CLINICAL FEATURES OF LOCAL BREAST PHENOMENA

IN 300 SYMPTOMATIC RECIPIENTS OF

SILICONE GEL-FILLED BREAST IMPLANTS

ARTHUR E. BRAWER

Department of Medicine

Division of Rheumatology

Monmouth Medical Center

Long Branch, New Jersey

Aims: To define the subjective and objective breast area problems encountered in clinically symptomatic recipients of silicone gel-filled breast implants. Methods: Three hundred patients who became systemically ill following insertion of silicone gel-filled breast implants were examined. The mean age at the time of implantation was 33 years, and the average silicone gel device exposure spanned 12 3/4 years. Results: Two hundred and ninety-seven patients experienced multiple local breast phenomena including itching, rash, burning, numbness, coldness, pain, hardening, bogginess, displacement, puckering, sagging, nodularity, slow shrinkage, or overt rupture. A key clinical event was failure of the capsule which occurred on average five years from the time of initial implantation, which in turn was the forerunner of subsequent rupture. Rupture occurred in 214 cases (71%) at the average rate of 5% per year, preceded systemic disease onset in only nine patients (3%), and occurred as a single local event in only four patients (1%). Conclusions: In this cohort of silicone gel breast implant recipients, clinically apparent local breast phenomena exhibited chronological order to each other and manifested an integral relationship to systemic disease development and progression.

1. Address all correspondence to: Arthur E. Brawer, M.D., 170 Morris Avenue, Long Branch N.J. 07740. Tel.: (732) 870-3133. Fax:(732) 222-0824.

2. Key words: Breast implants and silicone.

3. Presented in part at the 20th Northeast Regional Meeting of the American College of Rheumatology, June 3-5, 1994, New York, NY.

4. Disclaimer: Dr. Arthur E. Brawer has examined patients at the request of plaintiffs' attorneys, has received compensation from plaintiffs' attorneys for these examinations, and has testified at depositions and at trials on behalf of plaintiffs involved in silicone gel breast implant litigation.

Journal of Clean Technology, Environmental Toxicology, and Occupational Medicine, Vol. 5, No. 3, pp. 235-247

Copyright ® 1996 Princeton Scientific Publishing Co., Inc.

INTRODUCTION

Silicone gel-filled breast implants have been used since 1962 for a variety of reconstruction and augmentation purposes (Cronin, 1964). Clinically recognizable local breast complications have been outlined in several reviews and have predominantly included capsular contracture, rupture, displacement, changes in breast and nipple sensation, calcium deposits, infection, hematoma formation, palpable breast nodules, itching, rash, dehiscence, protrusion and interference with routine mammography. (McGrath and Burkhardt, 1984; Gylbert et al., 1990; Bright, et al., 1993; Burger and Bostwick, 1994; Society for Ultrastructural Pathology, 1995). The purpose of this study was to examine some of these phenomena in a cohort of patients who had become systemically ill following the insertion of silicone gel-filled breast implants.

MATERIALS AND METHODS

Three hundred patients (299 women and one male) who became systemically ill following insertion of silicone gel-filled breast implants were examined. The patients were either self-referred, attorney-referred, or physician-referred. Table 1 lists the indications for surgery, with two-thirds of the women having undergone bilateral cosmetic breast enhancement. Multiple different manufacturing devices were represented in the cohort as a whole. Data were neither analyzed according to the type of implant inserted nor for surgical technique (such as subpectoral location). The average silicone gel device exposure spanned 12   3/4 years, with implantation time ranging from eleven months to 27 years. During this interval, 164 patients had only one set or a single implant inserted and 136 patients underwent multiple implant exchanges. In any patient with a final gel exchange for saline (44 out of 300), the additional saline device insertion time was not counted as part of the total implant exposure time, and local breast phenomena associated with saline devices were not included in the data analysis.

TABLE 1.     General Features and Indications for Surgery

Note: Patient population: 300 (299 women). Age 16-64 (mean 33). Initial insertion from 1967-1991.

The onset of systemic disease symptoms and signs occurred on average 2 1/2 years after implant insertion, beginning as early as two weeks after the implantation or as late as 18 years afterwards. Any single clinical manifestation was included as part of the disease process only if it was chronically unremitting and/or persistently repetitive, was not present prior to device insertion and could not be attributed to any other well-defined medical condition. A single rheumatologist interviewed and examined each patient directly and prior medical records were reviewed whenever

possible. Follow-up was arranged by either reexamination or telephone contact.

Implant rupture was determined by any of the following: obvious signs upon physical examination, positive radiographic procedure, surgical findings, pathology findings, or classical history (such as sudden flattening). For patients with multiple sets of implants, rupture time was calculated only for the set that had failed, not from the total time interval since initial implantation. For example, if a patient underwent implant exchange two years from the time of initial implantation because of painful capsular contracture without rupture, and the second set of implants

subsequently ruptured six years later, the time to rupture was calculated at six years. If a patient experienced rupture in more than one set of implants, the incidence of rupture was counted only once, and the time to rupture was calculated for the first ruptured set (even though data were collected for all events). The relationship between rupture and other local breast phenomena was analyzed, as was the relationship between all local breast phenomena and the onset and progression of the systemic disease.

RESULTS

Four categories of local breast phenomena were identified. These included proximate (postoperative) events, capsular contracture, displacement, and rupture. The proximate phenomena are listed in Table 2, with items in the left column persisting indefinitely in four out of five patients who developed them. Breast rashes were often pruritic and varied in presentation from nonraised erythema to small papules and pustules, an example of which is noted in Figure 1.

TABLE 2.     Local Breast Phenomena, Category One: Proximate (Post-Operative) Phenomena

Note: Span: 1 day to 6wks. 60% (181 out of 300) of patients reported proximate post-operative phenomena

FIGURE 1. Breast rash appearing three weeks after bilateral cosmetic augmentation.

With regards to capsule formation, the pathology, pathogenesis, pathophysiology, and immunopathology of the deposition of fibrocollagenous connective tissue (and its accompanying synovial metaplasia) around a gel implant have previously been described. (Domanskis and Owsley, 1976; Barker et al., 1978; Bergman and van der Ende, 1979; Gayou, 1979; Winding et al., 1987; Thomsen et al., 1990; Dunn et al., 1992; Talcott, 1994; Wells et al., 1994; Del Rosario et al., 1995). Table 3 lists the descriptive phrases used by patients to describe capsular contracture.

Over the years, calcification could occur (Figure 2). Attempts to "soften" the implants via one or more closed capsulotomy procedures were often exercises in futility without any long-term improvements. Capsular contracture often also prompted multiple revision and/or exchange surgeries, only to have the same problem frequently recur with each subsequent set of implants regardless of whether or not capsulotomy and/or capsulectomy was performed at the time of the exchange.

TABLE 3. Local Breast Phenomena, Category Two: Capsular Contracture

Note: 70% (209 out of 300) patients reported pain, tenderness, hardness.

Span: 1 wk-36 mos. (4 mos average).

FIGURE 2. A contracted calcified capsule surrounding a ruptured silicone gel breast implant. Figures 3,4, and 5 are representative of the third category of local breast phenomena. A complete outline of the findings is illustrated in Table 4. The displacement category represents failure of the capsule, which developed a lacy appearance (Blais, Pierre. Personal oral communication), and occurred an average of five years from the time of implantation. Failure of the capsule preceded implant rupture in all but eight of the 214 patients who developed rupture. In particular, the appearance of solitary or multiple breast nodules or cysts invariably correlated with subsequent rupture. Biopsies of these cysts or nodules revealed findings ranging from benign fibrocystic disease to silicone granulomas, depending on both the proximity of these lesions to the implant itself and the amount of remaining breast tissue. The distortion noted in Figure 6, and the slow shrinkage with and without nipple discharge noted in Figures 7 and 8, represent other

manifestations of the displacement category.

TABLE 4.     Local Breast Phenomena, Category Three: Displacement and Miscellaneous

Note: 72% (217 out of 300) patients manifested displacement and miscellaneous phenomena. Span: 2 mos-16 yrs (5 yrs average)

FIGURE 3. Malposition of the right breast implant, with progressive inferior and lateral displacement, in a patient with bilateral cosmetic augmentation.

FIGURE 4. Malposition of the left breast implant, with inferior displacement, in a patient with bilateral cosmetic augmentation.

FIGURE 5. An example of bilateral puckering, rippling, and dimpling.

FIGURE 6. Lateral flattening and slow shrinkage of the right breast and lateral displacement of the left breast, in a patient with bilateral augmentation.

FIGURE 7. An eleven-year history of a viscous cloudy discharge from the left nipple, beginning six months after bilateral cosmetic augmentation.

FIGURE 8. Gel implant shrinkage on the left side following post-mastectomy reconstruction.

The fourth type of local breast phenomena is implant rupture, which occurred in 214 patients out of 300 (71%) and was nearly equally divided into two groups: ruptured original implants and rupture associated with multiple surgeries and exchanges. The shortest time to rupture was two months, with the average rate of rupture calculated at 5% per year, as noted in Table 5. The incidence of rupture was the same in the unilateral and bilateral implant pools. No patient in this

study manifested device survival beyond 21 years without the occurrence of rupture. Rupture preceded systemic disease onset in only nine patients (3%) and occurred as a single local event (i.e., without other local breast phenomena) in only four patients (1%).

TABLE 5.     Local Breast Phenomena, Category Four: Leaks or Ruptures

One hundred and forty-nine (70%) of those patients who sustained a rupture have had surgical removal with or without reimplantation. Surgical and/or pathological findings occasionally revealed dissolution of the envelope or shell, with no trace of the elastomer at the time of implant removal. At other times the envelope was noted to be fused with the capsule while on other occasions a discrete hole was detected. Rupture often appeared to be a dynamic process with creasing, cracking, or a small tear, invariably accompanied by an attempt at containment with additional fibrocollagenous connective tissue deposition around the rupture site. This clinically translated into a focal area of swelling, induration, and significant hardening as noted in the patient in Figure 9. Although closed capsulotomy has been reported to be occasionally associated with rupture (Eisenberg and Bartels, 1977; Filiberti et al., 1977), the occurrence of rupture in this series of patients with or without one or more closed capsulotomies was the same. Stated another way, closed capsulotomy was not associated with any higher occurrence of rupture compared to patients with rupture who never underwent such a procedure.

Taking into account only the 214 patients with ruptures, the average time to rupture was eight years. Rupture was not a reflection of the total number of surgical procedures. Thirty-one patients underwent removal of an initial or multiple consecutive sets of intact implants, followed by reimplantation and subsequent rupture. In all but four of the 31, the average time to nonruptured exchange was 14 months and the time to subsequent rupture 7 3/4 years. Twenty-nine patients sustained multiple ruptured sets of implants (not necessarily consecutive); in all but two cases the elapsed time to the second rupture was shorter than the elapsed time to the first rupture. Specifically, the average elapsed time for the first rupture was seven years and ten months, but the second rupture occurred over an average of four years.

FIGURE 9. Bilateral implant rupture with attempted containment, more obvious on the right where there is prominent superior swelling.

One hundred and seventeen of the 214 patients with rupture had mammography performed, and the procedure failed to detect the rupture in 64 cases (55%). Ultrasound procedures and MRI scans of the breasts proved to be more reliable but were also not infallible (as noted in prior reports) (Harper, 1985; Ahn et al, 1993; Shestak et al., 1993; Robinson Jr. et al., 1995; Beekman, 1996). Other factors adding to the delay in rupture determination included inadequate questions

of local breast phenomena, unsuspecting exams (most commonly confusing containment with capsular contracture), inadequate questions of systemic disease manifestations, patronizing attitudes ("your implants are soft"), lack of adequate follow-up, and patient denial. For those patients who underwent removal of ruptured original implants without replacement, the average elapsed time from the occurrence of rupture to surgical removal was 4 1/2 years (longest 13 years). Very often the patient had to seek out a new plastic surgeon to have this surgery done, as the patient's original plastic surgeon invariably did not consider the necessity for implant removal emergent. For those patients who underwent removal of ruptured implants followed by the simultaneous reimplantation of another breast implant, the average elapsed time from the occurrence of rupture to surgery was 15 months. Usually in this latter instance the additional surgery was performed by the patient's original plastic surgeon.

At least two distinct categories of local breast phenomena developed in 278 patients (93%), and 111 patients (37%) developed all four categories of local breast phenomena. No differences in any of the four categories were noted between the unilateral and bilateral implant groups, and neither age at the time of implantation nor the reasons for augmentation and/or reconstruction altered these analyses.

DISCUSSION

The observations in this cohort of patients clearly indicates that silicone gel-filled breast implants are capable of producing multiple local breast phenomena. These phenomena are readily detectable under ordinary clinical conditions and exhibit a chronological order to each other. With regards to capsular contracture, the average time of onset of four months is comparable to prior reports (Given and Stowens, 1991; Raso et al., 1994). No data are currently available to compare to the displacement category of this report (Table 4), but preliminary investigations by this author of another 100 patients indicate that the average appearance of this category remains constant at five years. The displacement category represents failure of the capsule, and this key clinical event was invariably the forerunner of rupture an average of three years later in all but eight of the 214 patients who developed rupture. Equally important is the report in a separate study revealing that capsular failure coincided with systemic disease acceleration at the same average interval of five years from the time of initial implantation (Brawer, 1996). These findings will hopefully offer guidance in evaluating the multiple potential mechanisms of disease causation.

Another striking finding in this cohort was the observation that the onset of systemic manifestations preceded implant rupture in all but nine patients (3%). Stated another way, implant rupture was a feature of an already established systemic disease process. Silicone gel-filled breast implant rupture has been increasingly appreciated, clearly occurs even in the absence of a silicone-induced systemic illness, and undoubtedly reflects many diverse but inevitable events (DeCamara et al., 1993; Peters et al., 1994; Shoaib et al., 1994; Netscher et al., 1995; Robinson Jr., 1995; Wolf, 1996). The available evidence appears to indicate that the rate of failure increases linearly with the duration of implantation, whereby over 50% of devices have been noted to be ruptured between ten and twenty years from the time of original insertion. The variability of reported series stems from two fundamental observations: (1) the absence of definitive tests and/or clinical examination to provide an absolute diagnosis of implant rupture; and (2) device half life is often overestimated since time to rupture is invariably less than time to removal. These problematic difficulties of rupture evaluation may be substantially reduced if more attention is paid to the local breast phenomena reflecting the preceding event of capsular failure.

It was also noted in this study that no breast implant set remained intact beyond 21 years of continuous insertion. This implies that rupture rates might be altered depending on whether or not recipients have developed a silicone-induced systemic disease process. Indeed, a circuitous situation might exist whereby the first three categories of local breast manifestations partially participate in initiating and accelerating systemic disease, and then all of these processes simultaneously contribute to an increased tendancy to rupture.

In summary, this study highlights the existence of an important integral relationship of the various local breast phenomena to each other and to the onset and progression of the patients' systemic disease process. It is anticipated that these observations will further the understanding of silicone gel-filled breast implant toxicity.

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