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Author: Hardt, N. S.; Yu, L.; LaTorre, G.; Steinbach, B.
Address: Dept. Pathology, University of Florida College of Medicine, Gainesville, FL.
Source: Plastic and Reconstructive Surgery Journal, Feb., 1995, 95:2, 364-71

Abstract: Citing evidence that breast implant-related capsules resolve uneventfully, surgeons have elected to leave the capsules in place when implants are removed because capsulectomy adds both morbidity and expense to the procedure. However, recent clinical and histopathologic evidence suggests that uneventful resolution is not always the case, and several potential problems may arise from retained capsules after removal of the implant.
Retained implant capsules may result in a spiculated mass suspicious for carcinoma, dense calcifications that obscure neighboring breast tissue on subsequent imaging studies, and cystic masses due to persistent serous effusion, expansile hematoma, or encapsulated silicone filled cysts. Furthermore, retained capsules are a reservoir of implant-related foreign material in the case of silicone gel-filled implants and textured implants promoting tissue ingrowth. To avoid complications from retained capsules, total capsulectomy or postoperative surveillance should be offered to patients.
Silicone breast prostheses have been used in reconstruction and aesthetic augmentation of the breast since the 1960's. Some patients who are long-term recipients of these devices are now reporting complications necessitating their removal. At the time of surgical removal, the existing implant-related fibrous capsule maybe completely removed by capsulectomy.1 Alternatively, the capsule may be modified to receive a replacement implant, 2, 3 or it may be left in place as a new implant pocket is created either anterior or posterior to the intervening pectoral muscle.4 This practice is supported by animal studies published in 1973 indicating that capsules related to implanted silicone rubber blocks resolved within 4 weeks after removal of the foreign body.5
However, the 1973 studies may not be directly relevant to breast implant- related capsules. That study was performed in guinea pigs, and implant were studied at 10 weeks, 3 months, 6 months and 1 year. Flat, untextured pieces of elastomer were implanted. There was no distension of the elastomer shell with silicone gel or saline. Unlike the guinea pig capsules, gel-filled and most textured breast implants are replaced because of capsular contracture or rupture have foreign material from the implant incorporated into the capsule. The body's attempt to clear that foreign material continues even if the implant is removed.
Disadvantages of capsulectomy at the time of implant removal include increased operative time and blood loss. Retroglandular (submammary) implants develop capsules that impinge on the well vascularized pectoral fascia and muscle, while submuscular (subpectoral) may be adherent to ribs and intercostal muscles. To prevent hematoma, some surgeons remove the anterior wall of the capsule, leaving the posterior capsule in place on the chest wall.4,6
Few authors have addressed the consequences of retained capsules. Palpable or mammographically detected breast masses related to breast implant capsules have been described.7,10 Such masses may be well circumscribed or bilaterally symmetrical, indicating their benign nature, and often have not been excised. Spiculated masses, by contrast, are excised for histopathologic examination to rule out adenocarcinoma. We report five patients with complications associated with retained implant capsules that required removal, facilitating histopathologic correlation with mammographic and clinical findings.
Without Graphics from the article and accompanying notes to them for the below cases. However, we felt the explanation of each case is very enlightening without them!
Case 1
A 53 year old woman developed right breast carcinoma 9 years after breast augmentation with saline-filled implants. Her right saline- filled implant and capsule were removed at the time of radical mastectomy, and the left remained in place. Right breast reconstruction and removal of the left saline implant without capsulectomy occurred at another institution.
Follow-up mammograms of the left breast showed no implant, but wrinkled and calcified mass anterior to the ribs. Microcalcifications in the region of the benign-appearing macrocalcifications were progressive, prompting a breast biopsy. Histopathology of the removed tissue confirmed that benign calcification occurred in the collagenous layers of the former implant capsule.
Case 2
A 49 year-old woman presented 7 years after bilateral subcutaneous mastectomy for fibrocystic disease followed by immediate reconstruction with subcutaneous saline-filled implants. Postoperatively, she developed bilateral capsular contracture. Three years later, she underwent removal and replacement of the saline implants with Meme polyurethane covered silicone gel-filled implants (Natural-Y Surgical, Los Angeles, CA). She developed mastodynia (breast pain) and three years later underwent removal of the Meme implants without reconstruction. Postoperatively, she developed bilateral breast masses.
Xeromammograms revealed bilateral spiculated solid masses with central lucency suggesting a central cysts. Biopsy of one of the masses revealed a stelate fibrous scar of foreign material with associated giant-cell reaction. One year later she underwent bilateral mastectomy with staged reconstruction using tissue explants.
On sectioning the tissue removed at mastectomy, a 4.2 X 2.2 cm (2.4 cm = 1 inch) mass in the unbiopsied breast had a central cystic cavity. The central cyst was lined by smooth fibrous capsule measuring 0.1 cm in thickness. Histopathologically, a breast capsule was identifiable focally, indicating the origin of the cyst. Deep to the retained capsule, numerous triangular fragments of shattered foreign material were identified. These were surrounded by multinucleate giant cells.
Also, identified were intracellular droplets of refractile foreign material consistent with silicone-gel and larger sheetlike fragments of refractile water-clear foreign material resembling silicone-based adhesive or silicone elastomer shell fragments. In other areas, the cyst cavity was not apparent, but solid aggregates of banks of dense connective tissue with associated foreign material could be identified.
Case 3
A 46 year-old woman underwent bilateral subglandular (submammary or under the breast tissue) augmentation mammaplasty 18 years earlier. She developed recurrent capsular contracture requiring multiple bilateral closed capsulotomies. During that time, she had the onset of food allergies, paresthesias, visual changes, fungal infections, joint pains, seizures, memory loss, and myalgias.
Ten months prior to the current surgery she underwent bilateral removal of the implants. At that time she was told she had bilateral rupture, right "worse than her left. The implant capsules were not removed. She then noted bilateral breast masses that prompted self-referral to this institution. Xeromammogram revealed calcifications bilaterally, apparently in the distribution of the retained capsules. In association with the right-sided calcifications, a dense, lobular, solid appearing mass was noted.
Ten months after implant removal, bilateral capsulectomy was performed. On the left, an empty-appearing sac was excised, measuring 12 X 11 X 2.3 cm. On the right, an 11.2 X 4.7 X 5.6 cm lobulated mass with a central cyst containing grossly evident silicone gel was excised. Accompanying the right capsule was a rubbery yellow-gray 2.3 X 1.3 X 1.3 cm pericapsular solid mass that exuded a slippery clear material from cut surfaces.
Histopathologic evaluation of the excised tissue confirmed the presence of a fibrous capsules bilaterally. The right-sided cyst cavity was loculation in the retained capsule and contained water-clear refractile foreign material consist with polydimethylsiloxane gel. Residual capsules lumens were generally smooth but remarkable grossly for occasional translucent, smooth, flat plaques of adherent material with the consistency of calcium. This material was firm to the knife with a tendency to fragment or fracture on cutting.
Light miscrocopically, with the collagen layers of the capsule and in soft tissues deep to the capsule, there were numerous aggregates of mononuclear macrophage-type cells with vacuoles of refractile nonbirefringment foreign material consistent with polydimethylsiloxane. Multinucleate giant cells were present. Dystrophic calcification was linear in orientation, parrallel to the capsular lumen. In addition to the luminal gel, the right rubbery mass adherent to the exterior aspect of the capsule was a silicone granulomas, with droplets of silicone oil surrounded by multinucleate and mononuclear macrophages.
Case 4
A 49 year-old woman presented 12 years after bilateral augmentation mammaplasty with smooth-walled silicone gel-filled implants. Postoperatively, she developed bilateral Baker grade III capsular contractures, as well as the new onset of mastodynia (breast pain), arthritis, skin lesions, and memory loss. Xeromammograms revealed bilateral contained implant ruptures.
She returned to her referring surgeon, who removed the implants under local anesthesia in an office facility. Capsulectomy was not performed. Bilateral rupture of the implants was confirmed at the time of implant removal. Postoperatively, she presented to this institution with bilateral masses that had increased in size progressively.
A xeromammogram revealed bilateral retroglandular smooth-walled masses with marginal dystrophic calcification consistent with retained capsules. She underwent removal of these masses. The collapsed cystic structures had a 0.9-cm residual lumen of the right and a 3.1-cm residual lumen on the left and contained residual blood and silicone gel.
Histologically, the collapsed implant capsule was represented by serpiginous collagen-rich connective tissue structure interspersed with highly vascular granulation tissue and multiple aggregates of mononuclear cells containing refractile foreign material consistent with silicone. The 3.1-cm residual lumen from the left side contained grossly evident silicone gel.
Case 5
A 66 year-old woman with right breast cancer underwent right modified radical mastectomy and left prophylactic mastectomy with staged reconstruction using tissue expanders followed by silicone-containing implants (Dow Silastic II smooth-walled silicone gel). Postoperatively, she developed bilateral capsular contracture, Baker grade IV, which was unresponsive to closed capsulotomy.
Eight years after mastectomy, she developed a recurrent cancer of the right breast and underwent wide local resection of the recurrence and removal of bilateral implants without capsulectomy. Postoperatively, she received chemotherapy and radiation therapy to the right side. Four months after implant removal, she began to notice a progressive increase in size and volume of the left breast. She presented for reevaluation 9 months after implant removal with enlarged left breast that simulated her preoperative clinical appearance with implant in place. Ultrasonogram and xeromammogram findings were consistent with loculated fluid collection in the site of the prior implant.
Eleven months after explantation, she underwent left capsulectomy. The fluid collection detected by palpation and mammography was confirmed to the retained breast implant capsule. A 10 X 10 X 0.4 cm thick fibrous capsule distended with laminated blood clots was removed.
Histopathologically, the capsular space was filled with blood. Early granulation tissue was present on capsular surfaces, in some foci bridging gaps between redundant capsular folds. Numerous hemosiderin- laden macrophages were present, and occasional droplets of refractile foreign material consistent polydimethylsiloxane with were observed.
Patients who have undergone implant removal for clinical or mammographic evidence of implant rupture or systemic complaints have frequently undergone removal of the implant alone without capsulectomy. This procedure maybe done easily and rapidly under local anesthesia in an office setting. The addition of capsulectomy to the procedure may require an inframmary incision and extensive surgical dissection, adding to the attendant risks of a larger operation. Patient discomfort as well as longer operative times create the need for heavy sedation or general anesthesia. The increased costs associated with removal of both the implant and capsule may be prohibitive for some patients.
Since it has been reported that breast implant capsules resolved uneventfully after implant removal,5 and since capsulectomy adds both morbidity and expense to the procedure, many surgeons have elected to leave the capsules in place. However, recent clinical and histopathologic evidence suggests that uneventful resolution is not always the case, and several potential problems may arise from retained capsules after removal of the implant.
Histopathologic examination of retained capsular tissues provides evidence of the body's continuing attempts to resolve the capsule and process the foreign material after removal of the implant. Collapse of the capsule with the appearance of granulation tissue in the lumen indicates that healing will gradually obliterate the dead space.11 This resolving mass may present as a palpable cystic mass that my tend to persist if blood, serous fluid,7 or retained silicone gel prevents apposition of the capsule walls and resolution of the cyst. In cases where no cyst formation is clinically apparent, calcification of the residual capsule wall may manifest as progressive microcalcifications mimicking malignancy (as in Case 2). Dystrophic macrocalcifications may obscure underlying breast tissue.
The granulation tissue formed by the body to obliterate the capsular space contains numbers vessels in delicate connective-tissue stroma that may be disrupted by shearing forces of one capsule sure over the other. Tearing of these vascular structures may predispose to hematoma formation, as in Cases 4 and 5, when retained capsules became clinically apparent as enlarging masses. The hematoma may appear after the perioperative period, as in Case 5 (4 months later), when thrombocytopenia occurred during chemotherapy with bone marrow-- suppressing chemotherapeutic agents. However, hematoma formation is not restricted to patients with bleeding disorders (Case 4).
In addition to silicone gel incorporated into the capsular tissue, pockets of silicone gel may be noted on inspection of cyst contents long after removal of a rupture implant (Cases 2 and 3). This reservoir of gel continues to be processed by cells of the reticuloendothelial system. Silicone gel has been known to accumulate in regional lymph nodes, occasionally resulting in clinical concern. The ultimate fate of the retained silicone is not known. In the case of polyurethane foam- covered implants, as well as other textured implants promoting tissue ingrowth, some of the texture is left embedded in the pericapsular soft tissue. The metabolic fate and chemical nature of the by products of hydrolysis are under study.
In the case of implant removal with total capsulectomy, patients must be made aware that the potential exists for silicone to be retained in various tissue sites postoperatively. Implant removal and capsulectomy address the localized foreign material adjacent to the implant. Foreign- body granulomata elsewhere in the breast tissue, chest wall, and axilla, or regional lymph nodes that may bear deposits of silicone are not addressed with this operative approach.
In summary, retained implant capsules may result in a spiculated mass suspicious for carcinoma, dense calcifications that obscure neighboring breast tissue on imaging studies, and cystic masses due to persistent serous effusion, expansile hematoma, or encapsulated silicone filled cysts. Retained capsules are a reservoir of retained foreign material. These cases illustrate a spectrum of clinical problems associated with retained implant capsules.
In some patients, late complications offset the short-term gain in operative time and morbidity when capsules are left in place. Patients whose implants are ruptured or leaking and whose intact textured implants promote tissue ingrowth may benefit most from capsulectomy at the time of implant removal. Patients and surgeons who elect to leave capsules in place may prefer plan of follow-up surveillance with physical examination and imaging studies.
Department of Pathology
University of Florida College of Medicine
Gainesville, FL 32610
This work was supported in part by the Diagnostic Referral Laboratory, Department of Pathology, University of Florida College of Medicine, Gainesville, Florida, and by a grant from the Plastic Surgery Educational Foundation.
1. Williams, J. E., EXPERIENCES WITH LARGE SERIES OF SILASTIC BREAST IMPLANTS, Plastic & Reconstructive Surgery Journal, 49: 253, 1972.
2. Freeman, B. S., SUCCESSFUL TREATMENT OF SOME FIBROUS ENVELOPE CONTRACTURES AROUND BREAST IMPLANTS, Plastic & Reconstructive Surgery Journal, 50: 207, 1972.
3. Cronin, T. D., and Greenberg, R. L., OUR EXPERIENCES WITH THE SILASTIC GEL BREAST PROSTHESIS, Plastic & Reconstructive Surgery Journal, 46: 1, 1970.
5. Thomson, H. G., THE FATE OF THE PSEUDOSHEATH POCKET AROUND SILICONE IMPLANTS, Plastic & Reconstructive Surgery Journal, 51: 667, 1973. 6. Keyser, J. J., CAPSULECTOMY LOCAL ANESTHESIA BY CAPSULAR INSUFFLATION (Letter), Plastic & Reconstructive Surgery Journal, 90: 1130, 1992.
8. Stewart, N. R., Monsees, B. S. Destouret, J. M. and Rudloff, M. A., MAMMOGRAPHIC APPEARANCE FOLLOWING IMPLANT REMOVAL, Radiology, 185: 83, 1992.
9. Hayes, M. K., Gold, R. H., and Bassett, L. W., MAMMOGRAPHIC FINDINGS AFTER THE REMOVAL OF BREAST IMPLANTS, A. J. R. 160: 487, 1993.
11. Ryan, G. B., Cliff, W. J., Gabbiani, G., Irle, C., Montandon, D., Statkov, P. R., and Majno, G. MYOFIBROBLASTS IN HUMAN GRANULATION TISSUE, Hum. Pathol. 5: 55, 1974.

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