM exposure. Ultimately, the decision on how to manage implant exposure and infection must be made on a case-by-case basis and the plastic surgeon must have a low threshold for operative intervention.

BIA-ALCL

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has taken both popular culture and the plastic surgery community by storm and has been the topic of significant controversy and research over the last decade. BIA-ALCL incidence is linked to textured implants and can present as late seroma formation, pain or swelling of the breast, overlying skin changes, or a mass or lump on the affected breast. When presented with these findings in the setting of a known textured implant, it is important to follow National Comprehensive Cancer Network (NCCN) guidelines which establish appropriate imaging, core biopsy or fine needle aspiration with cytology and CD30 immunohistochemistry, and ultimate treatment plans for these patients. Once a diagnosis of BIA-ALCL is confirmed, treatment consists of en bloc resection with or without radiation and/or chemotherapy based on the stage of disease. En bloc resection is defined as explantation in continuity with total capsulectomy surrounded by a healthy rim of tissue, making sure to include all of the capsule, periprosthetic fluid, and associated masses surrounding the implant. En bloc resection has been shown to lead to higher rates of disease-free survival when compared with treatment with radiation, chemotherapy, or standard capsulectomy. It is important to differentiate the role of en bloc resection for patients with confirmed cases of BIA-ALCL from patients who present asymptomatically with textured implants. At this time, both implant manufacturers and various plastic and oncologic surgical societies are not recommending routine implant removal for asymptomatic patients with textured implants but leave it to the surgeon and patient discretion if they would like to proceed with implant removal. There is no government authority, national society recommendation, nor current scientific evidence to support that routine implant removal, with or without capsulectomy, will lead to an eradication of future risk of BIA-ALCL in asymptomatic patients. Although it is possible that capsulectomy reduces the risk of developing BIA-ALCL, there is currently no scientific data confirming any particular risk-reducing procedure once exposed to a textured surface breast implants. With these patients, it is vital for the surgeon to have an evidence-based discussion that outlines the rarity and incidence of BIA-ALCL, describes that BIA-ALCL typically follows an indolent course with surgical resection leading to disease remission in most cases, and acknowledges that our knowledge in this field continues to grow as we learn more about this disease process. Patients should be informed that should they wish to undergo implant exchange from textured to smooth implants, a capsulectomy may not have any effect on ultimate disease progression or survival but may impact the final aesthetic outcome of the surgery. The ultimate decision must be made with their plastic surgeon, weighing the risks and benefits of each, often with limited data to assist in these discussions.

Breast implant illness

Breast implant illness (BII) is another area of controversy within the plastic surgery and patient communities. The potential link between silicone implants and autoimmune diseases, vague complaints of fatigue, malaise, headache, and other non-specific generalized symptoms have been circulating for the last several decades, and the concerns of these symptoms along with the potential link to breast cancer were central to the 1992 moratorium placed on silicone implants. In 1999, the Institute of Medicine published their “Committee on the Safety of Silicone Breast Implants” landmark paper, which reported no existing evidence between silicone implants and autoimmune or oncologic disorders and was instrumental in getting silicone implants re-instated in the US market. While the importance of this study cannot be understated, it was certainly not the end of the investigation or the controversy surrounding silicone implants. In 2019, the Rohrich et al . publication, “Silicone implant illness; science versus myth”, provided a comprehensive review of the evidence behind the potential links between silicone implants and cancer, rheumatologic, neurologic, and connective tissue diseases as well as any potential complications to the children of mothers with silicone implants. The study concluded by saying silicone implants may be one of the most well-studied medical devices to date and that there is “overwhelming evidence to support their safety”. The study rejected the formation of a new illness saying “To the best of our body of scientific knowledge to date, there have not been any concrete or evidence-based studies or peer-reviewed data concerning the formation of a new syndrome: silicone implant illness” but urged for continued ongoing studies to continue to improve patient safety, awareness, and education.

Discussed within the aforementioned Rohrich et al . paper on silicone implant illness, a study by Coroneos et al ., which analyzed the FDA’s large postapproval studies (LPAS) database for Mentor and Allergan implants, warrants further discussion. This study is the largest and most comprehensive epidemiologic study of patient safety and implant-specific outcomes for breast implants in the literature and generated a lot of controversy and concerns for patients and plastic surgeons alike. In their paper, Coroneos et al . reported a statistically significant increase in connective tissue diseases such as Sjogren’s, rheumatoid arthritis, and myositis in women who had silicone implants when compared to the general population. This report was controversial and thus subject to severe scrutiny. The cases of connective tissue diseases and neurologic disease were self-reported by Mentor patients, whereas Allergan patients had to receive a formal diagnosis by a treating physician. The study also reported variable manufacturer follow-up rates with 60% for Allergan and 21% for Mentor at 7 years, a significant limitation in evaluating and developing conclusions that are reliable or valid. As expected, this paper generated a lot of discussion and was met with several responses from prominent plastic surgeons as well as one from Dr. Binita Ashar from the FDA. Many of the responses cited multiple methodologic concerns with using LPAS data to follow rare, long-term adverse events and believe the extremely low follow-up rates could have led to a severe response bias. In a response prepared by Drs. Colwell and Dr. Mehrara, they point out that while there were some associations with systemic harms from both implant manufacturers (Allergan and Mentor), the conclusions tend to overemphasize the smaller patient-reported Mentor data while largely ignoring the larger physician-reported Allergan data. As shown previously, the rates of patient-reported diseases do not always correspond to those with a physician-confirmed diagnosis. This is particularly true and well-studied among connective tissue disorders and rheumatoid arthritis, which have shown only an 8–24% and 21–36% correspondence with physician-confirmed diagnosis, respectively. Finally, the Coroneos paper compares the study population to the US population in general. We know from previous studies that women who have breast implants are demographically distinct from US women as a whole. In particular, this population of women has a higher rate of cigarette smoking, is more likely to have ever been pregnant, and is more likely to have early termination of pregnancy, either from miscarriage or abortion, potentially creating confounders that may have skewed the data. Given all of these concerns, the FDA’s final statement on the Coroneos et al . paper is that they “respectfully disagree” with the conclusions the paper made and “urged the public and healthcare community to view this external assessment’s conclusions with caution”. Despite this statement, in 2019, the FDA made recommendations to add a “Black Box Warning” on breast implants stating that they “have been associated with systemic symptoms” and called for a standardized informed consent and patient checklist with the disclosure of the possibility of a BII for women considering breast implants.

While further studies continue to investigate whether silicone implants are associated with systemic illnesses or a so-called “breast implant illness (BII)”, there may be a role for explantation for patients who present with these concerns. This was shown in a 2017 literature review by de Boer et al . who classified these “silicone related complaints” as fatigue, myalgia, arthralgia, pyrexia, sicca, and memory and sleep disturbances. Pooling 23 different studies, 10 case reports, and 13 cohort studies, they analyzed a total of 622 patients with silicone related complaints who were treated with operative intervention. The review concluded that implant removal led to an improvement of these complaints in 75% of patients but clarified that for autoimmune complaints improvement was infrequent without additional treatment. While there are certainly methodological concerns of this study, it does leave surgeons in a difficult situation when faced with patients with these “silicone related complaints”. At this time, it is certainly reasonable to have a thorough discussion with the patient, informing them that implant removal may or may not lead to resolution of their symptoms and that the surgery has certain risks such as pneumothorax or bleeding and ultimately may create aesthetically poor outcomes after removal. If the patient still desires to undergo implant removal with or without capsulectomy after an appropriate discussion, then it is completely appropriate to offer the surgery ( Fig. 14.1 ).