Foreign material in the capsules around breast prostheses and the cellular reaction to it

Molecular determinants of acute inflammatory responses to biomaterials.

“…Implanted biomaterials frequently trigger inflammatory responses which may, in turn, presage serious iatrogenic consequences such as stress cracking of pacemaker leads (1,2), osteolysis adjacent artificial joints (3)(4)(5), and fibrosis and capsule contracture affecting mammary prostheses (6)(7)(8)(9)(10). The causes of these adverse responses are still obscure, particularly in view of the nontoxic, nonimmunogenic, and chemically inert nature of most implantable biomaterials.…”

Clinicopathologic correlations in pseudocapsule formation after breast augmentation

“…The suspicion of the material being silicone was confirmed by identifying silicium in the pseudocapsule [9,13,15]. Some authors believed that these particles were fragments broken offthe surface of the silicone shell [2,5,9,12,14] with which we agree. However, this does not explain why the pseudocapsules forming around saline-filled implants were generally found to be thinner than those forming around gel-filled silicone implants, although both types of implants have an almost identical silicone shell.…”

“…Subsequently it was felt that the transgressed liquid silicone was responsible for the contamination of the pseudocapsule [2,5,9,12]. Barker et al [2] and Bergman and van der Ende [3] showed in an in vitro study that the gel-filled implants leaked liquid silicone.…”

Breast augmentation surgery: a women's health issue

“…Researchers have demonstrated fairly imequivocally that silicone can leak out of an mtact implant (Brandt et al 1984, Wmgdmg et al 1988 Thomsen et al (1990) con-cluded m their study that leaked silicone caused an inflammatory response withm the tireast capsule Moreover, Smahel (1979) found strong evidence that sihcone particles could reach the lumen of blood vessels in a vanety of ways, thus explainmg the route by which silicone could be earned to other parts of the body Recent reports surest that this may be an issue of some concem Silicone prostheses tiave been strongly linked to the development of human adjuvant disease (HAD), a connective tissue-type disease with a wide vanety of symptoms, including skin tightenmg or thickening and hair loss on the extremities, migratory arthralgias and arttintis (Brozena et al 1988, Sahn et al 1990 This problem appears to be relatively rare, and its low incidence makes it difficult to draw firm conclusions about a casual relationship with implants One group of researchers (Weisman et al 1988) looked for scleroderma-type s}Tnptoms in 125 women with silicone implants and found none, they concluded that 'it does not appear likely that augmentation mammaplasty is a significant or major lnducer of inflammatory connective-tissue diseases m general' They noted, however, that in view of the small sample size, their findings must be considered preliminary Part of the problem in studying HAD is that symptoms are varied and often vague, suggesting that the disease may go undiagnosed As well, in the reported case studies (Brozena et al 1988, Sahn et al 1990, the patients had all had their implants many years tiefore, so it is difficult to make a causal link to the implant However, the fact that removal of the implants resulted in immediate reversal of symptoms is fairly suggestive Rupture Not only does silicone leak out of intact implants, but implants may also mpture According to van Rappard et al (1988), implant ruptures occur in 1% of all augmentation mammaplasties These researchers demonstrated that the pressure generated in closed capsulotomy is sufficient to rupture a senous proportion of implants, and that the older the implant, the less pressure required to break it Of significant concem is the fact that capsular rupture often goes undetected Diagnosis by physical examination IS difficult, as the S5rmptoms can be vague and radiographic reports inconclusive (Theophelis & Stevenson 1986, Andersen et al 1989 Some physical symptoms of implant rupture mclude nodules, decreased breast size, asymmetry, tenderness and a softer texture (Anderson et al 1989) The woman who has undergone a closed capsulotomy should he particularly vigilant m watchmg for such signs It should also t>e noted that breast augments present special problems for mammographers, so it is important that a woman v«th implants seek a facility where the technologist and radiologist have expenence m visualizing the augmented breast…”