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5—
Reoperations and Specific Local and Perioperative Complications

Introduction

This chapter addresses the frequency of local and perioperative complications associated with breast implants. Later chapters of this report deal with long-term safety, particularly in terms of cancer and connective tissue disease. Local and perioperative complications are important outcomes in their own right, and to the extent that they lead to significant further medical interventions or impair the achievement of expected and desirable results, they are also relevant to implant safety. Five-year reoperative or secondary surgery rates or average number of implants placed per breast or per woman provide approximations of the sum of these complications. They are important to safety because, even though breast surgery is of low systemic morbidity, every operation and the attendant anesthesia carry risk. Many of the same complications that occur when implants are placed may occur when they are removed, revised, or replaced, e.g., infection, hematoma or seroma, pneumothorax, tissue necrosis (Rohrich et al., 1998a). Furthermore, other interventions such as closed capsulotomies, extra manipulations for mammographic screening or diagnosis, and medical care for rash, pain, infection and the like are often not included in reoperation and multiple replacement data and can be contributors to, or comorbidities with, the need for surgery. These other interventions can be very frequent; for example, as many as 192 closed capsulotomies in 140 patients (254 implants) have been reported (Brandt et al., 1984). Patient satisfaction, or the lack of it, is another indica-



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Page 114 5— Reoperations and Specific Local and Perioperative Complications Introduction This chapter addresses the frequency of local and perioperative complications associated with breast implants. Later chapters of this report deal with long-term safety, particularly in terms of cancer and connective tissue disease. Local and perioperative complications are important outcomes in their own right, and to the extent that they lead to significant further medical interventions or impair the achievement of expected and desirable results, they are also relevant to implant safety. Five-year reoperative or secondary surgery rates or average number of implants placed per breast or per woman provide approximations of the sum of these complications. They are important to safety because, even though breast surgery is of low systemic morbidity, every operation and the attendant anesthesia carry risk. Many of the same complications that occur when implants are placed may occur when they are removed, revised, or replaced, e.g., infection, hematoma or seroma, pneumothorax, tissue necrosis (Rohrich et al., 1998a). Furthermore, other interventions such as closed capsulotomies, extra manipulations for mammographic screening or diagnosis, and medical care for rash, pain, infection and the like are often not included in reoperation and multiple replacement data and can be contributors to, or comorbidities with, the need for surgery. These other interventions can be very frequent; for example, as many as 192 closed capsulotomies in 140 patients (254 implants) have been reported (Brandt et al., 1984). Patient satisfaction, or the lack of it, is another indica-

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Page 115 tor that can generate further interventions, as noted in Chapter 1. It should be kept in mind with respect to the following discussion that implants, surgical experience, surgical techniques, and perhaps other factors have evolved since the studies reported here were undertaken, so current experience may differ. This argues for careful prospective studies as the committee concludes at the end of this section. This chapter addresses the following topics because they have significant effects on implant safety: reoperation or secondary procedures as indicators of overall frequency of local and perioperative complications; aggregate complications in breast reconstruction; aggregate complications in breast augmentation; rupture and deflation; factors contributing to loss of implant shell integrity; detection of gel implant rupture; strength and durability of implant shells; frequency of implant rupture and deflation; description of implant fibrous tissue capsules and contractures; capsular, local breast, and distant tissue exposures to silicone and their complications; frequency of saline implant capsular contracture; barrier implants and contractures; effect of implant surface and contracture; effect of local adrenal steroids and contracture; presence of bacteria around implants, antimicrobial treatment and contracture or other complications; hematomas, their frequency and relationship to contractures; the effect of implant placement on contracture; and other relevant complications including pain. Many other local and perioperative complications in addition to those noted above require explantation or other secondary surgical or medical interventions. A reasonably complete list (see Table 5-1) would include fibrous contracture of the implant capsule; gel implant rupture (with or without migration of silicone gel outside the capsule) or saline implant deflation; filler port or implant valve malfunction; shell folds or wrinkling; infection of the surgical wound; infection around or within the implant; infection associated with toxic shock syndrome; hemorrhage and hematoma; seroma; swelling of the breast; various skin rashes and other skin manifestations such as localized morphea; epidermal proliferative reactions (Spiers et al., 1994); middermal elastolysis; edema; blistering; cysts (Copeland et al., 1993); ulceration; necrosis of the skin, nipple or mastectomy or reconstruction flap; exudation of silicone through the skin or from the nipple (Erdmann et al., 1992; Leibman et al., 1992; McKinney et al., 1987); implant extrusion, misplacement, or displacement; silicone granuloma; axillary adenopathy; sensory loss and paresthesia; pain; abnormal lactation (Hartley and Schatten, 1971; Mason, 1991) and/or galactocele (DeLoach et al., 1994; Johnson and Hanson, 1996); thoracic skeletal asymmetries (Dickson and Sharpe, 1987; Peters and McEwan, 1993); pneumothorax (Brandt et al., 1984); and calcification. "Bleed" or diffusion of small quantities of mostly lower molecular weight linear (and cyclic) silicone gel fluid compounds through the silicone elastomer shell (and to a

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Page 116 TABLE 5-1 Reported Local and Perioperative Complications Implant fibrous capsular contracture Skin rashes Gel implant rupture (intra- and extracapsular) Skin blistering, cysts, and necrosis   Swelling of the breast Gel migration Nipple or flap necrosis Silicone granuloma Implant extrusion Axillary adenopathy Implant misplacement Silicone exudation through skin or nipple Implant shifting or displacement   Acute and chronic breast and chest wall pain Saline implant deflation   Implant filler port or valve leakage Loss or change in sensation of the breast or nipple Operative wound infection   Peri-implant infection Chest wall skeletal changes Intra-implant infection Pneumothorax Infection with toxic shock syndrome Peri-implant calcification Hemorrhage at the operative site Lactation and galactocele Peri-implant hematoma or seroma   lesser extent outside the fibrous capsule) is also reported as a complication, but gel fluid diffusion is intrinsic to the design and physical characteristics of gel-containing implants (see Chapter 3 of this report). Many of these complications have been cited in the approximately 100,000 adverse event reports to the Food and Drug Administration (FDA) summarized by Brown et al. (1998). This chapter does not rely on that reporting system, however. The FDA system is sensitive to national publicity and includes voluntary reports, which frequently consist of undocumented assertions (Brown et al., 1998), and is therefore subject to distortions of the frequency and nature of implant adverse effects. Overall Frequency of Local Complications Several studies with representative cohorts of 583 to 7,008 women address the frequency of secondary interventions in saline- and gel-filled implants for both augmentation and reconstruction (Gabriel et al., 1997; McGhan Medical Corporation, 1998; Mentor Corporation, (1992). Gabriel et al. (1997) reported that 178 (23.8%) of all 749 Olmstead County women of the usual age distribution, noted in Chapter 1, who were implanted at the Mayo Clinic (95% with gel-filled implants) had clinical indications requiring reoperation ranging from explantation to drainage of a hematoma over an average 7.8-year follow-up after implantation. This amounted to 18.8% of the 1,454 breasts implanted. Multiple complications occurred in 61% of these. Although the incidence of complications requiring surgery after augmentation or reconstruction did not differ at two

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Page 117 months, by the end of the fifth year when 83% of all first complications had occurred, the percentage of patients with complications after reconstruction (30-34%) was almost threefold that after augmentation (12%). Only surgical complications were analyzed, and some that may be important, such as silent ruptures, may have been missed. The frequency of complications reported in this study is consistent with the frequencies reported in other studies cited later, especially given the long average follow-up in this series. The McGhan AR90 preliminary report (McGhan Medical Corporation, 1998) describes the 583 women of the usual age distribution who agreed to participate in this study and received McGhan 1990s, mostly textured, single- and multilumen gel-filled implants, 549 for augmentation and 34 for reconstruction, with a five-year follow-up. In this cohort, 23% of augmented women and 42.4% of reconstructed women required secondary surgery ranging from explantation to evacuation of hematoma or seroma, to correction of implant placement or contracture, to biopsy during the five-year study period. These are underestimates because implant rupture was diagnosed by physician evaluation; and therefore a number of silent ruptures were likely missed. Explantation is overestimated since about one-third (or roughly 6 and 14% of augmentation and reconstruction secondary surgeries, respectively) were at patient request because of safety concerns prevalent during the entry period (1990-1992) of this study not because of clinical indication. The McGhan large simple trial (LST) (McGhan Medical Corporation, undated) was a one-year prospective observational study of all 2,855 women of the usual age distribution who agreed to participate in this study and received McGhan 1990s, predominantly textured, room temperature vulcanized (RTV) saline-filled implants, 81.1% for augmentation. Women entered this trial in 1995 and 1996. The cumulative results after a year for four complications (infection, deflation, explant, and severe [Baker Class III or IV] capsular contracture) were 18.9 and 35.9% of women following augmentation and reconstruction (includes revisions), respectively. These figures are more reflective of actual clinical conditions since saline implant deflations are likely to be observed, and women are much less likely to have requested explantation of saline implants on nonclinical grounds. While secondary surgical frequencies were not identified as such, they are likely quite similar although probably slightly higher than the cumulative percentage for the four complications, since these complications are highly predictive of surgical intervention. Additional complications in this cohort will occur in the one- to five-year interval. Comparison of these results with overall complications of the previously cited AR90, long follow-up gel-filled implants is inappropriate. Women receiving Mentor gel-filled implants (and some receiving ex-

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Page 118 panders) were enrolled in the company's adjunct study. At the three-year follow-up, there were 3,559 women with reconstructions and 3,449 women with augmentation, almost all with low-bleed, gel-filled implants. The overall frequency of infection was 2.8-4.3% in reconstructions and 1.3% in augmentations. The overall Class III-IV contracture prevalence was 12-13% in reconstructions and 11% in augmentations. The overall frequency of rupture was 1.3-1.7% in reconstructions and 0.7% in augmentations—but these ruptures were determined by physical examination only (Purkait, Mentor Corporation., IOM Scientific Workshop, 1998). In addition to these studies, Gutowski et al. (1997) reported the outcomes of 504 patients with 995 predominantly Heyer-Schulte-Mentor saline implants in an 11-center retrospective cohort study. These patients represented the 41.5% of those identified by the plastic surgery centers that were successfully interviewed, but it is not clear how patients were identified or what proportions of the total number of women with implants at the centers were identified. This uncontrolled accession of patients raises significant concerns about the interpretation of any results. Implants were placed almost entirely (93.8%) for augmentation, evenly divided between submuscular and submammary positioning in 1980-1989, and were followed for an average of six years. Of these women, 20.8% underwent secondary surgery, primarily for replacement, removal, or capsulotomy. The complications of infection (0.2%), hematoma (1.6%), and seroma (0.1%) were infrequent. Deflation occurred in 55 implants (5.5%) and 51 women (10.1%). Deflation (and rupture) frequency differed by implant model. Only about 4.2% of the predominant late model RTV implants deflated. These probably represent minimum figures (Gutowski et al., 1997). Fiala et al., (1993) reported the results of a survey of 106 women representing 62.9% of a cohort of 167 women who could be located from the original 304 women who had undergone breast augmentation from 1973-1991. Their implants were primarily smooth silicone gel (70.8%) but also included some polyurethane-coated (27.1%) and a few textured implants. In this survey, 73.9% of women reported being ''highly satisfied," 19.8% of women underwent secondary surgery, and the complications were mostly contractures. Contractures occurred more often as time progressed and significantly more in submammary than submuscular implants. There were fewer contractures, though not statistically significantly, around the polyurethane compared to the smooth implants (Fiala et al., 1993). Edworthy et al. (1998), surveying the experience of a population of 1,112 unselected women with silicone gel-filled implants, found that 214 women (19.25%) had undergone secondary surgical procedures and 38.5% of breasts implanted (average of frequencies reported for left and right breasts) had Class III-IV contractures. The odds of a woman

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Page 119 needing more than one implant per breast over time are high, and placement of as many as 16 implants per woman has been reported (Roberts et al., 1997). In one small cohort of 52 mostly (67%) augmented women who agreed to participate in the study, out of 138 consecutive women with breast implant problems, the average was 3.19 gel implants per woman over an average of 11.9 years (Wells et al., 1995). In another small cohort (N = 60) of consecutive women undergoing immediate reconstruction with expanders, 2.78 operations were required on average for each woman, 0.78 for complications and 2.00 for original expander insertion and the following permanent implant replacement (Slavin and Colen, 1990). Shanklin and Smalley (1998a) reported 3.45 implants per women in a small experience (N = 130) with patients self-selected for problems and a 49.3% frequency of procedures in addition to implant replacement including 15.4% closed capsulotomies. Although the data were reported in a way that made it difficult to aggregate them, each woman appeared to have undergone 1.8 to 1.9 operations, many of which were on the normal breast for correction of asymmetry in the series of 109 women with delayed postmastectomy reconstructions reported by Houpt et al. (1988). Worseg et al. (1995) reported 83 secondary operations in a cohort of 77 women implanted with inflatable (saline or dextran) Heyer-Schulte-Mentor implants with a mean follow-up of nine years. There was an average of 1.08 secondary operations per woman, predominantly for deflation (23.9%) or severe contracture (37.6%). Similarly, Middleton (1998b) reported a series of 1,251 women seen since 1992 at the University of California at San Diego with a diverse array of implants who were referred for magnetic resonance scans because of suspected implant problems. He found that 15.35, 30.56 and 45.19% of these women required replacement implants within five years following augmentation, cancer mastectomy, and prophylactic mastectomy, respectively. This population, which was referred for problems, averaged 1.54 implants per breast (Middleton, 1998b). These studies covered different follow-up periods, different kinds of implants, and different indications for implantation. Some were surveys, some record reviews, and some prospective observational trials. Each group was of unknown relation to the total group from which it was selected with respect to the events being studied. The results, therefore, cannot be compared scientifically. Although a quantative estimate is not possible, it appears that a significant number of women can expect additional procedures in the first five years after implantation. Women with implants for reconstruction and with gel-filled implants appear more likely to be at the upper end of the range of frequency.

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Page 120 Breast Reconstruction After Mastectomy Perioperative and local complications are significant medical and patient events. Some complications are procedure related, that is, they would occur independent of the presence of an implant, and some are implant dependent and may vary with the characteristics of the implant, as noted in Chapter 3. This is particularly clear in reports that compare perioperative complications in reconstructions after mastectomy with matched mastectomy patients without reconstruction, in a sense "operative controls." O'Brien et al. (1993) in a short follow-up study, reported a similar complication frequency of 28% (N = 82) in 289 mastectomized women who were not reconstructed, compared with 31% (N = 35) in 113 women who were reconstructed, primarily with subpectoral expanders, after mastectomy. Most perioperative complications were the same, but seromas requiring one or more aspirations were present in 19% (N = 55) of those without reconstruction and only 3% (N = 3) of those with reconstruction. Implant-related problems occurred in 14% (N = 16) of the reconstructed women, including eight who required explantation (O'Brien et al., 1993). Vinton et al. (1990) in a study primarily about immediate, surgical complications, reported a similar total complication rate of 48% in 305 women undergoing modified radical mastectomy without reconstruction and 37% in 90 women with mastectomy and immediate reconstruction, primarily with expanders. Again, seromas were more frequent in the nonreconstructed group (30% versus 13%), and the reconstructed group had a 6% prosthesis complication rate with 4% requiring explantation (Vinton et al., 1990). With respect to total short-term complications in reconstruction, these reports suggest that the implant may prevent seromas. Other complications such as infection, hematoma, and epidermolysis or skin necrosis occur with about equal frequency in women undergoing mastectomy who have implants and those who do not. The frequencies of early complications in implanted and nonimplanted women after mastectomy are roughly equal in these reports, but implant related complications are underestimated because of the short follow-up. Comparisons such as these are not possible in augmented patients because there can be no operative controls. In reconstruction after mastectomy, surgery is a precondition and the avoidable risk is only the implant-dependent fraction; in augmentation, surgery is not a precondition, and the risks of silicone implants may not be as separable from the operative risks. Implant technology designed to minimize risk is important in both instances. Similar results are reported from case series of implant patients. Noone et al. (1985) reported on 85 women undergoing immediate reconstruction after mastectomy with saline and double-lumen implants with

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Page 121 short follow-up and the usual complications of skin necrosis (15%), seroma or hematoma (12%), extrusion (4%), infection (2%), and severe contracture (11%)—or 44% overall—15% of which (contracture, extrusion) were clearly implant dependent. In addition, secondary surgery later was required for open capsulotomy and explantation in 14.4%. Francel et al. (1993) reported 57% revision surgeries with permanent saline implants or expanders in immediate reconstruction after mastectomy and 30% in delayed reconstruction, with minor complication frequencies of 8.1 and 14% respectively, and implantation failures of 3.5% in both groups. Eberlein et al. (1993) reported 19 (27%) secondary surgical procedures (replacement or capsulotomy) and 8% prosthetic loss in 71 women with submuscular double-lumen implants after mastectomy, and Bailey et al. (1989) reported 18% implant loss in 165 women reconstructed with submuscular expanders or gel implants. Crespo et al. (1994) reported 115 consecutive implant reconstructions at the time of mastectomy using McGhan double-lumen smooth implants. Secondary surgery was performed in 20% of these women, and there were 5% infections, 8% explantations, 11% seroma or hematomas and 3% tissue flap necroses (Crespo et al., 1994). Gylbert et al. (1990a) reported breast reconstruction in 65 women with randomly selected gel or saline implants followed for an average of six years: 6 of 37 (16%) patients with saline implants required replacements because of deflations, and three other operations were needed for misplacement, severe contracture and extrusion (8%). This study was primarily of contracture and is reviewed again later in this chapter. Using expanders and gel implants for immediate and delayed reconstruction, Slavin and Colen (1990) had an overall complication rate of 60% (among them, 15% seromas, 13.3% skin necrosis, 8.8% extrusion, 6.7% infection) in 60 consecutive immediate reconstructions involving expanders. Kroll and Baldwin (1992) had 23% "failures" (poor aesthetics or failure to complete reconstruction) at 22 months' follow-up in 87 women reconstructed immediately with expanders, followed by permanent replacement with polyurethane or other gel-filled implants. Schlenker et al. (1978) studied 89 women with immediate or delayed reconstruction after simple mastectomy for fibrocystic disease over 6 months to 12 years. They removed implants in 28% of these patients for infection, extrusion or necrosis. Using primarily the Mentor 1600 inflatable saline implant, Schuster and Lavine (1988) reported 98 women undergoing immediate submuscular reconstruction after subcutaneous prophylactic mastectomy over a nine-year period. Eighteen patients suffered tissue loss, and there were three extrusions, among a number of less troublesome complications (Schuster and Lavine, 1988). In a study of wound complications in implant or expander immediate breast recon-

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Page 122 structions in 112 women, Furey et al. (1994) observed complications in 25 patients (22.3%) and removed 8 implants; other complications were not reported. Camilleri et al. (1996) reported 111 consecutive women reconstructed using the Becker (reverse double-lumen, gel outside) permanent expander with an average follow-up of only one year. Complications more typical of expanders, such as wound dehiscence (8%) and filling port failure (6%), occurred in addition to contracture (9%), expander infection and removal (5%), skin flap necrosis and expander exposure (5%), and other sequelae such as pain on expansion (20%). Despite these complications, 89% of women expressed satisfaction to the plastic surgeon on follow-up (Camilleri et al., 1996). Gibney (1987) using CUI or Heyer-Schulte expanders for reconstruction in 65 women with three to seven years of patient follow-up, reported 5.8% of breasts with contractures, 2.5% with infections, and 4.5% with deflations, resulting in loss of the implant in 4.6%. Mandrekas et al. (1995) compared 19 women with immediate to 25 women with delayed reconstruction using subpectoral smooth tissue expanders after cancer mastectomy. The longest follow-up was seven years, but most complications were assessed by one year. These included one seroma, one infection, one skin necrosis, one valve deflation, ten Class II-IV contractures and two malpositions—16 complications in 15 (34%) women, more frequent in delayed reconstruction. There were no rheumatic complaints (Mandrekas et al., 1995). Mahdi et al. (1998) carried out a prospective trial using the McGhan reverse double-lumen expander in 16 immediate and 4 delayed subpectoral reconstructions followed for an average of 10.1 months. There were seven reoperations for correction of placement, one hematoma, and two filler port problems. Follow-up was insufficient to evaluate rupture or contracture (Mahdi et al., 1998). Spear et al. (1991) reported 76 women with 89 double-lumen implants for immediate reconstruction, randomized to 16 mg methylprednisolone in the outer saline lumen or to controls. Except for a lower frequency of contracture in the steroid group, the two groups were comparable three years after implantation. There were a total of 38 operative revisions, 2 significant infections, 3 extrusions, 16 fluid collections, 6 instances of skin necrosis and 26 Class II-IV contractures. Spear and Majidian (1998) subsequently reported 171 immediate postcancer mastectomy reconstructions with textured McGhan expanders in 142 women. Expanders were mostly replaced by textured saline implants, and follow-up after completion of reconstruction averaged 19 months. There were 14 (8.1%) skin necroses, 2 (1%) hematomas, 6 (3.5%) infections, 8 expanders and 11 implants (6.4%) requiring replacement and 5 (3%) significant capsular contractures. Equal or better results using textured expanders were reported by Fisher et al. (1991; see also Maxwell and Falcone, 1992; Russel et al., 1990; Beasley,

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Page 123 1992 who reported infrequent loss of expanders and rare contractures). In a review of a large experience with saline expanders (currently the most widely used technology for reconstruction according to the 1997 American Society of Plastic and Reconstructive Surgeons [ASPRS] survey), Woods and Mangan (1992) implied that results at the low end of reported complications could be achieved through experience and care. As earlier, these studies include a number of variables. However, based on these reports, it appears that women, historically, could expect early (postoperative) complications, up to 30%-40% after reconstruction with implants, because reconstruction typically involves a significant surgical procedure to begin with (i.e., mastectomy for breast cancer). In addition to the surgical complications from mastectomy and implantation, there are the usual complications that depend on the presence of the implant. Breast Augmentation Using Mentor implants for submammary augmentation, with a follow-up of four or more years for 87%, Capozzi (1986) reported 3.4% of breasts with contractures, 3.4% with deflations at intervals from nine months to seven years, and 100% satisfaction in 100 women between 1976 and 1985. Cocke (1994), using Heyer-Schulte-Mentor saline implants in 75 women for augmentation, mostly submammary, followed for 1.5 to 13 years, reported 29% (N = 22) secondary surgeries and 52% (N = 39) complications (23 contractures requiring treatment). McKinney and Tresley (1983) reported a series of 58 Women using Heyer-Schulte saline implants in the submammary position, with a number of complications including deflation (N = 9), infection (N = 4), capsules (N = 14), and hematomas (N = 9). In a letter report, Bell reported 10 deflations on average at 32 months of the same implant model in a series of 193 women (Bell, 1983). Others have reported very infrequent failures. Mladick (1993) summarized results from his experience with saline augmentation over 17 years in 1,327 women with 9.1% secondary surgery. Most of these implants were modem RTV saline inflatables, but high termperature vulcanized (HTV) saline implants had been used earlier. Although the average follow-up was short, only 28 months, as is often the case, the deflations of the older implant models were 37.7% compared to the 1.33% for the more recent model, and complications were infrequent, mainly contractures in 1.1% of breasts, and no infections (Mladick, 1993). Frequent deflations (5-8%) were reported with the early saline models by others (Grossman, 1973; Regnault et al., 1972). Lavine (1993) reported placing 2,018 saline implants, with 4.2% of patients needing revisions, 1.1% Class III-IV contractures, and 2.3% deflations of all implants, but only 0.56% deflations of recent model Heyer-Schulte inflatables. The follow-up of these implants

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Page 124 ranged from 6 months to 13 years (Lavine, 1993). These reports also include a number of different variables, but they generally find a lower complication frequency, more consistent with the overall reoperation frequencies cited earlier, which were based mostly on results of women with implants for augmentation. Specific Complications The important events for the safety of breast implantation are those that require significant interventions and seriously detract from the desired cosmetic objective. These include gel implant rupture (especially extracapsular) or saline implant deflation, severe contracture, infection, significant hematoma, severe and continuing pain, granuloma and axillary adenopathy, and implant displacement and extrusion. These are events that may require surgical revision, extensive medical or surgical attention or explantation, or leave the patient with deformity and discomfort. The occurrence of individual local and perioperative complications varies enormously among reports. Differences in complication frequency result from multiple factors: (1) individual unexplained variability in biological reaction to the device (e.g., fibrous capsular contractures); (2) differences in women's ages, physical conditions, habits, comorbidities and indications for implantation; (3) differences in types of implants and their physical and chemical characteristics, as described below and in Chapter 3; (4) differences in the design, adequacy, and reporting of clinical and basic research that may distort the true biological and medical picture; and (5) variable techniques and skills of surgeons and other medical personnel (e.g., operative techniques and skill and/or coincident medical interventions such as antibiotics, antiseptics, closed capsulotomies, steroids, treatment for cancer, and others). In the discussions that follow, evidence for the contributions of these factors to a particular complication or the frequency of complications is reviewed. In some instances, a role is likely but speculative. In other instances, there are data to support objective statements, at least of limited or suggestive evidence of an association. Although a great deal has been learned, much more work on biologic variation is needed to fully understand the influences of this factor. As noted earlier, there are differences in the frequency of complications in women who receive implants for augmentation and for reconstructions and in those with immediate and delayed reconstructions. Although age may not influence most complications, the amount of body tissue and fat available for implant coverage, habits such as smoking or alcohol abuse (which could affect tissue viability), and significant medical illness (diabetes) are reported to make a difference (Cohen et al., 1992). Implant types and characteristics are im-

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Page 168 wounds or infecting implants perioperatively, such as Staphylococcus aureus b hemolytic streptococci, or less virulent staphylococcal species. A diverse array of bacteria can be cultured from the surface of, or from breast tissue around, implants often with no clinical signs, such as S. epidermidis and related species, Propionibacterium acnes and related species, S. aureus, anaerobic diphtheroids and more rarely Streptococcus A and B, Escherichia coli, Enterococcus, Corynebacterium, Klebsiella, Pseudomonas and infrequently others (Ablaza and LaTrenta, 1998; Ahn et al., 1996; Brand, 1993; Clegg et al., 1983a; Coady et al., 1995; Courtiss et al., 1979; Dobke et al., 1995; Foster et al., 1978; Gylbert et al., 1990b; Hunter et al., 1996; Lee et al., 1995; Netscher et al., 1995b; Peters et al., 1997; Truppman et al., 1979; Virden et al., 1992; Williams et al., 1982; Young et al., 1995a). Some of these latter organisms, and occasionally fungi, may also be found within saline expanders and inflatable implants, where they can survive and even proliferate possibly supported by glucose that diffuses into, and has been measured within, the implant (Blais, IOM Scientific Workshop, 1998; Chen et al., 1996; Coady et al., 1995; Nordström et al., 1988; Young et al., 1997). Presumably they enter through the punctures in the inflation ports (Liang et al., 1993). These periprosthetic organisms are usually discovered on aerobic and anaerobic culture of implants, pockets and capsules. They are often not involved in clinically apparent perioperative infection problems, which for the most part are caused by S. aureus, hemolytic streptococci or some less virulent staphylococci, are infrequent, and occur within a month after surgery (Courtiss et al., 1979). In general, studies of infection suffer from the use of varying culture technologies, some failing to culture anaerobically or for a long enough time, some with greater or lesser vigor and thoroughness in sampling the implant surface or peri-implant tissue (Virden et al., 1992). Local, perioperative infections are generally treated with antibiotics and resolve, although they may contribute to pain or other complications. The frequency of these infections is reported in many case series and ranges around 1-4% after augmentation and significantly higher after reconstruction (e.g., 13%, Bailey et al., 1989; 6%, Courtiss et al., 1979; 5%, Crespo et al., 1994; 7%, Eberlein et al., 1993; 5.8%, Furey et al., 1994; 2.5%, Gibney, 1987; 2%, Noone et al., 1985; 3%, O'Brien et al., 1993; 5%, Slade, 1984; 13%, Vinton et al., 1990) including one report of very high numbers of infections, 8 of 15 patients (53%), in women undergoing immediate postmastectomy reconstruction with expanders (Armstrong et al., 1989). Gabriel et al. (1997) reported a combined total of 1.1% of breasts, implanted primarily for augmentation, reoperated for infection. Brandt et al. (1984) reported 3.9% infections in gel augmented breasts. Biggs et al. (1982) reviewing an 18-year experience reported 2-7.6% of patients reop-

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Page 169 erated for removal of infected implants at various stages in the evolution of this practice (Biggs et al., 1982). The McGhan LST found 1.1 and 6.9% of breasts with infections after saline augmentation and reconstruction, respectively, and the McGhan AR90 (1998) five-year experience of infection with gel implants was 0.7% of augmented breasts and 0% of reconstructed breasts. The Mentor adjunct study (1992) found 4.3 and 1.3% infections at the three-year follow-up of gel implantation for reconstruction and augmentation, respectively. Very infrequent infections in saline implant augmentation were reported by Gutowski et al. (1997), 0.2%; and by Mladick (1993), 0%. A frequency of infections in mostly inflatable saline implant augmentations of 1.5% was reported by Rheingold et al. (1994). A survey by Brand of 73 plastic surgeons using a diversity of implants found frequencies of infection of 0.06-0.16% for implants in augmentations and 0.3-6% for implants in reconstructions. Since a long time interval was covered and "only severe infections" were reported, considerable underreporting is probable in this survey (Brand, 1993). In a Centers for Disease Control and Prevention (CDC) survey of 2,734 plastic surgeons with a 67% response rate, wound infection after augmentation was reported in 0.64% of patients (Clegg et al., 1983b). Some wound infections are not treated successfully with antimicrobial therapy and result in loss of the implant (Courtiss et al., 1979). Very rarely, there are very serious or lethal complications such as staphylococcal, streptococcal, or other bacterial toxic shock syndrome (Barnett et al., 1983; Bartlett et al., 1982; Brown et al., 1997a; Giesecke and Arnander, 1986; Holm and Muhlbauer, 1998; Oleson et al., 1991; Poblete et al., 1995; Tobin et al., 1987; see also Walker et al., 1997, for a case after explantation and granuloma excision). Very rarely also, an infection may occur in an otherwise well-tolerated implant many years after surgery without an apparent inciting event (Ablaza and LaTrenta, 1998). In addition there is evidence that infection is associated with increased frequency and severity of implant capsular contracture and thus with the interventions that accompany this complication. The tissue of the breast is open to the environment through the lactiferous ducts, which are colonized extensively by normal skin flora, both aerobic and anaerobic bacteria, primarily S. epidermidis, P. acnes and anaerobic diphtheroids. As a result, bacteria can be recovered from 91.6% of female breasts, usually bilaterally (primarily coagulase-negative staphylococcal and propionibacterial species, Ransjö et al., 1985). Implants themselves, implant pockets, or capsules and nipple secretions have yielded 23.5-89% positive bacterial cultures, using various techniques (Ahn et al., 1996; Burkhardt et al., 1981; Courtiss et al., 1979; Dobke et al., 1995; Gylbert et al., 1990b; Netscher et al., 1995b; Peters et al., 1997; Thornton et al., 1988; Virden et al., 1992).

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Page 170 These bacteria, particularly gram positive bacteria, have been shown in vitro to be able to adhere within two minutes to, and colonize, all types of silicone breast implants (Jennings et al., 1991a,b; Sanger et al., 1989). They are often located in a bioslime film on the surface of the implant (Dougherty, 1988), where they are largely protected from antibiotic action (Evans, 1987), and they presumably contribute to infections after implant surgery. Thornton et al. (1988) found that some postoperative breast infections were associated with the same organisms that they had cultured at the time of surgery (both for implantation and for breast reduction) from deep within the breast, primarily coagulase negative staphylococci. In this series of 30 patients (19 with breast reductions), contracture was associated with positive cultures, but the numbers were too small to achieve statistical significance (Thornton et al., 1988). In rabbits with implants contaminated with S. epidermidis compared to sterile controls, the contaminated capsules were Class III-IV and two to three times thicker with more dense collagen than the control Class I-II capsules (Shah et al., 1981). In a subsequent study, the effect of intraluminal cephalosporin was evaluated in this protocol, and the thickness of the capsules around contaminated, antibiotic-containing implants was significantly reduced (Shah et al., 1982). At about this time, cephalosporin (and gentamycin) had been found to diffuse from Heyer-Schulte saline implants in significant concentrations for up to six months (Burkhardt et al., 1981). Guinea pigs formed capsules more rapidly after experimental implants were dipped in staphylococcal broth cultures overnight (Kossovsky et al., 1984). Quantitative data in this report were sparse, and the effect of coating an implant with broth before placement may be an uncontrolled, confounding variable. Others have experimented with iodinated silicone implants. Implants containing povidone-iodine (Betadine) were found to inhibit bacterial growth in vitro due to the diffusion of free iodine through the shell. Saline implants placed in mouse tissue pockets contaminated with S. aureus had capsules 2.8 times thicker than povidone-iodine implants similarly placed or saline implants placed in sterile pockets (Birnbaum et al., 1982; Morain and Vistnes, 1977). Since iodine degrades the silicone shell, this is not a clinically useful observation (Morain, 1982). Broadbent and Woolf (1967); Burkhardt et al. (1986); Courtiss et al., (1979); and Dobke et al. (1995) reported clinical associations of positive cultures with contracture, and Netscher et al. (1995) found a significant association of Class IV contractures with positive periprosthetic explant capsule cultures. Virden et al. (1992) performed routine and special research cultures with 55 silicone implants (38 gel- or saline-filled implants and 17 expanders) removed from 40 women. Class III-IV contracture was observed around 24 (63%) implants and 3 (18%) expanders, and cultures

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Page 171 (mostly research not routine) were positive (primarily S. epidermidis) from 56% (15 of 27) of implants with contractures and only 18% (5 of 28) of implants without contracture, a statistically significant (p < .05) difference. Similar to the findings of Parsons, 91% of painful contractures were associated with positive cultures (Virden et al., 1992). Burkhardt et al. (1981) originally noted a decrease in Class III-IV contractures to 3% of breasts with implant intraluminal Keflin or Garamycin in a short follow-up study, compared to a historical control rate of 37%. They subsequently conducted a prospective randomized trial using single-lumen saline inflatable implants in the submammary position that compared a control group with four groups using a variety of antibacterial treatments, including local irrigation with povidone-iodine, antibiotic foam, and intraluminal cephalothin. They demonstrated a significant improvement in Class III-IV contracture from a control value of 41% to a combined experimental group value of 19% (Burkhardt et al., 1986). In a subsequent prospective, randomized study that looked at both texturing and povidone-iodine, the antibacterial irrigation failed to have any effect on contracture (Burkhardt and Demas, 1994), and Gylbert et al. (1990b) could show no effect on contracture of preoperative infusions of antibiotics that dramatically lowered the culture positivity of the implant pocket. This latter result is consistent with the generally held conclusion that preoperative prophylactic antibiotics are of little value (Courtiss et al., 1979) and may also reflect the fact that subclinical implant infections in a slime layer around the implant are protected from antibiotic action (Virden et al., 1992). Gutowski et al. (1997), however, reported that implants containing antibiotics experienced a lower frequency of contracture and in a final prospective randomized study that compared implant texturing from another manufacturer and povidone-iodine irrigation of the implant pocket with untreated smooth implants, a significant effect of antibacterial treatment on Class III-IV contracture was observed (Burkhardt and Eades, 1995). Dobke et al. (1995) in culturing a series of 150 explanted gel and saline (19 implants, 26% culture positive) breast implants, noted that 76% (62 out of 82) of those with Class III-IV contractures, but only 28% (19 of 68) of those without contracture were culture positive, primarily with S. epidermidis. This difference was statistically significant (p < .05) (Dobke et al., 1995). According to Burkhardt, (1988) infection explains the varying occurrence of contracture, that is, its frequent appearance unilaterally as well as bilaterally in proportions that statistically appear to represent a random (infectious) event. More recently, Peters et al. (1997) reported no association of capsular culture positivity (of 42%) with severe contracture in a series of 100 women whose implants were removed. Dowden (1994) suggested that the presence of the subclinical infec-

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Page 172 tions or contaminations described above may contribute to systemic signs and symptoms such as fatigue, myalgia, diarrhea, and arthralgia, among others, in implanted women. He reported seven women, five of whom had positive cultures for S. epidermidis or Propionibacterium acnes, whose symptoms resolved and whose health returned soon after explantation (Dowden, 1994). In a study that compared women with implants without general health problems to women with implants and a similar, but somewhat more extensive constellation of signs and symptoms, including arthralgia, dry mucous membranes, fever, hair loss, and cognitive problems, Dobke et al. (1995) found health problems to be associated with positive cultures. Among women with these symptoms, implants were 81% culture positive compared to 28% positivity in those without such signs and symptoms, and among women with both the three systemic signs and symptoms and Class III-IV contracture, 95% (19 of 20) of patients had culture-positive implants. Earlier, the same group had tested the hypothesis that a painful pros-thesis signified subclinical infection. Painful breast and penile prostheses were cultured at explantation and compared with cultured expanders (removed for replacement with a permanent implant) or with cultures of malfunctioning penile implants. In the aggregate 26 out of 28 (93%) painful prostheses and 4 out of 31 (13%) devices that were not painful were infected, mostly (> 90%) with S. epidermidis. Replacement of infected and painful devices with sterile devices while giving antibiotics resulted in pain-free devices in nine of ten instances (Parsons et al., 1993). Others evaluating culture-positive explants have not found associations with the health problems noted above, although little in the way of description is provided (Ahn et al., 1996), and the evidence for an effect of infection on symptoms remains limited. Also, the important data of Burkhardt would be more persuasive if the comparison control groups of smooth saline implants were not at the upper ends (27-41%) of the Class III-IV contracture rates for modern saline implants, and some studies have been negative (e.g., Peters et al., 1997). The differences in contracture frequency with saline versus gel and textured versus smooth implants are not readily explained by a bacterial theory of causation. Nevertheless, the evidence for a relationship between the presence of bacteria around the implant and contracture, although not conclusive, is certainly suggestive. Role of Hematoma Collection of blood, hematoma, or tissue fluids, (seroma), around implants is very like overt infection in that it complicates a small number of implantations, often requires an invasive intervention, although some

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Page 173 resolve (or drain) spontaneously, and has been suggested as a factor in contracture. Since the frequency of clinically apparent hematoma or seroma is usually much lower than that of significant contracture, this complication is, at the most, a small contributor to contracture. Hematoma was the indication for reoperation in 3.5% of the breasts in the Mayo Clinic series (Gabriel et al., 1997). In the experience of one plastic surgery clinic 5-10.3% of patients were reoperated for hematoma over an 18-year period (Biggs et al., 1982). Hematoma or seroma was not reported in the McGhan LST or AR90 observational studies. This complication probably is reported quite variably, and often it is mentioned in case series reports only in a cursory fashion, if at all. Some of these reports of hematoma or seroma frequencies and the instances of accompanying operative interventions to provide open or needle drainage have been noted earlier in this report. Plastic surgeons vary in the use of drains (which some report prevent contracture to a meaningful extent—Brandt et al., 1984; Hipps et al., 1978) and other operative precautions to prevent or manage bleeding and the collection of blood around implants. Many surgeons use drains when implanting textured-surface implants to prevent seroma formation. Also, hematomas around implants may become infected or be associated with infections (Courtiss et al., 1979). A hematoma frequency of 2%, most requiring reoperation, was reported by Rheingold et al. (1994) and Baker et al. (1975). Additional reports include 1.4% hematoma (Biggs et al., 1990), 5.9% (Brandt et al., 1984), 4.5% with implant loss (Artz et al., 1991), 0% hematoma or seroma (Bayet et al., 1991), 6% hematoma (Capozzi, 1986), 20% ''postoperative bleeding" (Gylbert et al., 1989), 1.1% hematoma (Lavine, 1993), 0.48% of hematomas (Mladick, 1993), 2.1% hematomas (Williams, 1972) and so on, for augmentation and reconstruction with both gel and saline implants. These reports are typical for hematomas that are observed within days after implantation. Rarely hematomas occur years later in association with contracture, due presumably to microfractures of the stiff fibrous capsule. These can pose significant problems requiring more extensive surgery (Cederna, 1995; Frankel et al., 1994; Marques et al., 1992). Conversely, there are those who believe that events such as trauma, which could produce hematoma, may cause late-onset contracture (Ashbell, 1980). Observations of hematoma associated with contracture are mixed. Some report the absence of an association (Asplund, 1984; Coleman et al., 1991; Hakelius and Ohlsen, 1992), but these reports involve very small numbers of hematomas and were not designed to study the issue. Others have found a significant association between hematoma and contracture in their clinical studies (up to two- or threefold greater prevalence of contracture in implants with hematoma than in those without (Handel et al., 1995; Hipps et al., 1978; Wagner et al., 1977; Watson, 1976). In a study

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Page 174 involving baboons, with numbers too small to have any significance, implants with blood around them had thicker and harder capsules. In another larger study with rats, hematoma had no effect on either capsular thickness or intraimplant pressure, although a combination of hematoma and steroid did elevate pressures (Moucharafieh and Wray, 1977). Caffee (1986b) also found no effect of hematoma on capsular contracture in rabbits. These studies are inconclusive. The safety implications of hematoma involve primarily the few percent extra interventions required to resolve these complications, the suggested association of infection, and the limited evidence that the incidence of contracture and its accompanying problems might be somewhat higher around implants with hematomas. The Influence of Implant Location The placement of implants in the submuscular position, which was originally reported by Dempsey and Latham (1968) and modified to partial muscular coverage by Regnault and colleagues has a salutary influence on the incidence of contracture, decreasing it in the latter report from 30% in the submammary group to 10% in the submuscular group (Regnault, 1977; Regnault et al., 1972). This effect is reported in a number of additional studies that cite significant decreases in contracture when comparing women with submuscular implants to women with submammary implantation of different kinds of gel-filled implants. These include decreases from 11.1% to 3% of Class III-IV contractures with some standard and some low-bleed gel implants (Biggs and Yarish, 1990); 40% to 5% of patients with severe contracture (Mahler and Hauben, 1981); 83.8% to 27.1% of Class III-IV breasts with gel implants of 12 years' duration or less (Peters et al., 1997); 41% to 8% of Class III-IV contractures with gel-filled implants (Puckett et al., 1987); improvement from 30% Class I contracture to 95% Class I contracture around gel-filled implants (Scully, 1981); average self-assessed Baker score at five years of 2.9, submammary to 2.1, submuscular using gel-filled implants (Fiala et al., 1993), and 58% submammary and 9.4% submuscular gel implant contractures (Vasquez et al., 1987). Other reports, cited earlier, describe low rates of contracture in patients with submuscular implants studied and reported for other reasons (e.g., Chang et al., 1992). A review of the literature by Puckett, cited in another report, concluded that Class III-IV contractures occurred in 43% of breasts with submammary and 6% of breasts with submuscular implants (Biggs and Yarish, 1988). Hetter (1991) repeated his 1979 survey and reported that the contracture (firmess) rate had dropped from 64% to 8% since he had changed from the submammary to the submuscular approach. In a study of saline inflatables, Cocke reported 44% noticeable

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Page 175 firmness in submammary implants and 19% in submuscular implants (Cocke, 1994). In a review of a large experience with polyurethane-coated gel implants, 22 of 658 (3.3%) implants in the submuscular position had Class II-III contractures (only two were Class III) compared to 14 of 237 (5.9%) submammary placements with Class II contractures (Hester et al., 1988). A few studies compared contractures after subcutaneous implantation with those after submuscular implantation of gel-filled breast implants. Two found firmness of 31-50% in submuscular and 80-100% in subcutaneous implantation (Slade, 1984; Ringberg, 1990). A third study found 0 and 7% of breasts with Class IV and Class III contractures, respectively, in submuscular (includes both pectoral and serratus coverage), and 7 and 33% of breasts with Class IV and Class III contractures, respectively, in subcutaneous implantation in delayed reconstruction followed from one to five years (Gruber et al., 1981). There appears to be sufficient evidence to conclude that submuscular rather than subglandular or subcutaneous placement of the implant is associated with a lower incidence of severe contracture. This observation should be among the several factors considered by both the patient and surgeon in deciding between submuscular and other placement of the implant. Not everyone agrees with a policy of routine placement of implants under the muscles of the chest wall for augmentation (Ashbell, 1980; Courtiss et al., 1974), and plastic surgeons still use the submammary approach in 32% of augmentations (ASPRS, 1997) presumably because of the better aesthetics of this placement in breasts with adequate tissue cover, and possibly because submuscular implantation has been associated with more pain. Placement has relevance for the issue of safety primarily because of its effect on contracture, which lessens the need for interventions secondary to this complication. The submuscular position may also facilitate examination of the breast for cancer, since the glandular tissue lies above the implant and is all available for palpation (Little et al., 1981, see also Chapter 12 ). Although the submuscular operative approach is technically somewhat more demanding, the rates of rupture, deflation, infection, hematoma, and other complications do not seem to differ significantly between submuscular and submammary placement. Occasional speculation about the submuscular position, noted below, does not have convincing nonanecdotal, experimental, or clinical support in the studies cited. It cannot be concluded that submuscular implants, being further away from potentially contaminated breast glandular and ductal tissue, are less prone to infection. There is no evidence that such implants are in some way less sensitive to silicone droplets, or might benefit from the massaging action of overlying musculature. Although the theory is intuitively attractive, there are no data in the literature avail-

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Page 176 able to the committee to show that placement of implants with muscular cover between them and glandular tissue results in earlier diagnosis c)f breast cancer by palpation or mammography, or that contracture might not be less frequent but merely more difficult to detect in this position. Other Complications and Their Relevance to Safety At the beginning of this chapter, local and perioperative complications were discussed. Not all of these have numerically significant, or medically and clinically important, safety implications. Although some of these conditions may be mentioned in other chapters of this report, the committee finds that for its purposes here the major influences on safety have been discussed. For example, although the reference list includes about 30 citations on the effects of radiation therapy in women with breast implants, implants themselves have good stability to clinically relevant dose levels of irradiation, they do not significantly interfere with the radiation beam and radiation therapy, and evidence that radiation can increase implant capsular contracture is limited (see Chapter 3 for discussion). One additional problem may merit some attention. Pain associated with implantation is common enough to be considered. Localized pain results in requests for implant removal (e.g., as an indication in 19.2% of explants, Beekman, 1997b, as one of the major reasons for a 13% prevalence of replacement, Bright et al., 1993) or in interventions for relieving pain associated with contracture. Some authors have reported complaints of pain in the great majority of women with implants (107 of 114 consecutive patients, Silver and Silverman, 1996), pain manifesting as a new "chest wall syndrome" in 68% of women with implants (Silver et al., 1994), or pain in 36% of women explanted (Peters et al., 1997), but these were not representative samples of the population of women with implants. Most reports of complications do not include much if any detail on pain. It was included without discussion in the list of indications for reoperation and was the indication for secondary surgery in 1.1% of the Mayo Clinic group of 749 implanted women (Gabriel et al., 1997), and reports often cite rather low frequencies. Wallace et al. (1996), however, reviewed the subject of pain after breast surgery using a questionnaire with a 59% return rate (282 women). Although the response rate might indicate a bias toward complaints, this group reported substantial local pain after reconstruction (up to 50%) and augmentation (38%). Pain was also more common after submuscular (50%) than submammary (21%), and after saline (33%) than gel (22%), implantation. Since the pain was worse after implantations than after

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Page 177 reduction surgery or mastectomy alone, these authors assumed it was related, at least in part, to the implants, although significant prevalence of chronic postmastectomy pain has been reported in other surveys [12.7-17.4% of patients at various times up to a year postoperative in Kroner et al. (1992), 20% of patients in Stevens et al. (1995)]. Others have reported that pain often recedes after explantation (Peters et al., 1997). Of the augmented and reconstructed patients with pain, 20-29% required pain control medication, though for how long is not clear. Pain is one of the indications for implant removal. Capsule formation, especially under the muscles, may result in nerve compression and pain leading to a requirement for secondary procedures. Other late pain may be due to muscular compression (Huang, 1990). Usually, pain with late onset (8% and 30% of reconstruction and augmentation patients, respectively) represents contracture pain (Wallace et al., 1996). Pain is also associated with some gel implant ruptures, up to 93% in some reports (Ahn et al., 1994b; Andersen et al., 1989), is reported in association with polyurethane implants (Jabaley and Das, 1986; Smahel, 1978a; Wilkinson, 1985), and is reported in association with positive implant bacterial cultures (Parsons et al., 1993; Virden et al., 1992) or calcification around the implant (Peters et al., 1998). There are a number of specific reports of breast pain associated with implantation (Cuéllar and Espinoza, 1996; Huang, 1990; Jabaley and Das, 1986; Janson, 1985; Lu et al., 1993, 1994; Sichere et al., 1995). These reports describe some severe chest, subscapular and arm pain syndromes, and unusual presentations in women with implants, and they list some of the indications for explantation. However, as others have pointed out, chest pain is a common complaint, and evidence to support the association of pain with implants in some of these cases, which come from highly selected groups, is not persuasive (Kulig et al., 1996; Mogelvang, 1996). As Wallace et al. (1996) discuss, pain, like sensory change, which is of similar frequency, is not surprising given the damage to the nerves to the breast and nipple during implantation and reconstruction surgery and the routine injury to the nerves including the intercostobrachial nerve (to the arm) during mastectomy with axillary dissection (Benediktsson et al., 1997 and reviewed in Courtiss and Goldwyn, 1976); see values of 41.6% permanent nipple sensory changes (Fiala et al., 1993); and 41% change (Hetter, 1979); 18% decrease in sensation (Hetter, 1991); nerve damage and paresis (Laban and Kon, 1990; Wallace et al., 1996); and partial to complete sensory loss in the nipple of 70% and in the whole breast of 12% after augmentation, although it should be noted that this was an explant series with a high (65%) incidence of breast pain (Peters et al., 1997).

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Page 178 Conclusions The frequency of local and perioperative complications has been substantial in both augmentation and reconstruction of the breast with either saline- or gel-filled silicone implants. These complications have safety implications, because they may have health consequences of their own and because they may result in further operative or medical interventions that may also have health consequences. The committee sees little justification for some of these interventions, for example, closed capsulotomies or the use of steroids. Much information in this chapter may not apply to the present and may not provide a basis for decisions concerning future experiences because past reports of complications reflect experience with implants having physical and chemical characteristics that differ from current implants and surgical practices that differ from current practices. Although the present state of knowledge does not allow definite conclusions to be drawn about the prevalence or incidence of some complications, some of the more common complications such as rupture, deflation, and contracture may be becoming less frequent due to operative and technological improvements. Information to permit conclusions about the frequency, causes, and management of complications has to be gathered based on research on a stable population of standardized devices. Much remains to be learned about the basic biology of foreign body, silicone, and other polymer interactions with tissue, although progress has been made recently. The committee drew conclusions about ruptures and deflations, the role of silicone in contracture, saline versus gel implants, barrier shells and shell texturing, submuscular placement of implants, the roles of infection and hematomas, the use of adrenal steroid, pain and other outcomes that can affect reoperations and local and perioperative complications. In general, however, the frequency of reoperations and local complications is sufficient to be of concern to the committee and to justify the conclusion that this is the primary safety issue with silicone breast implants, and it is certainly sufficient to require very careful and thorough provision of the kind of information contained in this chapter to women considering breast implant surgery. The committee concludes that many of these risks continue to accumulate over the lifetime of a breast implant.