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Review Papers

Evaluating the Necessity of Capsulectomy in Cases of Textured Breast Implant Replacement

Swanson, Eric MD

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doi: 10.1097/SAP.0000000000002301
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Abstract

In this review, the role of capsulectomy in asymptomatic patients with textured implants is considered. The clinical relevance is huge because it is estimated that 3 million women in the United States have textured implants.1

The existing literature is largely devoted to capsular treatment in the setting of capsular contracture, which remains the most common indication for reoperation after breast augmentation.2 Manufacturer core studies reveal that Baker grade III/IV capsular contracture rates are in the range of 8% to 19% for primary augmentation,3–8 with no recent trend.9 Many women considering explantation or implant replacement for other reasons have some degree of capsular contracture.

Breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) has created a renewed interest in the role of capsulectomy at the time of explantation or implant replacement. There is a legal consideration as well. With law firms initiating legal action on behalf of women with textured breast implants, there is a need for information regarding the necessity for this procedure.

A constellation of systemic symptoms known as “breast implant illness” has motivated many women to have their implants removed (this term replaces the old description “human adjuvant disease,” which was similarly challenging to define.10). The role of capsulectomy is unclear in this patient group because there is no known physical cause for this entity. Whether the implant is responsible or the capsule, or both (or none), is unknown. Removal of the capsule is not consistently followed by disease remission.11

On July 24, 2019, the US Food and Drug Administration (FDA) requested a recall of Biocell (Allergan plc, Dublin, Ireland) textured breast implants and tissue expanders.12 Allergan issued a global withdrawal of these products on the same date.13 The FDA did not recommend that asymptomatic patients have their implants removed “because of potential risks.” Allergan has represented that the FDA recommends against implant removal.14 This point is included on a popular patient Web site devoted to BIA-ALCL,15 but it is not accurate. Recommending not to remove is not the same as not recommending to remove.14

The FDA's reluctance to recommend explantation is not because the FDA considers the implants safe, but rather because the risk of surgery may exceed the risk of keeping the implants.12 The FDA does not specify those risks, which are related to the type of procedure that is recommended, nor does it make a statement regarding the role of capsulectomy in asymptomatic patients. It is therefore incumbent on plastic surgeons to carefully consider the recommendation for capsulectomy so that a risk/benefit analysis may be possible.

METHODS

An electronic literature review was performed to identify publications that discuss capsulectomies in breast surgery. The search terms “capsulectomy,” “capsulotomy,” and their plural forms were entered into the PubMed search engine.16 “Capsulotomy” was included because this is the alternative procedure to a capsulectomy. The search included all articles published in English through December 2019. Closed capsulotomies were excluded, with the exception of one article that also discussed open capsulotomies.17 Additional selected articles discussing capsular treatment without these key words in the title were also reviewed.

RESULTS

A total of 16 articles on the subject of capsulotomy,17–32 22 articles on capsulectomy,33–54 and 19 other discussions of capsule treatment were identified.55–73 Many of these articles reported technical preferences when performing a capsulotomy18,20,26,28,29 or capsulectomy.35,38,44,49 Most articles discussed the treatment in relation to breast capsular contracture. Capsulectomy was widely endorsed.22,35,36,42,50,60–62

No randomized trials or prospective studies have been published. Because of the heterogeneity of the data and lack of controlled or comparative studies, a meta-analysis was impossible. Only one systematic review was identified,72 comparing recurrent capsular contracture rates after open capsulotomies versus capsulectomies, finding them comparable (0%–54% vs 0%–53%, respectively), although the variability was too great to ensure reliability. Moreover, the implant style was a confounding variable.30 Only one head-to-head comparison of open capsulotomy versus capsulectomy in patients receiving the same implant style (albeit second generation) has been published, finding similar recurrence rates (34% and 31%, respectively).57

DISCUSSION

Histopathology of the Breast Capsule

The capsule is described as a foreign-body response containing macrophages, giant cells, fibroblasts, and, in the presence of silicone gel implants, silicone particles in a collagen matrix.46 Thomsen et al58 found increasing numbers of fibroblasts, lymphocytes, and silicone droplets as the silicone concentration increased in capsular biopsies in women with unruptured second-generation silicone breast implants. The authors believe that silicone devices provoke an inflammatory response not only because they act as foreign bodies but also because of silicone leakage through the elastomer shell.

Copeland et al59 reported that capsules that formed around textured implants typically had silicone fragments present either in extracellular spaces, in vacuolated histiocytes, or in granulomas in surrounding fibroadipose tissue. These findings were not present in capsules associated with smooth implants. Pericapsular tissue often displayed exuberant reactive synovial metaplasia. Most capsules surrounding textured saline implants (85%) contained large silicone fragments within giant cell granulomas. Silicone was recognized microscopically as fragments measuring up to 1 mm in diameter within foreign-body giant cells. The silicone was entirely intracellular and compact, unlike “gel bleed” silicone, which usually appears as diffuse extracellular material or in microvesicular form within histiocytes.59 Capsules surrounding smooth silicone gel implants showed no synovial metaplasia. Silicone was present in extracellular spaces or in vacuolated histiocytes or both.

Melmed40 found that 100% of capsules contained silicone in women whose silicone gel implants and capsules were removed. All but one polyurethane-covered implant had no foam attached to the outer shell. Vacuoles in the capsule were presumed to be polyurethane foam.

Fate of the Capsule

Thomson56 reported that capsules surrounding implanted silicone rubber blocks resolved within 4 weeks after removal of the foreign body in guinea pigs. Friedman et al66 examined capsules that formed around smooth injection ports and textured tissue expanders in rats. The capsules contracted and dissipated within 1 year. The authors concluded that a capsulectomy may be unnecessary when saline implants are removed.66

Hardt et al61 reported that retained implant capsules in women may result in a spiculated mass suspicious for carcinoma, dense calcifications that obscure neighboring breast tissue on imaging studies, or a cystic mass due to persistent serous effusion, hematoma, or encapsulated silicone-filled cysts. Rockwell et al62 reported 8 women with persistent capsules 10 months to 17 years after silicone gel breast implant removal. Unlike the series reported by Hardt et al,61 none of the capsules were suspicious for carcinoma. The capsules did not contain cysts or dense calcifications. These authors questioned the significance of persistent capsular tissue.62

Biofilm and Capsular Contracture

The prevailing theory for capsular contracture has been a subclinical infection harbored in the biofilm.68 However, there are problems with a purely infectious etiology of capsular contracture.30 Positive and negative bacterial cultures from implants and capsules have been obtained from women with and without capsular contractures.74–80 Jacombs et al80 detected 20-fold (72-fold in vitro) more bacteria attached to textured implants than smooth implants in their porcine model, and more growth of biofilm, despite similar capsular contracture rates. Poppler et al,81 using specialized cultures and scanning electron microscopy in women undergoing expander/implant exchange, were unable to find a correlation between biofilm formation and capsular contracture.

The limitations of an infectious etiology are evident in the clinical findings of the only recent study of patients treated for capsular contracture with open capsulotomy.30 An open capsulotomy leaves all of the capsule (and biofilm) in the patient, virtually guaranteeing treatment failure if infection is the cause. However, this simple maneuver is 77% effective after one release and 97% effective after 2 capsulotomies. The success rate is even higher in patients with intact implants, in whom free silicone gel is not a factor; 86% had no recurrence.30 Although inexpensive smooth saline implants have long been considered inferior aesthetically, their more innocuous effect on the capsule represents an important and underappreciated advantage.30

Biofilm and BIA-ALCL

Recent studies have focused on the role of biofilm as a cause of BIA-ALCL.82 Hu et al83 found 4.7 × 106 bacteria/mg in the BIA-ALCL samples (n = 21) versus 4.9 × 106 bacteria/mg in the nontumor capsule specimens from patients with capsular contracture (n = 62). The nontumor samples from patients with capsular contracture but without BIA-ALCL actually contained more bacteria than the BIA-ALCL samples, though probably not significantly.

Walker et al84 recently reported no consistent differences in bacterial profiles (microbiomes) between patients with breasts affected by BIA-ALCL and contralateral control breasts and no significant difference in the relative abundance of gram-negative bacteria, including Ralstonia pickettii, although the number of BIA-ALCL patients (n = 7) was small. Koch's postulates for an infectious etiology have not been satisfied in that bacteria have not been present in every case of the disease.9 Importantly, there is still no known case of a bacterial endotoxin causing a T-cell lymphoma.85

The Role of Pathologic Examination of the Breast Capsule

Many plastic surgeons routinely submit the capsulectomy specimen for pathologic examination.50 In many institutions, it is obligatory operating room policy.50 Roth et al50 studied 434 capsulectomy specimens from 264 patients. The majority (78.0%) were normal. Abnormal but benign findings including inflammation, calcification, granuloma, and necrosis were identified in 21.6% of patients. No patient was found to have a new neoplasm, occult disease, or other clinically significant findings that changed the patient's medical or surgical treatment. The authors concluded that it is unnecessary to submit capsulectomy specimens for pathologic examination in cases of capsular contracture, explantation, or implant exchange. However, patients presenting with symptoms or signs of disease (eg, swelling, tenderness, mass) do require pathologic examination.50 By eliminating routine pathologic examinations in asymptomatic patients, healthcare costs may be reduced.50

Lapid et al53 reported the pathologic findings for 2574 capsulectomy specimens in women who did not have a history of breast pathology and who underwent revisions or explantation after breast augmentation. In 2134 cases (82.9%), the findings were negative for any pathology. In 27.3% of patients, silicone deposits were detected. Calcifications were found in 14.6% of patients. Four cases of invasive carcinoma (0.16% of patients) and 5 cases of in situ carcinoma (0.2%) were discovered. The authors concluded that the frequency of occult malignancy is sufficiently low so as to justify leaving breast capsule tissue in situ (and also eliminating pathologic examination).53

In symptomatic patients requiring capsulectomy for BIA-ALCL, Miranda86 emphasizes the importance of analyzing multiple sites of the capsule. He recommends 12 biopsy sites to achieve a 95% confidence level for detecting a BIA-ALCL tumor.

Particle Theory

The particle theory for the genesis of BIA-ALCL has gained support recently.87 Allergan Biocell implants shed more particles than other textured implants.88 Santonelli di Pompeo89 believes that the surgeon is not just implanting 2 foreign bodies when inserting textured Biocell implants, but as many as 800 foreign bodies, accounting for the silicone microparticulates, creating a “chronic immunologic storm.” The immunological effect of silicone shedding from the textured shell is clearly different, and more dangerous, than silicone bleed into the tissues, which has been known for decades, and, before the advent of textured devices, did not seem to trigger BIA-ALCL.

A remaining puzzle is the relatively high incidence of BIA-ALCL in the presence of (textured) polyurethane implants,90 which do not shed silicone particles, but do shed polyurethane particles. In these implants, the polyurethane foam on the surface disintegrates within 5 years,91 leaving an exposed smooth silicone elastomer. These implants entered the marketplace in the 1970s, more than a decade before textured silicone implants, and have been used widely.91,92 The first case of BIA-ALCL was reported in 1997.93 If polyurethane particles can cause BIA-ALCL, why were no cases of BIA-ALCL reported earlier?

Evaluating the Need for Textured Implant Replacement

Women who have received textured implants, particularly Biocell implants, wish to know their options. In recognition of the need for an informed response, McGuire et al94 published answers to common questions from plastic surgeons and patients. The authors reiterated the FDA position that it “does not recommend removal for patients without symptoms due to potential risks.” The authors acknowledge that there is no scientific evidence to support a complete capsulectomy in the absence of malignancy or capsular contracture. However, they also suggest that “because of anxiety related to their textured implant and potential for development of ALCL, the aim is to perform a precise complete or partial capsulectomy unless intraoperative findings do not allow this to be performed safely.” The authors recommend sending capsular tissue for pathologic examination, even in asymptomatic patients who may need to pay for this microscopic analysis.

Roberts et al95 recently published their experience notifying women with both smooth and textured implants of their BIA-ALCL risk. Patients were cautioned that replacement of textured implants with smooth devices may not eliminate the risk of BIA-ALCL. Of the 264 women with textured implants, 16 women contacted the plastic surgery clinic, and 9 proceeded with implant removal (2 patients) or replacement (7 patients). The surgery fees were discounted or waived.95

Implant Replacement Without Capsulectomy

The risk of implant removal or replacement without a capsulectomy is very low,30 largely limited to the anesthesia risk (approximately 1:100,000 in the United States96), which is lower than the lifetime risk of developing BIA-ALCL (approximately 1:1000).97 A death occurring as a complication of implant replacement without capsulectomy has not been reported. Patient recovery after implant removal with or without replacement is not difficult. Patients often return to work within a few days.30

A recommendation for textured implant replacement without capsulectomy comes with a caveat. In the unlikely event that capsular pathology is discovered during surgery, such as unusual thickening or granulation tissue, the surgical plan may be altered to include capsulectomy and pathologic examination of the tissue.

If BIA-ALCL is diagnosed early, the likelihood of cure is excellent.98 Clemens1 believes that ideally, 85% of women can be diagnosed before the disease has spread beyond the capsule, at a time when implant removal and total capsulectomy are still likely to be curative without a need for radiation or chemotherapy. Unlike many other forms of cancer, undertreatment of an asymptomatic patient (ie, leaving capsular tissue in situ in a rare patient who later develops BIA-ALCL) may be an acceptable option as opposed to overtreatment (capsulectomy in a patient who is not destined to develop BIA-ALCL) with its attendant morbidity. There is a “plan B,” if needed.

Capsulectomy

In 1998, Young42 endorsed capsulectomy to reduce the risk of unnecessary future biopsies of a retained capsule. However, he believed that thin, flimsy capsules and submuscular capsules without calcification did not require removal because they are likely to be resorbed. Spear36 discouraged total capsulectomy in patients with submuscular implants.

Young42 recommended removal of thick, fibrous capsules because they are less likely to resorb and may produce palpable breast masses and/or mammographic artifacts. Another (historical) rationale for capsulectomy is to produce a fresh tissue interface for a new textured implant,42,45 although this interaction is now known to be potentially harmful.

Most surgeons, including the author,30 agree that removing a calcified capsule is warranted (Fig. 1). Such capsules are uncomfortable for women and have social implications. Affected women may resist hugging other individuals. Capsulectomy in patients with calcification may reduce the risk of morbidity related to future biopsies.48 Fortunately, distinguishing between capsule calcification and microcalcifications associated with carcinoma of the breast is rarely a problem for mammographers, but a calcified capsule can obscure areas of breast tissue.42 Calcified capsules are usually easy to remove (Figs. 1, 2) because there is often a distinct plane separating the capsule from the surrounding tissue.42

F1
FIGURE 1:
A and C, This 49-year-old woman had Baker grade IV capsular contractures around 30-year-old prepectoral silicone gel implants. She elected to have her implants replaced and capsulectomies. The implants were removed with the capsules intact around them (Fig. 2). A dissection plane was easily established between the capsule and the surrounding breast tissue. New smooth, round saline implants (Mentor Corp, Irvine, Calif) were inserted in a new subpectoral pocket and inflated to 375 mL on the right side and 425 mL on the left side. Her breasts were soft postoperatively and her pain was relieved. B and D, She had no evidence of a recurrent capsular contracture 4 months postoperatively. Note that this case is an example of explantation and total capsulectomy, not “en bloc” capsulectomy, which would not be indicated in the absence of BIA-ALCL and would also include a cuff of normal tissue.
F2
FIGURE 2:
This intraoperative photograph shows the implants and capsules of the patient in Figure 1. The right capsule was intentionally opened after its removal, revealing a second-generation smooth silicone gel implant. The manufacturer and volume are unknown.

There are no known systemic benefits of capsulectomy.42 Systemic symptoms thought to be related to the implant or capsule are often unrelieved by explantation and capsulectomy.42 Many surgeons believe that the risk of recurrent capsular contracture is reduced by capsulectomy42,45,52 and that capsulectomy is the procedure of choice,42,45,46,52 although this conventional wisdom has been challenged.30

Surprisingly, no large series of consecutive cases and complication rates after capsulectomy has been published. A capsulectomy is a much more traumatic procedure than a capsulotomy. A complete capsulectomy includes stripping capsular tissue off the chest wall and a dissection that can reach well into the axilla. Attempted removal of the axillary portion of a capsule risks damage to the brachial plexus and axillary vessels.42,50 Injury to the axillary vein and death have occurred.99 Young42 recommends leaving any axillary extension of the capsule in place, believing that the remnants will resorb anyway and are unlikely to affect future mammography. Hematomas, nerve injury, muscle damage, increased bleeding, and pneumothorax are all well-known complications.1,29,30,42,43,50,52,60,61,98–101 Other problems include skin perforation, contour irregularities, and chronic rib pain.99 Removal of a prepectoral capsule (Fig. 1) is typically less complicated than a subpectoral capsule.42,99 However, in the setting of subcutaneous mastectomies or breast reconstruction, removing the capsule may jeopardize blood supply to the skin49,50 and compromise nipple and areola viability.1,42 Many surgeons avoid capsulectomies in such patients.60

Submuscular implant capsules often adhere to the ribs and intercostal muscles.61 Most surgeons performing capsulectomies leave some capsular tissue behind, particularly the posterior capsule,35,52 raising the question regarding the need for a capsulectomy (and pathologic examination50) in the first place, if not all of the suspect tissue is to be removed.30 It is interesting to consider the logic in recommending against textured implant removal, but insisting on capsule removal and pathologic examination in those patients who request explantation. If capsular examination is essential, so is the surgery.

Capsulectomy increases the operating time about an hour, along with the expense.42,61,101 Additional breast tissue resection is inevitable, which is poorly tolerated in lean women without much breast tissue to start with (the reason for the breast implants). Pain and recovery time are increased.5 Women may begin as cosmetic patients and then become reconstructive patients as their traumatized breasts heal with scarring.

For asymptomatic patients with concerns about their risk of BIA-ALCL or breast implant illness, many surgeons advocate routine capsulectomy whenever possible.99 Lawrence102 notes that many women simply demand capsulectomies. In the absence of symptoms or signs of any breast pathology, the author does not comply with this request. Patients are informed of the risks of capsulectomy, the fact that it is often incomplete anyway, and the lack of scientific support. No doubt many seek this treatment elsewhere. Others (Fig. 3) are comfortable proceeding with explantation or implant exchange without a capsulectomy.

F3
FIGURE 3:
A and C, This 29-year-old woman had undergone a breast augmentation using 550 mL smooth, round silicone gel implants (Mentor Corp) 1.5 years previously. She elected to have her implants removed because of concerns regarding health risks, although she was asymptomatic. She also requested removal of her breast capsules. B and D, After being informed of the lack of a proven benefit and the possible risks associated with capsulectomy, she elected to have explantation only and was pleased with her result 1 month after surgery.

Removal of textured implants and capsulectomy is often assumed to provide optimal protection against the future development of BIA-ALCL. However, at least 4 cases of BIA-ALCL have occurred in women who previously underwent capsulectomies for capsular contracture (not for BIA-ALCL) with simultaneous replacement of textured implants with smooth devices.103 The completeness of the capsulectomies is unknown. Clemens1 disputes the value of a “prophylactic capsulectomy.” No data support a reduction in BIA-ALCL risk. Surgical treatment of a capsule that has occult disease might contribute to its dissemination.103

By contrast, a capsulectomy is universally recommended for women who are diagnosed with BIA-ALCL.1,98,99,103–106 The rationale for a routine capsulectomy in a patient with capsular contracture is much less clear.30 It has long been assumed that the capsule contains infected biofilm and must be removed.2,30,107 However, the case for bacteria causing capsular contracture (or BIA-ALCL) is largely circumstantial and unproven.30

“En Bloc” Capsule Removal

Unfortunately, there has been a rise of opportunists advertising “en bloc” capsule removal for women with textured implants,1,54 capitalizing on women's fear of this disease. An en bloc resection removes the breast implant, capsule, and a margin of breast tissue.1,54 Intercostal muscle may be removed simultaneously, exposing the lung.1 Clemens1 reports the risk of a pneumothorax is 4%. This oncologic operation should be reserved for patients with a diagnosis of BIA-ALCL.1,54,108 In an asymptomatic patient, plastic surgeons should not routinely perform an operation that adds unnecessary risk and expense.30,54

In considering today's controversy, it is useful to consider the first breast implant crisis of 1992. That year, McKinney109 wrote, “In the midst of the plaintiffs' attorneys, the media, and some plastic surgeons' greed, the patients have been forgotten. If we can take the time to counsel an individual with implants who is concerned, we can restore our image with the public. To advise action in the midst of a storm to sell a procedure is wrong. This crisis is the opportunity to restore the patient as our center of focus.”

This letter was followed by another, titled “Capsulectomy – Medically or Legally Indicated?” Becker34 wrote, “The breast implant crisis has caused fear and panic in many unfortunate patients. Patients are now receiving information from organizations such as Command Trust Network, lawyers, and the media that implant removal is a complicated procedure costing $3000 to $6000, complete capsulectomy should always be performed, and only certain doctors are specialized enough to perform this complex surgery.” Plastic surgeons “should not be coerced into performing capsulectomy because we might be at greater legal risk if we do not!” (author's exclamation point). “We have a duty to help these patients from being exploited and encouraged to undergo expensive/complicated procedures that in actual fact are of more benefit to special-interest groups than they are to the patients.”34

Risk/Benefit Analysis

The current estimated lifetime risk of BIA-ALCL in patients with Biocell textured implants is approximately 1:1000.97 This figure is extrapolated from a 1:2200 risk reported by McGuire et al110 (supplemented with 4 postpublication diagnoses1) and a mean interval from implantation to diagnosis of 8 to 10 years.98 For reconstruction patients, the BIA-ALCL risk according to the series reported by Cordeiro111 is 1:322. A risk/benefit analysis largely rests on whether or not a capsulectomy is performed. If a simultaneous capsulectomy is recommended in an asymptomatic patient, the risk/benefit balance may tilt against having surgery, making any possible advantage of capsulectomy (as opposed to a capsulotomy and implant removal/exchange) a moot point.

The decision to operate may be affected by other considerations, such as a possible existing capsular contracture, breast asymmetry, or the need for a mastopexy or an unrelated cosmetic surgical procedure requiring anesthesia. In addition to BIA-ALCL risk, Biocell implants have many other deficiencies that are remedied by their removal, as enumerated by Van Slyke et al.112 These problems include pain (21%), malposition, double capsules, seromas, and capsular contractures.

According to McGuire et al,94 BIA-ALCL has occurred in women who underwent explantation without a capsulectomy. However, in these cases, the women all had a seroma at the time of implant removal and were likely to have already developed BIA-ALCL.94 One might consider the possibility that the textured implants have already silently triggered BIA-ALCL in asymptomatic patients, but there is no evidence of that. Logically, the sooner the textured implants are removed, the less chance there would be of developing this illness in the absence of a continued triggering agent.

Financial Considerations

The financial considerations are highly relevant to patients. Although some insurance companies in the United States cover the cost of implant removal and medical treatment of patients who develop BIA-ALCL, they do not cover the costs of prophylactic implant removal or exchange in undiagnosed patients.113 A 30-minute implant exchange may be financially feasible for a patient. On the other hand, a 90-minute implant exchange and bilateral capsulectomy may be financially prohibitive. Any hypothetical extra benefit from a capsulectomy is lost if women forego implant replacement altogether.

CONCLUSIONS

Capsulectomy is not mandatory for asymptomatic patients. This procedure carries morbidity and adds substantially to the surgical risk. Implant removal or exchange for smooth implants without a capsulectomy may be an acceptable choice for many women who do not exhibit evidence of capsular pathology. However, any symptoms or surgical findings suggesting pathology warrant a capsulectomy. En bloc resections are reserved for patients diagnosed with BIA-ALCL.

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Keywords:

capsulectomy; textured breast implant; BIA-ALCL; ALCL; breast implant associated; anaplastic large-cell lymphoma; implant replacement; breast implant illness; capsular contracture; explantation; breast capsule; pathologic examination

Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.