Breast enlargement was noted in all cases where free intracapsular fluid was present either from implant disruption or severe bleed with exudate formation. White silicone peroxidation was present in 14 breast pockets: in 1 case, this was intraluminal, and 9 of 14 cases were associated with ruptured implants (Fig. 1).
The intraoperative state of the implant and clinical implications were evaluated. Seventeen of the 54 implants removed were stained brown and 37 were white. Ten brown and 2 white implants were ruptured. Three of 17 brown and 5 of 37 white implants showed heavy gel bleed. Brown implants are more likely to be associated with rupture than white implants (OR, 25; 95% CI, 4.468–139.9; P < 0.0001). White implants show less tendency to gel bleed compared with brown implants (P = 0.0003) and hence keep their high profile projection (OR, 8.615; 95% CI, 2.086–35.58; P = 0.0028) when compared with brown implants. Implants associated with heavy gel bleed or rupture (device failure) were more likely to present with thinner intraoperative capsules (OR, 0.1364; 95% CI, 0.03708–0.5015; P = 0.002). Lymphadenopathy is associated with a higher incidence of implant failure (OR, 33; 95% CI, 3.751–290.3; P < 0.0001).
Implant failure and capsular thickness were not associated with bacterial contamination. All intraoperative breast pocket bacterial swabs were negative. Histologically, intraoperative capsules and granulomas showed the presence of foamy macrophages, multinuclear giant cells within fibrovascular tissue.
The presence of iodine in a ruptured and brown-stained PIP implant was determined by inductively coupled plasma mass spectrometry (see Supplemental Digital Content 3, which displays a mass spectrometry report, http://links.lww.com/PRSGO/A57). The results indicated that iodine was present at considerably high concentrations in brown-stained implants compared to previously reported values for “off-the-shelf” PIP implants.5 It would appear that the presence of iodine is specific to the brown implant removed.
Nonmedical silicone gel filler was used in the manufacture of PIP breast implants.4,5,9 The shell elastomer is considered substandard secondary to variable thickness and possibly the omission of the antibleed, fluorinated barrier layer.9–11 PIP implants carry an increased risk of implant failure compared with other implant brands.5,10,12–15 Unacceptably high prevalence of rupture has been reason enough for prophylactic explantation of all PIP implants in some countries.11,13
Due to the inert nature of silicone, rupture has been previously defined as a harmless event that does not produce significant clinical symptoms or activate the humoral immune system, with explantation viewed as mandatory only if silicone migration occurs.16 This criteria cannot be applied to PIP implants due to the scandal surrounding the gel filler. Unscrupulous human behavior during the manufacture of PIP implants means the content of these prostheses cannot be absolutely guaranteed irrespective of testing off-the-shelf samples. The risks associated with tissue being in contact with a filler of unknown origin cannot be predicted although the nonmedical gel filler is believed to not represent a risk to human health.15 Immune responses have been reported.8,9,17 Very little analysis to date has taken place of “used” or explanted implants.9 Patients with asymptomatic device failure carry the gel content in direct contact with the breast parenchyma and may not present for assessment.
Clinically, implant integrity is assessed by history, examination, and diagnostic scan.18 Despite large cohort studies documenting PIP premature failure, there is little documentation of the preoperative clinical signs that are specific to PIP rupture.10,12–14 We have attempted to identify subtle clinical signs and defined them as “soft rupture.” They differ from those quoted in national guidelines and do relate to intraoperative findings in each specific patient.1–3 Detection of these clinical signs could raise the suspicion of rupture early rather than assuming that asymptomatic patients can be left to “watch and wait.” USS can then be applied to support or refute clinical suspicion of rupture.13,14,16,19
The breast consistency changes in soft rupture, becoming soft or doughy. Softening has been correlated with implant failure in previous studies16,18,20 but is not commonly quoted in guidelines as a sign of rupture. Breast enlargement, fullness in the lower pole, and loss of mound project result as free gel, either from bleed or rupture, is no longer constrained within the elastomer envelope. Free gel sitting in the lower pole of the breast pocket with gravity creates a “bottomed out” deformity. The Baker grade of capsule is low in contrast to other implant brands. The capsule constituted a pliable bag containing free intracapsular silicone gel and exudate. The loss of the exaggerated projection of an ultrahigh PIP implant may be the only sign the patient notices on device failure.
Breast enlargement is secondary to intracapsular exudate formation and possibly inflammation of breast parenchyma. The presence of inflammatory cells in the capsule, soft-tissue granulomas, and exudate formation reinforces the suggestion of an immune response.
The nature of the exudate has been discussed in other reports.5,9,12,21 Silicone peroxidation, defined as white exudate, was associated with 9 of 12 cases of implant rupture. This can be part of the liquid exudate, firmly attached to soft tissues (Fig. 3B) or intraluminal (Fig. 1B). Cloudy exudate was commonly seen around implants with severe bleed and is thought to be a suspension of silicone in water5,9 (Fig. 3A). Exudate formation was not associated with an infective process, suggesting that this inflammatory response is secondary to allergens present in the free gel or elastomer shell.
Following implant failure, the capsules around PIP implants were elastic and pliable irrespective of thickness (Fig. 5). None in this series were calcified. Strong adherence to the breast tissue and pectoral fascia was common.22 Other studies have confirmed that PIP implants are not associated with high rates of capsular contracture when compared with other brands.4,5 Multiple causal factors have been implicated in capsule contracture, including the tendency for hypertrophic scar formation.23,24 Because PIP implants have a higher incidence of rupture and gel bleed, free liquid silicone is more likely to be found in direct contact with the capsule compared with other implants.5,10–14 Topical silicone gel reduces hypertrophic scar formation.25–28 The mechanism is not fully understood, but this may be by decreasing fibroblast proliferation.25 Free silicone in direct contact with the capsule may induce the soft, pliable capsules reported.
Brown staining of PIP implants has been noted in other studies,9,12 but the implications have not been evaluated. The integrity of the elastomer shell dictates the stability of the implant. Any defect will result in an increased incidence of device failure. We raised the hypothesis that brown staining of the implant could be a warning sign that the device is more prone to rupture or gel bleed secondary to elastomer envelope failure. If the brown color is due to iodine ingression at the time of primary surgery, then permeability and, hence, integrity of the implant elastomer have to be questioned at a very early stage in the implant’s life span. The analysis of gel content in this study suggests that iodine has permeated across the elastomer. Statistical analysis suggested that there is a higher rate of bleeding and rupture among brown implants. Brown staining has been attributed to ingression of biological fluids in vivo.9,12 The actual causal agent of the discoloration is not of importance. The main point is that the elastomer shell must be inappropriately permeable to allow the gel to stain, and stained implants rupture more commonly.
Outside Wales, a higher proportion of patients have elected to keep their PIP implants or have declined screening.10,14 This, in part, may be due to the fear of relinquishing implants if they are ruptured, and also, if the patients are asymptomatic, they may not appreciate the need for review. It would be beneficial to have a noninvasive diagnostic test that could identify brown implants in this population. Magnetic resonance imaging is not applicable, as no sequence is available that allows iodine detection. The application of dual-energy computed tomographic scanning for the potential detection of iodine needs further exploration.
We believe the symptoms of soft rupture can be clearly defined and should raise suspicion of device failure. These signs and symptoms could be added to current guidelines. A combination of recognition of symptoms of soft rupture and a diagnostic procedure to detect brown implants in situ may be a way forward to monitoring those who elect to keep their PIP implants.
We thank the patients who participated in this study. We thank Professor Fiona Gilbert and Dr. Michael Middleton for their advice concerning radiological screening of PIP implants. We thank Dr. Suzie Howarth for her review of histological samples used in this study. We also thank the Department of Medical Photography at Morriston Hospital for their technical support.
6. Baker JL Jr. Classification of spherical contractures. 1975 Scottsdale, Arizona Presented at the Aesthetic Breast Symposium
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11. Maijers MC, Niessen FB. Prevalence of rupture in Poly Implant Prothèse silicone breast implants, recalled from the European market in 2010. Plast Reconstr Surg. 2012;129:1372–1378
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25. McCauley RL, Riley WB Jr, Juliano RA, et al. In vitro alterations in human fibroblast behavior secondary to silicone polymers. J Surg Res. 1990;49:103–109
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