Poly Implant Prothèse silicone breast implants: implant dynamics and capsular contracture

Poly Implant Prothèse silicone breast implants: implant dynamics and capsular contracture Background The Poly Implant Prothèse (PIP) implants were withdrawn from the market in 2010 due to the use of low-grade silicone, causing a high risk for implant rupture. The aim of this study was to investigate the implant dynamics of PIP breast implants, as well as to determine the rate and predictors of implant gel bleeding, rupture, and capsular contracture in PIP implants. Methods Eighty women with a total of 152 PIP implants who underwent a reoperation in 2012 were enrolled in this study. Physical investigation included assessing the Baker score and demographics were retrospectively traced in medical records. The pre- and post-operative volumes of the implants were calculated and their state was determined intraoperatively by the surgeon. Results The implants were removed after a mean implant duration of 11 ± 2.1 years. Gel bleed and implant rupture occurred in respectively 42 and 25% of the implants. Intact implants had post-operative volume increase as well as decrease. There was a correlation between gel bleeding and more post-operative implant volume increase (P ≤ 0.05). Capsular contracture had a protective effect against post-operative implant volume increase (P ≤ 0.05), while a post-operative implant volume increase provided a protective influence in developing capsular contracture (P ≤ 0.05). Additionally, implant rupture led to a higher risk of capsular contracture (P ≤ 0.05). Conclusions We managed to illustrate that PIP implant shells were too permeable and that there is a correlation between gel bleeding and the increase of the post-operative implant volume. Implant rupture led to a higher risk for developing capsular contracture. Level of evidence: Level III, risk / prognostic study. . . . Keywords Poly Implant Prothèse PIP Implant dynamics Capsular contracture Introduction question, as physicians started reporting higher rupture rates among patients that were treated with PIP branded implants In 2007, the quality of the silicone breast implants [1, 2]. It was not until 2010 that the French Medical manufactured by Poly Implant Prothèse (PIP) was put into Regulatory Authority (ANSM) declared that silicone breast implants manufactured by PIP were illegally authorized [3]. As a consequence, medical use of the PIP implants was Electronic supplementary material The online version of this article prohibited in several European countries, including the (https://doi.org/10.1007/s00238-018-1427-y) contains supplementary Netherlands. Moreover, the Dutch Health Care Inspectorate material, which is available to authorized users. (IGZ) recommended institutions to have these implants re- moved from the patients. * Y. Bachour yarabachour@gmail.com Several studies have reported on the chemical and physiochemical properties of PIP implants. The ANSM 1 found that the implants contained low-grade silicone gel Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Center, De Boelelaan 1117, PO Box 7057, 1007 and shells, so patients who underwent breast surgery MB Amsterdam, The Netherlands using PIP implants in the past were at a higher risk of Department of Plastic, Reconstructive and Hand Surgery, OLVG an implant shell rupture [3]. Additional tests conducted location West, 1061 AE Amsterdam, The Netherlands 564 Eur J Plast Surg (2018) 41:563–570 Table 1 Baker score of severity of capsular contraction in 2012 by a British NHS Expert Group determined high levels of low molecular weight cyclic siloxanes Baker score Symptoms and signs (D4–6) in PIP silicone gel, but found that these silox- anes did not have cytotoxic or genotoxic effects on the 1 Non-palpable capsule and soft body [4]. Other studies demonstrated that the shell bar- 2 Minimal hardness, not visible rier which should have prevented the implant from 3 Moderate hardness, visible disfiguring bleeding was missing [5, 6]. However, the full effect 4 Hard, painful, cold breasts of the chemical and physiochemical properties of im- plants on the implant dynamics (e.g., shell permeability, gel bleed, and gel rupture) is unknown. analysis, we also excluded patients that primarily Capsular contracture is the most common complica- underwent breast reconstruction, as they constituted a tion after breast implant implantation [7–10]. It occurs minority within the sample (n = 7) and tended to have in 4–17% of esthetic or reconstructive patients that have a higher chance of developing complications compared undergone breast surgery [11]. Symptoms include hard- to breast augmentations [20]. The final cohort com- ening, pain, and deformation of the breast. As a tool to prised of 80 patients with 152 breast reoperations. assess the grade of capsular contracture after palpating All the women who were recalled were first seen in the breast, clinicians use the Baker score, illustrated in the outpatient clinic, where they underwent physical ex- Table 1 [12]. It is unclear what exactly causes capsular amination of the breast and axillae. Each breast was contracture; some hypothesize that a biofilm created af- inspected and palpated and possible axillary lymphomas ter a subclinical bacterial infection stimulates this con- were noted. The four-grade Baker score was then deter- traction [13–16], while others think an immunologic re- mined for the first time. In some cases, the physician sponse is the source [17, 18]. The leakage of silicone (re-) assessed the Baker score at the operation room. In gel has also been associated with contraction of the the cases where the Baker score was determined at the capsule, whether through rupture or gel bleeding [19]. two aforementioned moments, the most recent score was To date, few studies have studied the implant dynam- considered as the final Baker score. A clinical Baker ics and its relationship with capsular contracture. score of 3 or 4 was further considered as capsular con- Therefore, the primary purpose of this study was to tracture in this study. assess the implant dynamics of PIP breast implants Patient medical records were manually reviewed for patient and the risk factors related to these implant dynamics. demographics, surgery-related information, and implant The second purpose of this study was to analyze the characteristics. rate and predictors for developing capsular contracture in PIP implants. Implant characteristics Materials and methods As soon as the implants were surgically removed, their integrity was recorded either as intact, gel bleeding, or Subjects ruptured. Implants were considered intact when no tears were found in the shell. Gel bleeding was reported In 2012, patients that underwent breast augmentation or when the shell was intact but a surrounding substance reconstruction with PIP implants at the OLVG Hospital that stuck to the glove of the surgeon was apparent. in Amsterdam, the Netherlands, were recalled to the Ruptured implants had holes or tears in the shell. All clinic for a reoperation to remove or replace their im- implants were immediately put on a digital weighing plants. The measurements of 102 patients with 194 scale providing the post-operative mass (in grams (gr)). breast augmentations and reconstructions were reported. When the implants were ruptured, as much as possible This study includes a consecutive cohort of patients that of the implant substance was measured. This measuring underwent a reoperation between March 2012 and procedure was attempted in a similar step-by-step man- September 2012 for removal or replacement of their ner by briefed theater nurses. When silicone lymphomas breast implants. (siliconomas) were found during the operation, they Patients who received breast implants other than PIP were removed by the surgeon and sent for pathologic were excluded (n = 35 breasts), as they were reoperated evaluation. for other indications than high risk of rupture. For our Eur J Plast Surg (2018) 41:563–570 565 Table 2 Patient Implant volume versus mass Mean (SD*) characteristics (n =152) Age (years) 53 (12) All the breast implants display their (pre-operative) vol- (n =144) ume information on the package, rather than the mass. Body mass 24 (4.5) As we did not know the pre-operative mass of the im- 2 index (kg/m ) plants and could not contact the manufacturer of PIP in (n =132) order to know the density of the silicone, we measured n (%) the density of an unused PIP implant with the help of Smoker 52 (41%) the Dutch National Institute for Public Health and the (n =137) Environment (RIVM). Using the water displacement Alcohol drinker 80 (58%) method with measuring containers of adequate circum- (n =152) ference, the density was found to be 0.975 g/ml, which Breast side: left 77 (51%) we used to convert the post-operative mass to volume. Mean (SD*) This converted volume was used in the analyses. Years between 11 (2.1) operations (n =132) Statistical analysis Baker score: n (%) Score 1 77 (58%) The object of investigation was both the woman and the Score 2 37 (28%) breast. Statistical analysis was done per breast. As most Score 3 11 (8.3%) patients were operated on both breasts, the usual ran- Score 4 7 (5.3%) dom effect that an unselected group of individual study objects should provide was not achieved as when using *SD standard deviation the breasts for analyses. We tested this with the use of Intra-class Coefficient Correlation tests. In order to cor- rect this variance, multi-leveled tests were used for uni- divided, with 51% having had a breast implant on the variate as well as for multivariate analyses. For the left side of the body. The bra size could not be used for nominal outcomes, a generalized linear mixed model further analyses as there was not enough variable data test was used. For the dichotomous outcomes, we used for the tests. Breast implants were implanted for a mean the generalized estimating equations (GEE) test. of 11 ± 2.1 years. The majority of the patients did not Multivariable logistic regression analysis was done for have capsular contracture. Baker scores were 1 in 58%, all clinically relevant factors, as illustrated in the respec- 2 in 28%, 3 in 8.3%, and 4 in 5.3%. Table 2 summa- tive tables. We corrected for variables which could be rizes these patient characteristics. There were two pa- possible confounders. These were the patient-related tients that developed siliconomas, which was too small characteristics: age, body mass index, alcohol drinking, a number to use in further analyses. and years between operations. As, overall, this did not The PIP implants were all round and textured. Post- lead to relevant changes in the results, these outcomes operative measurements showed a decrease in volume in are not portrayed in the tables. 19% of the implants and an increase in 62%. In 19% of Results were reported as odds ratios (OR) with 95% confidence intervals (CI) and P values. A two-tailed P Table 3 Breast implant characteristics (n =152) value of less than 0.05 was considered statistically sig- nificant. All statistical analyses were performed using n (%) SPSS® 22 (SPSS, Inc., Illinois, USA). Implant volume post-operatively: (n =139) No change 26 (19%) Results Decrease 26 (19%) Increase 87 (62%) The mean age of the 80 patients at the time of explan- Implant state post-operatively: (n =151) tation was 53 ± 12 years. The mean body mass index Intact 50 (33%) was 24 ± 4.5 kg/m which falls under the category of Gel bleed 64 (42%) normal weight. There were 41% smokers and 58% re- Ruptured 37 (25%) ported alcohol intake. Breast sides were almost equally 566 Eur J Plast Surg (2018) 41:563–570 Table 4 Univariable logistic regression of outcome post-operative im- Table 5 Univariable logistic regression of outcome post-operative im- plant volume analyzed per variable (n = 152) plant state analyzed per variable (n = 152) Odds ratio (95% CI*) P value Odds ratio (95% CI*) P value Age Age Decrease 1.04 (0.98 to 1.1) 0.22 Gel bleed 0.97 (0.92 to 1.01) 0.13 Increase 0.97 (0.93 to 1.0) 0.16 Rupture 0.99 (0.95 to 1.03) 0.70 Body mass index Body mass index Decrease 0.92 (0.79 to 1.1) 0.30 Gel bleed 1.0 (0.92 to 1.2) 0.56 Increase 1.01 (0.90 to 1.1) 0.87 Rupture 1.1 (0.98 to 1.2) 0.096 Alcohol drinking Alcohol drinking Decrease 0.50 (0.13 to 2.0) 0.32 Gel bleed 0.56 (0.18 to 1.7) 0.30 Increase 0.66 (0.21 to 2.0) 0.46 Rupture 0.70 (0.25 to 2.0) 0.49 Years between operations Years between operations Decrease 1.2 (0.79 to 1.7) 0.47 Gel bleed 0.93 (0.70 to 1.2) 0.61 Increase 1.001 (0.77 to 1.3) 0.99 Rupture 1.1 (0.77 to 1.5) 0.70 Capsular contracture Capsular contracture Decrease 0.75 (0.17 to 3.4) 0.71 Gel bleed 0.39 (0.073 to 2.1) 0.27 Increase 0.15 (0.036 to 0.59) < 0.05 Rupture 1.6 (0.43 to 6.0) 0.49 Implant size Implant Size Decrease 1.02 (1.01 to 1.03) < 0.05 Gel bleed 1.01 (1.0 to 1.02) 0.052 Increase 1.02 (1.02 to 1.03) < 0.05 Rupture 1.01 (0.999 to 1.01) 0.081 Gel bleed Post-operative implant volume Decrease 0.25 (0.043 to 1.4) 0.12 Decrease Increase 4.3 (1.5 to 13) < 0.05 Gel bleed 0.65 (0.21 to 2.1) 0.47 Increase *95% CI 95% confidence interval Gel bleed 3.4 (1.4 to 8.3) < 0.05 *95% CI 95% confidence interval the implants, there was no change in the post-operative volume. There was a well-divided group regarding post- operative implant state, with 33% intact, 42% with gel bleeding, and 25% ruptured (Table 3). Of the 18 breasts that developed capsular contracture, 39% had intact im- Table 6 Univariable logistic regression of outcome capsular plants, 22% gel bleed, and 39% ruptured. contracture analyzed per variable (n =152) Figure 1 in the supplementary file shows a graphical Odds ratio (95% CI*) P value portrayal of the post-operative implant volume differ- ences, separated per implant state group. Besides a few Age 1.0 (0.98 to 1.1) 0.21 outliers, it is of interest to note an increase in implant Body mass index 1.1 (0.82 to 1.4) 0.69 volume in both intact and gel bleeding implants. Alcohol drinking 0.53 (0.053 to 5.3) 0.59 In the implant-related outcomes, it was not relevant or Years between operations 0.74 (0.51 to 1.1) 0.11 statistically possible to analyze the relationships between Implant size 1.0 (0.99 to 1.0) 0.25 the ruptured implant variable and the post-operative im- Implant state (comparison: intact) plant volume, as the post-operative implant volume of Gel bleed 0.61 (0.22 to 1.7) 0.33 ruptured implants logically only had a decrease in Rupture 1.8 (1.01 to 3.1) < 0.05 volume. Post-operative implant volume The associations resulting in a post-operative volume Decrease 0.35 (0.68 to 1.8) 0.22 decrease or increase are portrayed in Table 4.Capsular Increase 0.23 (0.081 to 0.63) < 0.05 contracture resulted in a lower risk of post-operative im- plant volume increase (OR = 0.15 CI = 0.036–0.59, P ≤ *95% CI 95% confidence interval Eur J Plast Surg (2018) 41:563–570 567 0.05). There appears to be a significant association be- silicone out of the intact implant shell, it is striking that tween bigger implant sizes and post-operative volume dif- no relation was found between gel bleeding and post- ferences. As the OR is close to 1.0 for both post-operative operative implant volume decrease, as one would expect implant volume decrease (OR = 1.02 CI = 1.01–1.03, P ≤ that the exuding of silicone could make the implant 0.05), as well as for post-operative implant volume in- lighter. This finding backs the statement that the PIP crease (OR = 1.02 CI = 1.02–1.03, P ≤ 0.05), this associa- implant shells were too permeable. Beretta et al. [21] tion is not valid enough to have meaningful conclusions. studied the (physico)chemical properties of PIP silicone, When gel bleed was found as the post-operative implant comparing it with silicone from a McGhan implant state, there was a higher chance of developing an in- model. They concluded that the silicone used by PIP creased post-operative implant volume. In univariate anal- was low-cohesive because of the method used to man- ysis, the OR was 4.3 with CI = 1.5–13, (P ≤ 0.05), show- ufacture the chemicals, where polymers were not prop- ing an apparent higher risk. erly cross-linked. They proved that this silicone gel Table 5 shows the analysis for the outcome of the could adsorb substances like cholesterol from surround- post-operative implant state. For implants with a post- ing tissue, which could in turn lead to a lower viscosity operative increase in volume, there is a 3.4 higher risk and eventually higher risk of rupture. In a subsequent for developing gel bleed, with OR of 3.4 (CI = 1.4–8.3, study, Beretta et al. [22] analyzed the biochemical struc- P ≤0.05). ture of accumulated fluid around PIP implants. They The associations related to capsular contracture can showed that low and high molecular weight silicone be found in Table 6. Post-operative implant shell rup- can diffuse not only out of the implant shell but also ture led to a higher chance of capsular contracture with out of the capsule formed around the implant and into an OR of 1.8 (CI = 1.01–3.1, P = 0.044). An increased the body. They also managed to illustrate that, besides post-operative implant volume was related to a lower cholesterol, other endogenous substances like uric acid, risk of developing capsular contracture with an OR of globulins, and albumin could enter the implant shell. 0.23 (CI = 0.081–0.63, P ≤ 0.05). They hypothesized that this diffusion occurs because of the osmotic power present and might be responsible for the increase in volume despite the gel bleed. Swarts Discussion et al. [5] also reported a higher risk of implant rupture due to lack of impermeability. PIP implant shells were The primary aim of this study was to assess the implant proven to have been manufactured with inconstant de- dynamics of PIP breast implants and the risk factors grees of thickness, sharp edges, and miniature holes in related to these implant dynamics. The second purpose the hollow parts of textured shells. Additionally, the of this study was to analyze the rate and predictors for anti-bleeding barrier layer that is customarily fabricated in modern implants appeared to not have been included developing capsular contracture in PIP implants. This study shows that the PIP implant shell was highly per- in the PIP implant model since 2007 [5]. The previous finding is strengthened, since a post- meable, leading to an increase or decrease in volume of the implant over the years. Capsular contracture and operative implant volume increase seems to lead to a 3.4 (P ≤ 0.05) higher risk of developing gel bleeding. post-operative implant volume increase had a preventa- tive effect on each other. Gel bleeding related to more If we hypothesize that the implant volume increased before the start of gel bleeding, one could argue that a implant volume increase and the other way around. Finally, the rupturing of implants led to higher capsular larger content in the implant shell leads to a higher contracture rates. mechanical pressure and eventually leakage of silicone Capsular contracture poses a protective risk (OR = into the surrounding tissue. In the case that this process 0.15, P ≤ 0.05) against a post-operative implant volume does not occur in that strict order, it is still very appar- ent that the PIP implant shell worked as an unsuitable increase. A possible explanation is that the capsule sur- rounding the breast implant grows thicker and loses protective layer that lets fluid through in both directions. elasticity. Therefore, there is no space for the implant to expand. Regarding risks for developing capsular contracture, ruptured implants at explantation were associated with Gel bleeding demonstrated a 4.3 (P ≤ 0.05) higher risk of increase in post-operative implant volume. an OR of 1.8 (P ≤ 0.05). Studies by Feng et al. [23]and Holmich et al. [24] found similar risks. The large Since the definition of gel bleeding is the diffusion of 568 Eur J Plast Surg (2018) 41:563–570 amount of silicone that is released after rupture could be analyses. Furthermore, there appeared to be three differ- a stimulus of the process of contracture. Alternatively, it ent batches of silicone used in the implants throughout could also be the effect of the mechanical changes of the years. The PIP silicone used to measure density was the ruptured implant that in turn cause friction with the of the PIP2 batch, while the PIP implants of our cohort surrounding tissue, leading to the formation of fibrous were predominantly from the PIP1 or NUSIL batch tissue. The opposite is also possible, namely, that cap- [33]. Although this density was the closest way of de- sular contracture leads to the rupturing of implants be- termining the post-operative volume, it might not be cause of a higher mechanical pressure on them. Our completely applicable to every PIP implant model used, cohort showed a rupture rate of 25%, which is compa- as there is no traceable record of the component of rable with the literature that reported a wide range of different batches. 3.9 to 31.6% [25–32]. Breasts that developed capsular With acohortofthissizeandtheretrospectivede- contracture contained ruptured implants in 33% of the sign of this study, a conclusion can be limited due to a cases, which was not increased in comparison to intact high chance of bias, loss of data, or confounding fac- (39%) and gel bleeding (22%) implants. tors. Missing data was considered random, since the Additionally, post-operative implant volume increase investigators who collected the data were independent seems to have a protective effect (OR = 0.23, P ≤ 0.05) from the involved physicians in the patient care and against capsular contracture. Again, the capsular con- only used data accessible in patient files. Also, this tracture surrounding the implant could prevent any pos- led to different sizes of variable groups, which made sible expansion of the implant, because the contracted multivariable statistical analysis less reliable. A consid- capsules tend to tighten around it. Since it is not pos- erable advantage of our group was the follow-up time sible to determine which phenomenon develops first, of 11 ± 2.1 years, which is a clinically satisfactory this outcome can, in the least, be interpreted as there amount of time of implantation to observe the impact being a clear association betweenthetwovariables. implants can have on the body and vice-versa. This The results of our study point towards the fact that study set-up was, to our knowledge, the first of its kind, PIP implant shells indeed lacked adequate impermeabil- measuring the post-operative implant volume difference ity and thus were prone to develop a change in post- in a cohort of this size and relating it to the post- operative implant volumes. This, in combination with operative implant state and development of capsular low-quality silicone gel, provides a high risk for rupture contracture. and, thus, a higher probability for developing capsular In conclusion, we illustrated that the elastomer shells contracture. of PIP implants were functioning deficiently, since our cohort has shown that volume increase as well as de- In evaluation of our study, we acknowledge that our study was conducted on a targeted group of patients crease widely occurred. Consequently, there seems to be following the PIP incident. What can be perceived as a correlation between gel bleeding implants and the in- a limitation is the fact that these implants have been creasing of the post-operative implant volume. In con- banned from use. However, due to the consequences trast, capsular contracture could have a protective effect of the PIP breast implant scandal and the high explan- against post-operative implant volume increase, and a tation rate, there have been many studies published on post-operative implant volume increase could also pro- different aspects of this particular breast implant. This vide a protective influence in developing capsular con- provides us with the opportunity to relate the different tracture. Additionally, implant ruptures led to a higher aspects to factors that influence shell rupture, gel bleed- probability for capsular contracture. We unquestionably ing, and capsular contracture, all of which are compli- encourage more research on the dynamics of breast im- cations regularly occurring in patients with new models plants, particularly with implant models that are current- of breast implants. If we can compare these factors in ly on the market. We also urge official health institu- the PIP implants, and compare the identified factors tions to implement stricter guidelines following Hazard with breast implants that are currently being used, we Analysis and Critical Control Points (HACCP) to ensure will be able to better understand the causes for these a higher quality of breast implants and thus better pa- complications. One major limitation that this scenario tient safety. offers is the lack of a control group. Comparison of Acknowledgements We would like to thank Peter Keizers (PhD, our data with other brands of implants could have pro- National Institute for Public Health and the Environment, Bilthoven, vided a more clinically relevant outcome for our Eur J Plast Surg (2018) 41:563–570 569 The Netherlands) who offered expert advice on the chemical structure and tracture after prosthetic breast reconstruction. Plast Reconstr Surg development of the PIP implants. 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J Plast Reconstr Aesthet Surg 66(9):1182–1187 AFSSAPS, Paris 70 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png European Journal of Plastic Surgery Springer Journals

Poly Implant Prothèse silicone breast implants: implant dynamics and capsular contracture

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Abstract

Background The Poly Implant Prothèse (PIP) implants were withdrawn from the market in 2010 due to the use of low-grade silicone, causing a high risk for implant rupture. The aim of this study was to investigate the implant dynamics of PIP breast implants, as well as to determine the rate and predictors of implant gel bleeding, rupture, and capsular contracture in PIP implants. Methods Eighty women with a total of 152 PIP implants who underwent a reoperation in 2012 were enrolled in this study. Physical investigation included assessing the Baker score and demographics were retrospectively traced in medical records. The pre- and post-operative volumes of the implants were calculated and their state was determined intraoperatively by the surgeon. Results The implants were removed after a mean implant duration of 11 ± 2.1 years. Gel bleed and implant rupture occurred in respectively 42 and 25% of the implants. Intact implants had post-operative volume increase as well as decrease. There was a correlation between gel bleeding and more post-operative implant volume increase (P ≤ 0.05). Capsular contracture had a protective effect against post-operative implant volume increase (P ≤ 0.05), while a post-operative implant volume increase provided a protective influence in developing capsular contracture (P ≤ 0.05). Additionally, implant rupture led to a higher risk of capsular contracture (P ≤ 0.05). Conclusions We managed to illustrate that PIP implant shells were too permeable and that there is a correlation between gel bleeding and the increase of the post-operative implant volume. Implant rupture led to a higher risk for developing capsular contracture. Level of evidence: Level III, risk / prognostic study. . . . Keywords Poly Implant Prothèse PIP Implant dynamics Capsular contracture Introduction question, as physicians started reporting higher rupture rates among patients that were treated with PIP branded implants In 2007, the quality of the silicone breast implants [1, 2]. It was not until 2010 that the French Medical manufactured by Poly Implant Prothèse (PIP) was put into Regulatory Authority (ANSM) declared that silicone breast implants manufactured by PIP were illegally authorized [3]. As a consequence, medical use of the PIP implants was Electronic supplementary material The online version of this article prohibited in several European countries, including the (https://doi.org/10.1007/s00238-018-1427-y) contains supplementary Netherlands. Moreover, the Dutch Health Care Inspectorate material, which is available to authorized users. (IGZ) recommended institutions to have these implants re- moved from the patients. * Y. Bachour yarabachour@gmail.com Several studies have reported on the chemical and physiochemical properties of PIP implants. The ANSM 1 found that the implants contained low-grade silicone gel Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Center, De Boelelaan 1117, PO Box 7057, 1007 and shells, so patients who underwent breast surgery MB Amsterdam, The Netherlands using PIP implants in the past were at a higher risk of Department of Plastic, Reconstructive and Hand Surgery, OLVG an implant shell rupture [3]. Additional tests conducted location West, 1061 AE Amsterdam, The Netherlands 564 Eur J Plast Surg (2018) 41:563–570 Table 1 Baker score of severity of capsular contraction in 2012 by a British NHS Expert Group determined high levels of low molecular weight cyclic siloxanes Baker score Symptoms and signs (D4–6) in PIP silicone gel, but found that these silox- anes did not have cytotoxic or genotoxic effects on the 1 Non-palpable capsule and soft body [4]. Other studies demonstrated that the shell bar- 2 Minimal hardness, not visible rier which should have prevented the implant from 3 Moderate hardness, visible disfiguring bleeding was missing [5, 6]. However, the full effect 4 Hard, painful, cold breasts of the chemical and physiochemical properties of im- plants on the implant dynamics (e.g., shell permeability, gel bleed, and gel rupture) is unknown. analysis, we also excluded patients that primarily Capsular contracture is the most common complica- underwent breast reconstruction, as they constituted a tion after breast implant implantation [7–10]. It occurs minority within the sample (n = 7) and tended to have in 4–17% of esthetic or reconstructive patients that have a higher chance of developing complications compared undergone breast surgery [11]. Symptoms include hard- to breast augmentations [20]. The final cohort com- ening, pain, and deformation of the breast. As a tool to prised of 80 patients with 152 breast reoperations. assess the grade of capsular contracture after palpating All the women who were recalled were first seen in the breast, clinicians use the Baker score, illustrated in the outpatient clinic, where they underwent physical ex- Table 1 [12]. It is unclear what exactly causes capsular amination of the breast and axillae. Each breast was contracture; some hypothesize that a biofilm created af- inspected and palpated and possible axillary lymphomas ter a subclinical bacterial infection stimulates this con- were noted. The four-grade Baker score was then deter- traction [13–16], while others think an immunologic re- mined for the first time. In some cases, the physician sponse is the source [17, 18]. The leakage of silicone (re-) assessed the Baker score at the operation room. In gel has also been associated with contraction of the the cases where the Baker score was determined at the capsule, whether through rupture or gel bleeding [19]. two aforementioned moments, the most recent score was To date, few studies have studied the implant dynam- considered as the final Baker score. A clinical Baker ics and its relationship with capsular contracture. score of 3 or 4 was further considered as capsular con- Therefore, the primary purpose of this study was to tracture in this study. assess the implant dynamics of PIP breast implants Patient medical records were manually reviewed for patient and the risk factors related to these implant dynamics. demographics, surgery-related information, and implant The second purpose of this study was to analyze the characteristics. rate and predictors for developing capsular contracture in PIP implants. Implant characteristics Materials and methods As soon as the implants were surgically removed, their integrity was recorded either as intact, gel bleeding, or Subjects ruptured. Implants were considered intact when no tears were found in the shell. Gel bleeding was reported In 2012, patients that underwent breast augmentation or when the shell was intact but a surrounding substance reconstruction with PIP implants at the OLVG Hospital that stuck to the glove of the surgeon was apparent. in Amsterdam, the Netherlands, were recalled to the Ruptured implants had holes or tears in the shell. All clinic for a reoperation to remove or replace their im- implants were immediately put on a digital weighing plants. The measurements of 102 patients with 194 scale providing the post-operative mass (in grams (gr)). breast augmentations and reconstructions were reported. When the implants were ruptured, as much as possible This study includes a consecutive cohort of patients that of the implant substance was measured. This measuring underwent a reoperation between March 2012 and procedure was attempted in a similar step-by-step man- September 2012 for removal or replacement of their ner by briefed theater nurses. When silicone lymphomas breast implants. (siliconomas) were found during the operation, they Patients who received breast implants other than PIP were removed by the surgeon and sent for pathologic were excluded (n = 35 breasts), as they were reoperated evaluation. for other indications than high risk of rupture. For our Eur J Plast Surg (2018) 41:563–570 565 Table 2 Patient Implant volume versus mass Mean (SD*) characteristics (n =152) Age (years) 53 (12) All the breast implants display their (pre-operative) vol- (n =144) ume information on the package, rather than the mass. Body mass 24 (4.5) As we did not know the pre-operative mass of the im- 2 index (kg/m ) plants and could not contact the manufacturer of PIP in (n =132) order to know the density of the silicone, we measured n (%) the density of an unused PIP implant with the help of Smoker 52 (41%) the Dutch National Institute for Public Health and the (n =137) Environment (RIVM). Using the water displacement Alcohol drinker 80 (58%) method with measuring containers of adequate circum- (n =152) ference, the density was found to be 0.975 g/ml, which Breast side: left 77 (51%) we used to convert the post-operative mass to volume. Mean (SD*) This converted volume was used in the analyses. Years between 11 (2.1) operations (n =132) Statistical analysis Baker score: n (%) Score 1 77 (58%) The object of investigation was both the woman and the Score 2 37 (28%) breast. Statistical analysis was done per breast. As most Score 3 11 (8.3%) patients were operated on both breasts, the usual ran- Score 4 7 (5.3%) dom effect that an unselected group of individual study objects should provide was not achieved as when using *SD standard deviation the breasts for analyses. We tested this with the use of Intra-class Coefficient Correlation tests. In order to cor- rect this variance, multi-leveled tests were used for uni- divided, with 51% having had a breast implant on the variate as well as for multivariate analyses. For the left side of the body. The bra size could not be used for nominal outcomes, a generalized linear mixed model further analyses as there was not enough variable data test was used. For the dichotomous outcomes, we used for the tests. Breast implants were implanted for a mean the generalized estimating equations (GEE) test. of 11 ± 2.1 years. The majority of the patients did not Multivariable logistic regression analysis was done for have capsular contracture. Baker scores were 1 in 58%, all clinically relevant factors, as illustrated in the respec- 2 in 28%, 3 in 8.3%, and 4 in 5.3%. Table 2 summa- tive tables. We corrected for variables which could be rizes these patient characteristics. There were two pa- possible confounders. These were the patient-related tients that developed siliconomas, which was too small characteristics: age, body mass index, alcohol drinking, a number to use in further analyses. and years between operations. As, overall, this did not The PIP implants were all round and textured. Post- lead to relevant changes in the results, these outcomes operative measurements showed a decrease in volume in are not portrayed in the tables. 19% of the implants and an increase in 62%. In 19% of Results were reported as odds ratios (OR) with 95% confidence intervals (CI) and P values. A two-tailed P Table 3 Breast implant characteristics (n =152) value of less than 0.05 was considered statistically sig- nificant. All statistical analyses were performed using n (%) SPSS® 22 (SPSS, Inc., Illinois, USA). Implant volume post-operatively: (n =139) No change 26 (19%) Results Decrease 26 (19%) Increase 87 (62%) The mean age of the 80 patients at the time of explan- Implant state post-operatively: (n =151) tation was 53 ± 12 years. The mean body mass index Intact 50 (33%) was 24 ± 4.5 kg/m which falls under the category of Gel bleed 64 (42%) normal weight. There were 41% smokers and 58% re- Ruptured 37 (25%) ported alcohol intake. Breast sides were almost equally 566 Eur J Plast Surg (2018) 41:563–570 Table 4 Univariable logistic regression of outcome post-operative im- Table 5 Univariable logistic regression of outcome post-operative im- plant volume analyzed per variable (n = 152) plant state analyzed per variable (n = 152) Odds ratio (95% CI*) P value Odds ratio (95% CI*) P value Age Age Decrease 1.04 (0.98 to 1.1) 0.22 Gel bleed 0.97 (0.92 to 1.01) 0.13 Increase 0.97 (0.93 to 1.0) 0.16 Rupture 0.99 (0.95 to 1.03) 0.70 Body mass index Body mass index Decrease 0.92 (0.79 to 1.1) 0.30 Gel bleed 1.0 (0.92 to 1.2) 0.56 Increase 1.01 (0.90 to 1.1) 0.87 Rupture 1.1 (0.98 to 1.2) 0.096 Alcohol drinking Alcohol drinking Decrease 0.50 (0.13 to 2.0) 0.32 Gel bleed 0.56 (0.18 to 1.7) 0.30 Increase 0.66 (0.21 to 2.0) 0.46 Rupture 0.70 (0.25 to 2.0) 0.49 Years between operations Years between operations Decrease 1.2 (0.79 to 1.7) 0.47 Gel bleed 0.93 (0.70 to 1.2) 0.61 Increase 1.001 (0.77 to 1.3) 0.99 Rupture 1.1 (0.77 to 1.5) 0.70 Capsular contracture Capsular contracture Decrease 0.75 (0.17 to 3.4) 0.71 Gel bleed 0.39 (0.073 to 2.1) 0.27 Increase 0.15 (0.036 to 0.59) < 0.05 Rupture 1.6 (0.43 to 6.0) 0.49 Implant size Implant Size Decrease 1.02 (1.01 to 1.03) < 0.05 Gel bleed 1.01 (1.0 to 1.02) 0.052 Increase 1.02 (1.02 to 1.03) < 0.05 Rupture 1.01 (0.999 to 1.01) 0.081 Gel bleed Post-operative implant volume Decrease 0.25 (0.043 to 1.4) 0.12 Decrease Increase 4.3 (1.5 to 13) < 0.05 Gel bleed 0.65 (0.21 to 2.1) 0.47 Increase *95% CI 95% confidence interval Gel bleed 3.4 (1.4 to 8.3) < 0.05 *95% CI 95% confidence interval the implants, there was no change in the post-operative volume. There was a well-divided group regarding post- operative implant state, with 33% intact, 42% with gel bleeding, and 25% ruptured (Table 3). Of the 18 breasts that developed capsular contracture, 39% had intact im- Table 6 Univariable logistic regression of outcome capsular plants, 22% gel bleed, and 39% ruptured. contracture analyzed per variable (n =152) Figure 1 in the supplementary file shows a graphical Odds ratio (95% CI*) P value portrayal of the post-operative implant volume differ- ences, separated per implant state group. Besides a few Age 1.0 (0.98 to 1.1) 0.21 outliers, it is of interest to note an increase in implant Body mass index 1.1 (0.82 to 1.4) 0.69 volume in both intact and gel bleeding implants. Alcohol drinking 0.53 (0.053 to 5.3) 0.59 In the implant-related outcomes, it was not relevant or Years between operations 0.74 (0.51 to 1.1) 0.11 statistically possible to analyze the relationships between Implant size 1.0 (0.99 to 1.0) 0.25 the ruptured implant variable and the post-operative im- Implant state (comparison: intact) plant volume, as the post-operative implant volume of Gel bleed 0.61 (0.22 to 1.7) 0.33 ruptured implants logically only had a decrease in Rupture 1.8 (1.01 to 3.1) < 0.05 volume. Post-operative implant volume The associations resulting in a post-operative volume Decrease 0.35 (0.68 to 1.8) 0.22 decrease or increase are portrayed in Table 4.Capsular Increase 0.23 (0.081 to 0.63) < 0.05 contracture resulted in a lower risk of post-operative im- plant volume increase (OR = 0.15 CI = 0.036–0.59, P ≤ *95% CI 95% confidence interval Eur J Plast Surg (2018) 41:563–570 567 0.05). There appears to be a significant association be- silicone out of the intact implant shell, it is striking that tween bigger implant sizes and post-operative volume dif- no relation was found between gel bleeding and post- ferences. As the OR is close to 1.0 for both post-operative operative implant volume decrease, as one would expect implant volume decrease (OR = 1.02 CI = 1.01–1.03, P ≤ that the exuding of silicone could make the implant 0.05), as well as for post-operative implant volume in- lighter. This finding backs the statement that the PIP crease (OR = 1.02 CI = 1.02–1.03, P ≤ 0.05), this associa- implant shells were too permeable. Beretta et al. [21] tion is not valid enough to have meaningful conclusions. studied the (physico)chemical properties of PIP silicone, When gel bleed was found as the post-operative implant comparing it with silicone from a McGhan implant state, there was a higher chance of developing an in- model. They concluded that the silicone used by PIP creased post-operative implant volume. In univariate anal- was low-cohesive because of the method used to man- ysis, the OR was 4.3 with CI = 1.5–13, (P ≤ 0.05), show- ufacture the chemicals, where polymers were not prop- ing an apparent higher risk. erly cross-linked. They proved that this silicone gel Table 5 shows the analysis for the outcome of the could adsorb substances like cholesterol from surround- post-operative implant state. For implants with a post- ing tissue, which could in turn lead to a lower viscosity operative increase in volume, there is a 3.4 higher risk and eventually higher risk of rupture. In a subsequent for developing gel bleed, with OR of 3.4 (CI = 1.4–8.3, study, Beretta et al. [22] analyzed the biochemical struc- P ≤0.05). ture of accumulated fluid around PIP implants. They The associations related to capsular contracture can showed that low and high molecular weight silicone be found in Table 6. Post-operative implant shell rup- can diffuse not only out of the implant shell but also ture led to a higher chance of capsular contracture with out of the capsule formed around the implant and into an OR of 1.8 (CI = 1.01–3.1, P = 0.044). An increased the body. They also managed to illustrate that, besides post-operative implant volume was related to a lower cholesterol, other endogenous substances like uric acid, risk of developing capsular contracture with an OR of globulins, and albumin could enter the implant shell. 0.23 (CI = 0.081–0.63, P ≤ 0.05). They hypothesized that this diffusion occurs because of the osmotic power present and might be responsible for the increase in volume despite the gel bleed. Swarts Discussion et al. [5] also reported a higher risk of implant rupture due to lack of impermeability. PIP implant shells were The primary aim of this study was to assess the implant proven to have been manufactured with inconstant de- dynamics of PIP breast implants and the risk factors grees of thickness, sharp edges, and miniature holes in related to these implant dynamics. The second purpose the hollow parts of textured shells. Additionally, the of this study was to analyze the rate and predictors for anti-bleeding barrier layer that is customarily fabricated in modern implants appeared to not have been included developing capsular contracture in PIP implants. This study shows that the PIP implant shell was highly per- in the PIP implant model since 2007 [5]. The previous finding is strengthened, since a post- meable, leading to an increase or decrease in volume of the implant over the years. Capsular contracture and operative implant volume increase seems to lead to a 3.4 (P ≤ 0.05) higher risk of developing gel bleeding. post-operative implant volume increase had a preventa- tive effect on each other. Gel bleeding related to more If we hypothesize that the implant volume increased before the start of gel bleeding, one could argue that a implant volume increase and the other way around. Finally, the rupturing of implants led to higher capsular larger content in the implant shell leads to a higher contracture rates. mechanical pressure and eventually leakage of silicone Capsular contracture poses a protective risk (OR = into the surrounding tissue. In the case that this process 0.15, P ≤ 0.05) against a post-operative implant volume does not occur in that strict order, it is still very appar- ent that the PIP implant shell worked as an unsuitable increase. A possible explanation is that the capsule sur- rounding the breast implant grows thicker and loses protective layer that lets fluid through in both directions. elasticity. Therefore, there is no space for the implant to expand. Regarding risks for developing capsular contracture, ruptured implants at explantation were associated with Gel bleeding demonstrated a 4.3 (P ≤ 0.05) higher risk of increase in post-operative implant volume. an OR of 1.8 (P ≤ 0.05). Studies by Feng et al. [23]and Holmich et al. [24] found similar risks. The large Since the definition of gel bleeding is the diffusion of 568 Eur J Plast Surg (2018) 41:563–570 amount of silicone that is released after rupture could be analyses. Furthermore, there appeared to be three differ- a stimulus of the process of contracture. Alternatively, it ent batches of silicone used in the implants throughout could also be the effect of the mechanical changes of the years. The PIP silicone used to measure density was the ruptured implant that in turn cause friction with the of the PIP2 batch, while the PIP implants of our cohort surrounding tissue, leading to the formation of fibrous were predominantly from the PIP1 or NUSIL batch tissue. The opposite is also possible, namely, that cap- [33]. Although this density was the closest way of de- sular contracture leads to the rupturing of implants be- termining the post-operative volume, it might not be cause of a higher mechanical pressure on them. Our completely applicable to every PIP implant model used, cohort showed a rupture rate of 25%, which is compa- as there is no traceable record of the component of rable with the literature that reported a wide range of different batches. 3.9 to 31.6% [25–32]. Breasts that developed capsular With acohortofthissizeandtheretrospectivede- contracture contained ruptured implants in 33% of the sign of this study, a conclusion can be limited due to a cases, which was not increased in comparison to intact high chance of bias, loss of data, or confounding fac- (39%) and gel bleeding (22%) implants. tors. Missing data was considered random, since the Additionally, post-operative implant volume increase investigators who collected the data were independent seems to have a protective effect (OR = 0.23, P ≤ 0.05) from the involved physicians in the patient care and against capsular contracture. Again, the capsular con- only used data accessible in patient files. Also, this tracture surrounding the implant could prevent any pos- led to different sizes of variable groups, which made sible expansion of the implant, because the contracted multivariable statistical analysis less reliable. A consid- capsules tend to tighten around it. Since it is not pos- erable advantage of our group was the follow-up time sible to determine which phenomenon develops first, of 11 ± 2.1 years, which is a clinically satisfactory this outcome can, in the least, be interpreted as there amount of time of implantation to observe the impact being a clear association betweenthetwovariables. implants can have on the body and vice-versa. This The results of our study point towards the fact that study set-up was, to our knowledge, the first of its kind, PIP implant shells indeed lacked adequate impermeabil- measuring the post-operative implant volume difference ity and thus were prone to develop a change in post- in a cohort of this size and relating it to the post- operative implant volumes. This, in combination with operative implant state and development of capsular low-quality silicone gel, provides a high risk for rupture contracture. and, thus, a higher probability for developing capsular In conclusion, we illustrated that the elastomer shells contracture. of PIP implants were functioning deficiently, since our cohort has shown that volume increase as well as de- In evaluation of our study, we acknowledge that our study was conducted on a targeted group of patients crease widely occurred. Consequently, there seems to be following the PIP incident. What can be perceived as a correlation between gel bleeding implants and the in- a limitation is the fact that these implants have been creasing of the post-operative implant volume. In con- banned from use. However, due to the consequences trast, capsular contracture could have a protective effect of the PIP breast implant scandal and the high explan- against post-operative implant volume increase, and a tation rate, there have been many studies published on post-operative implant volume increase could also pro- different aspects of this particular breast implant. This vide a protective influence in developing capsular con- provides us with the opportunity to relate the different tracture. Additionally, implant ruptures led to a higher aspects to factors that influence shell rupture, gel bleed- probability for capsular contracture. We unquestionably ing, and capsular contracture, all of which are compli- encourage more research on the dynamics of breast im- cations regularly occurring in patients with new models plants, particularly with implant models that are current- of breast implants. If we can compare these factors in ly on the market. We also urge official health institu- the PIP implants, and compare the identified factors tions to implement stricter guidelines following Hazard with breast implants that are currently being used, we Analysis and Critical Control Points (HACCP) to ensure will be able to better understand the causes for these a higher quality of breast implants and thus better pa- complications. One major limitation that this scenario tient safety. offers is the lack of a control group. Comparison of Acknowledgements We would like to thank Peter Keizers (PhD, our data with other brands of implants could have pro- National Institute for Public Health and the Environment, Bilthoven, vided a more clinically relevant outcome for our Eur J Plast Surg (2018) 41:563–570 569 The Netherlands) who offered expert advice on the chemical structure and tracture after prosthetic breast reconstruction. Plast Reconstr Surg development of the PIP implants. We would also like to show our grati- 96(5):1124 tude to Martijn Heijmans (PhD, Department of Epidemiology and 11. Spear S, Mesbahi A (2007) Implant-based reconstruction. Clin Plast Biostatistics, VU University Medical Center, Amsterdam, Surg 34(1):63–73 The Netherlands) for his expert advice on statistical analysis. 12. Holmes JD (1989) Capsular contracture after breast reconstruction with tissue expansion. Br J Plast Surg 42(5):591–594 13. Burkhardt (1988) Capsular contracture: hard breasts, soft da- Compliance with ethical standards ta. Clin Plast Surg 15(4):521–532 14. Virden C, Dobke M, Stein P, Parsons L, Frank D (1992) Subclinical Conflict of interest Yara Bachour, Zavira C.M. Heinze, Tobias infection of the silicone breast implant surface as a possible cause of Dormaar, Gijs van Selms, Marco J.P.F. Ritt, and Frank B. Niessen declare capsular contracture. Aesthetic Plast Surg 16(2):173–179 that they have no conflict of interest. 15. 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Journal

European Journal of Plastic SurgerySpringer Journals

Published: Jun 1, 2018

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