Poly Implant Prothèse Implants Research Articles

History of the Australian Breast Device Registry

Following the Dow Corning crisis in the 1990s, several national breast implant registries were formed by plastic surgery societies around the world. The Australian Breast Implant Registry (BIR) was developed in 1997 as a voluntary registry where patients were charged a moiety per implant. At the time of the Poly Implant Prothèse (PIP) crisis in 2010, there were over 30,000 registrations in the BIR. However, when the dataset was interrogated to retrieve PIP implant-related information, only 3.4 per cent of 13,000 PIP implants were recorded in the BIR database.

Biomechanical analysis of intact versus ruptured Poly Implant Prothèse breast implants.

Despite there being many studies that have evaluated breast implant rupture, there is no consensus about causes and incidence. Most studies lack a multifactorial analysis of what causes breast implants to rupture. To fill this gap, an experimental protocol was developed to compare ruptured and intact Poly Implant Prothèse (PIP) breast implants from the same woman. These conditions guarantee that the physical/biological variables are the same for each pair of ruptured and intact implants. A total of 1008 samples from 22 PIP explants (11 intact and 11 ruptured) and three control PIP implants were analysed. The mechanical properties (tensile strength) of the ruptured and intact implants were compared according to brand, lot, implantation time and demographic conditions. In general, statistically significant differences were found between the intact and ruptured PIP implants. Ruptured implants were thinner (0.73 ± 0.10 mm versus 0.91 ± 0.11 mm) and weaker (7.42 ± 2.65 MPa versus 9.59 ± 2.37 MPa) than intact implants. Intact and ruptured implants have shown distinct mechanical behaviours and variations in thickness. Our understanding is that these differences may be associated with the typical manufacturing process of breast implant shells. These results stress the importance of thorough control of the shell thickness. Given its relevance, shell thickness should be used as a quality control measure for homologation purposes. Thus, the homogeneity of the shell should be considered as a relevant parameter during the manufacturing process. This will translate into an improved quality of life for patients and will potentiate safer and longer lasting products.

Poly Implant Prothèse Silicone Breast Explants: Chemical Analysis of Silicone Gel and Implant Shell

Background:Poly Implant Prothèse (PIP) silicone breast implants were removed from the market between 2010 and 2012 because of the use of nonmedical grade silicone filler. The chemical and physico-chemical properties of PIP implants have been analyzed by several groups. In addition, our previous study illustrated that PIP implant shells were more permeable. Therefore, we analyzed the chemical composition of the envelope and gel of PIP silicone breast explants. Also, the composition of absorbed material into the implant was analyzed.Methods:This study was conducted on 3 PIP implants explanted from 2 patients. The envelope was analyzed using Raman microscopy, whereas the gel was analyzed using near-infrared spectra, nuclear magnetic resonance spectroscopy, and gas chromatography coupled to mass spectrometry. Absorbed material was investigated with Fourier-transform infrared spectroscopy and sodium dodecyl sulfate polyacrylamide gel electrophoresis.Results:The 3 implants appeared to be Rofil implants, and all implants displayed a yellow color. None of the envelope showed a barrier layer. Amounts of D4, D5, and D6 were found to be below 100 ppm. Water was found in all 3 implants and also proteins were absorbed into the implants.Conclusions:The current study shows that the analyzed implants originate from the manufacturer Rofil but have PIP1 hallmarks. Apparently, these are own brand labeling implants. The presence of water and proteins in the explants indicate exchange of small and large molecules into the explants, even in the implant with a visually intact envelope. Because of the PIP1 hallmarks of the Rofil implants, patients with such implants are advised to be counseled by their physicians.

Abstract P2-14-07: A systematic review of the clinical evidence regarding PIP breast implants

Abstract Background: Mammary implants marketed by Poly Implant Prothèse (PIP) were found to contain industrial grade silicone and this caused heightened anxiety and extensive publicity regarding their safety in humans. These implants were used in a large number of patients worldwide for augmentation or breast reconstruction. Methods: Articles were identified by searches of Medline, PubMed, Embase and Google Scholar databases up to March 2014 using the terms: "PIP", "Poly Implant Prothèse","breast implants" and "augmentation mammoplasty" or "silicone" In addition the websites of regulating bodies in Europe, USA and Australia were searched for reports related to PIP mammary implants. Results: PIP mammary implants are more likely to rupture than other implants and can cause adverse effects in the short to the medium term related to the symptoms of rupture such as pain, lumps in the breast and axilla and anxiety. Based on peer-reviewed published studies we have calculated an overall rupture rate of 14.5% (383/2635) for PIP implants. Conclusions: There is no evidence that PIP implant rupture causes long-term adverse health effects in humans so far. The long-term adverse effects usually arise from inappropriate extensive surgery, such as axillary lymph node dissection or extensive resection of breast tissue due to silicone leakage. Citation Format: Umar Wazir, Abdul Kasem, Kefah Mokbel. A systematic review of the clinical evidence regarding PIP breast implants [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-14-07.

Comparison of the Explantation Rate of Poly Implant Prothèse, Allergan, and Pérouse Silicone Breast Implants within the First Four Years after Reconstructive Surgery before the Poly Implant Prothèse Alert by the French Regulatory Authority.

Background. In March 2010, ANSM (Agence Nationale de Sécurité du Medicament), the French Medical Regulatory Authority, withdrew Poly Implant Prothèse (PIP) breast implants from the market due to the use of non-medical-grade silicone gel. The aim of this study was to compare the removal rate (and reasons thereof) of breast implants produced by different manufacturers before the ANSM alert. Materials and Methods. From October 2006 to January 2010, 652 women received 944 implants after breast cancer surgery at the Gustave Roussy Comprehensive Cancer Center, Paris (France). The complications and removal rates of the different implant brands used (PIP, Allergan, and Pérouse) were evaluated and compared. Results. PIP implants represented 50.6% of the used implants, Allergan 33.4%, and Pérouse 16%. The main reasons for implant removal were patient dissatisfaction due to aesthetic problems (43.2%), infection (22.2%), and capsular contracture (13.6%). Two years after implantation, 82% of Pérouse implants, 79% of PIP, and 79% of Allergan were still in situ. There was no difference in removal rate among implant brands. Conclusion. Before the ANSM alert concerning the higher rupture rate of PIP breast implants, our implant removal rate did not predict PIP implant failure related to the use of nonapproved silicone gel.

The clinical implications of poly implant prothèse breast implants: an overview.

Mammary implants marketed by Poly Implant Prothèse (PIP) were found to contain industrial grade silicone and this caused heightened anxiety and extensive publicity regarding their safety in humans. These implants were used in a large number of patients worldwide for augmentation or breast reconstruction. We reviewed articles identified by searches of Medline, PubMed, Embase, and Google Scholar databases up to May 2014 using the terms: "PIP", "Poly Implant Prothèse", "breast implants" and "augmentation mammoplasty" "siloxanes" or "silicone". In addition the websites of regulating bodies in Europe, USA, and Australia were searched for reports related to PIP mammary implants. PIP mammary implants are more likely to rupture than other implants and can cause adverse effects in the short to the medium term related to the symptoms of rupture such as pain, lumps in the breast and axilla and anxiety. Based on peer-reviewed published studies we have calculated an overall rupture rate of 14.5% (383/2,635) for PIP implants. However, there is no evidence that PIP implant rupture causes long-term adverse health effects in humans so far. Silicone lymphadenopathy represents a foreign body reaction and should be treated conservatively. The long-term adverse effects usually arise from inappropriate extensive surgery, such as axillary lymph node dissection or extensive resection of breast tissue due to silicone leakage.

Poly Implant Prothèse (PIP) incidence of rupture: a retrospective MR analysis in 64 patients.

The purpose of this retrospective study was to describe the magnetic resonance imaging (MRI) features of Poly Implant Prothèse (PIP) hydrogel implants in a group of 64 patients and to assess the incidence of rupture, compared to other clinical trials. In this double-center study, we retrospectively reviewed the data sets of 64 consecutive patients (mean age, 43±9 years, age range, 27-65 years), who underwent breast MRI examinations, between January 2008 and October 2013, with suspected implant rupture on the basis of clinical assessment or after conventional imaging examination (either mammography or ultrasound). All patients had undergone breast operation with bilateral textured cohesive gel PIP implant insertion for aesthetic reasons. The mean time after operation was 8 years (range, 6-14 years). No patients reported history of direct trauma to their implants. At the time of clinical examination, 41 patients were asymptomatic, 16 complained of breast tenderness and 7 had clinical evidence of rupture. Normal findings were observed in 15 patients. In 26 patients there were signs of mild collapse, with associated not significant peri-capsular fluid collections and no evidence of implant rupture; in 23 patients there was suggestion of implant rupture, according to breast MRI leading to an indication for surgery. In particular, 14 patients showed intra-capsular rupture, with associated evidence of the linguine sign in all cases; the keyhole sign and the droplet signs were observed in 6 cases. In 9 patients there was evidence of extra-capsular rupture, with presence of axillary collections (siliconomas) in 7 cases and peri-prosthetic and mediastinal cavity siliconomas, in 5 cases. The results of this double center retrospective study, confirm the higher incidence (36%) of prosthesis rupture observed with the PIP implants, compared to other breast implants.

Analytical investigations on elastomeric shells of new Poly Implant Prothèse (PIP) breast and from sixteen cases of surgical explantation

In this study we have analysed the chemical composition of the extractable components from the elastomeric shells from n=27 explanted implants (n=16 patients), n=2 new PIP implants, and from explanted Eurosilicone and McGhan implants (n=2 for each brand). Empty elastomeric PIP shells (n=2) were also available for analysis.Prostheses were explanted between 2011 and 2012, after 3–11 years of implantation. Patients presented pre- and post-operation complications of different degrees. First we evaluated the micro-structural features of the shells by phase contrast microscopy, and compared the results with those obtained using attenuated total reflectance infrared spectroscopy (ATR-FT-IR), head space gas chromatography coupled to mass spectrometry (HS-GC–MS) and GC–MS in direct injection mode.The results of these studies confirm and explain the conclusion of previous international investigations that evidenced a linear decrease of rupture rate for prostheses implanted after 2006. The analytical identification of a series of UV sensitive radical photo-initiators (0.1%–0.2% w/w), belonging to the benzophenone family, in the shells of new and explanted prostheses produced after 2006 (associated with a strong smell absent in those produced earlier), in parallel to (ii) the removal of the anti bleed barrier from their manufacturing procedure (introduced after 2001), strongly suggested that from 2007, the PIP company used a polymerisation process different from that declared, probably as a consequence of the first reports of rupture problems. In addition, the HS-GC–MS experiments demonstrated that at body temperature the diffusivity of low molecular weight (LMW) silicones present in the PIP filler silicone is significantly higher than that of LMW silicones in an approved implant.

Recall management of patients with Rofil Medical breast implants

Some Rofil Medical breast implants are relabelled Poly Implant Prothèse (PIP) implants, and it is recommended that Rofil implants be managed in the same way as PIP implants. We report the results of a systematic recall of patients who had received Rofil implants. All patients who received Rofil implants at our centre were identified and invited for specialist consultation. In patients who opted for explantation, preoperative and intraoperative work-up was performed in accordance with national guidelines and analysed. In cases suspicious for rupture, an MRI scan was performed. Two-hundred and twenty-five patients (average age 56; range 28-80) received a total of 321 Rofil implants an average of 5.8 (range 1-11) years previously, 225/321 (70%) implants were used for reconstruction after breast cancer. A total of 43 implants were removed prior to 2011, mainly due to capsular contracture (CC). A total of 188 patients were still affected at the time of recall. Of the 188 patients, 115 (61%) attended for specialist consultation, of which 50 (44%) requested immediate implant removal. To date, 72 of 115 (63%) women attending consultation (38% of all affected) have chosen explantation, 66 of 72 (92%) opting for new implants. Of the 108 explanted implants, 25 (23%) had capsular rupture and 57 (53%) had implant bleeding. Preoperative clinical assessment was unreliable for predicting CC or rupture. The majority of patients attended for consultation and requested explantation. The quality of the explanted Rofil implants was comparable to PIP implants, with a higher rupture prevalence compared with other, non-affected implants. Nevertheless, the acceptance of breast implants for reimplantation remained high.

MRI screening for silicone breast implant rupture: accuracy, inter- and intraobserver variability using explantation results as reference standard

The recall of Poly Implant Prothèse (PIP) silicone breast implants in 2010 resulted in large numbers of asymptomatic women with implants who underwent magnetic resonance imaging (MRI) screening. This study's aim was to assess the accuracy and interobserver variability of MRI screening in the detection of rupture and extracapsular silicone leakage. A prospective study included 107 women with 214 PIP implants who underwent explantation preceded by MRI. In 2013, two radiologists blinded for previous MRI findings or outcome at surgery, independently re-evaluated all MRI examinations. A structured protocol described the MRI findings. The ex vivo findings served as reference standard. In 208 of the 214 explanted prostheses, radiologists agreed independently about the condition of the implants. In five of the six cases they disagreed (2.6 %), but subsequently reached consensus. A sensitivity of 93 %, specificity of 93 %, positive predictive value of 77 % and negative predictive value of 98 % was found. The interobserver agreement was excellent (kappa value of 0.92). MRI has a high accuracy in diagnosing rupture in silicone breast implants. Considering the high kappa value of interobserver agreement, MRI appears to be a consistent diagnostic test. A simple, uniform classification, may improve communication between radiologist and plastic surgeon. MRI has a high accuracy in diagnosing rupture in silicone breast implants. MRI appears to be a consistent diagnostic test with excellent interobserver agreement. A simple, uniform classification system, improves communication between radiologist and plastic surgeon. The interobserver agreement on implant rupture is higher than on extracapsular leakage.

Poly Implant Prothèse (PIP) Incidence of Device Failure and Capsular Contracture: A Retrospective Comparative Analysis

The Medicine and Healthcare Products Regulatory Agency in the United Kingdom issued a Medical Device Alert (MDA/2010/025) through a press release on 31 March 2010 for clinicians not to use the Poly Implant Prothèse (PIP) implant. Data were collected to analyze PIP and non-PIP implant failures as well as rates of capsular contracture between August 2008 and August 2012. Relevant data were retrieved for 143 patients with PIP (group A) and non-PIP (group B) implants. Group A (PIP): A total of 65 patients had PIP implants removed. The mean patient age was 37.1 ± 8.1 years (range 24-53 years). The mean duration of the implant was 7.2 ± 2.5 years (range 2-12 years), and the mean preoperative implant size was 327.1 ± 69.6 ml (range 255-495 ml). Of the implants in 65 patients, 18 (27.7 %) were damaged, and of the 64 patients with recorded capsular contractures, 16 (25 %) presented with grades 3 and 4 capsular contractures. Group B (non-PIP): A total of 79 patients had non-PIP implants removed. The mean patient age was 34.4 ± 8.0 years (range 19-54 years). The mean implantation time was 5.8 ± 3.9 years (range 0.2-26 years), and the mean preoperative implant size was 348.2 ± 79.0 ml (range 175-555 ml). Of the 79 patients, 6 had ruptured implants (7.6 %) and 21 (26.6 %) presented with grades 3 and 4 capsular contractures. There were no statistically significant differences in mean patient age (p = 0.046), preoperative size of the implants (p = 0.095), duration of the implantation (p = 0.08), or grades 3 and 4 capsular contractures (p = 0.830). The incidence of implant rupture was significantly higher with the PIP implants than with the non-PIP implants (p = 0.01). The PIP implants were more prone to rupture than the other implants, although the incidence of clinical capsular contracture (grades 3 and 4) was not increased.

Chemical and biochemical composition of late periprosthetic fluids from women after explantation of ruptured Poly Implant Prothèse (PIP) breast prostheses

In this study we have analysed the chemical composition of the silicone extracted from two explanted intact PIP breast prostheses and of breast late periprosthetic fluid (LPF) samples from n=4 patients with ruptured PIP implants.The results obtained by ATR-FT-IR spectroscopy, GC–MS, reverse phase HPLC-UV/DAD, SEC-UV/DAD and contrast phase microscopy demonstrated for the first time that the cloudy, viscous LPF found in the breast of women carriers of PIP implants is a multiphasic amphiphilic silicone/serum microemulsion that can migrate through the body (via lymphatic system) to accumulate first in the lymph nodes. The GC–MS and ATR-FT-IR data indicate that low and high molecular weight silicones (chemical markers: D4–D9, L8) can penetrate the elastomeric shell and periprosthetic capsule and enter the breast tissue via the periprosthetic fluid. Also serum influx from breast tissue into via periprosthetic fluid through the capsule and shell into implant filler silicone (chemical markers: cholesterol by GC–MS, and uric acid, globulins and albumin by HPLC-DAD).To the best of our knowledge, the profile of the major constituents in PIP-induced LPF have been unequivocally characterised for the first time in this work. Further studies will be needed to evaluate the biological consequences of the current results. The potential toxicological implications of the results are discussed in the light of the current literature on the health effects of PIP implants.

The PIP mammary prosthesis: A product recall study

Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothèse (PIP) have been expressed for several years prior to their formal withdrawal from the market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer and the filler gel. Media speculation has focussed on device safety, longevity and, recently, a possible association with lymphoma, specifically anaplastic large cell lymphoma (ALCL). There is however, no actual data concerning these implants with which to guide and inform when concerned patients seek advice. PIP mammary prostheses were used by the senior author for both primary and revision breast augmentation (BA) during the period January 2000-August 2005. A database of patients was constructed and attempts made to contact each patient offering a free consultation and referral for ultrasound scan (USS). Chief outcome measures included secondary surgery, the implant rupture rate and time to rupture. 453 consecutive patients with PIP devices were identified. Of this number 30 had already undergone implant exchange for a variety of reasons. 180 (39.7%) could not be contacted and 19 had undergone explantation elsewhere, including the NHS. Of those who could be contacted, 47 declined consultation as they had no concerns. 97 had neither clinical signs nor radiographic evidence of implant rupture and elected to remain under regular review. At the time of writing, 38 have undergone implant exchange after ultrasonographic indication of rupture and the overall patient rupture rate for the PIP implant is 15.9-33.8%. This cohort correlates reduced implant longevity with each successive year from 2000 and no cases of ALCL have been diagnosed. Long-term studies such as this are difficult to undertake for a number of reasons as they place a significant additional burden of resources on a practice. They are, however, essential from an industry perspective both for the provision of information and supporting audit and professional standing. Being only a single-handed practice, this initial study is the tip of an iceberg that may affect 40,000 women in the UK with PIP implants, but it does provide some hard data with which to guide our patients. It is also believed to be the first independent product recall study in aesthetic breast surgery.

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