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Reply

2012; Lippincott Williams & Wilkins; Volume: 131; Issue: 1 Linguagem: Inglês

10.1097/prs.0b013e318272a119

1529-4242

Maria C. Maijers, Frank B. Niessen,

Reconstructive Surgery and Microvascular Techniques

Sir:FigureWe have read the letter by Berry and Stanek with great interest and are very pleased to learn that more study groups and private plastic surgeon clinics in Europe have taken up the responsibility of objectively providing data on prevalence and clinical consequences of the recalled silicone implants of the French manufacturer Poly Implant Prothèse. Berry and Stanek are to be congratulated, especially after the discussion in Britain which suggested that the majority of the British private sector was disappointingly failing to take responsibility in follow-up and costs in this Poly Implant Prothèse debacle.1,2 Although on some points the two studies3,4 could be called complementary as Berry and Stanek suggest, there are some significant differences we would like to point out and some questions asked we would like to answer. The prevalence of rupture in silicone implants has been a difficult subject to investigate and to objectify and has been a subject of debate over the last decades.5 As we admit that case reports alone do not show a higher prevalence of rupture as such, they were in fact the first and only published concerns of colleagues that led to the surveillance and investigations of this specific brand and French manufacturer in 2009. Although from 2002 onward, surgeons at our own clinic had already decided not to use Poly Implant Prothèse implants anymore for the same reasons the senior author of the series of Berry abandoned this brand 3 years later, no studies or publications have followed to address the quality concerns about Poly Implant Prothèse implants, until the recall in 2010. The disintegration, however, shown in Figure 1 is not specific for a ruptured Poly Implant Prothèse implant but, in our experience, is also seen in silicone implants of other brands. Our study does come to similar conclusions as the study of Berry, which makes the prevalence of rupture in Poly Implant Prothèse implants even more likely to be close to our findings. The study design, however, is significantly different. Berry and Stanek have focused on the whereabouts and secondary surgery outcomes of 453 patients who underwent implantation with Poly Implant Prothèse implants from 2000 to 2005. Their study is more a descriptive study of known medical history data on these women than a study cohort with the aim of studying the prevalence of rupture and clinical consequences, as our own study is. From their article, it remains unclear how many women exactly had symptoms, underwent physical examination and ultrasound screening to determine ruptured implants status, how many implants were ruptured, and whether or not there was extracapsular leakage. Despite a few exceptions in the literature, magnetic resonance imaging is well accepted to be the criterion standard for detecting silicone implant rupture or silicone bleed, especially when looking for “silent” ruptures.6–8 Our study showed that most Poly Implant Prothèse implant ruptures were in fact asymptomatic intracapsular ruptures. However, some have questioned lately the specificity, and we also found a lower specificity of magnetic resonance screening as discussed in our latest publication. The rationale for using ultrasound screening instead of magnetic resonance imaging screening is an understandable and economical decision, but it now remains difficult to compare Berry and Stanek's results to magnetic resonance screening rupture prevalence studies. The calculation of prevalence in Berry and Stanek's cohort remains a wide assumption and is therefore presented by Berry and Stanek as a range between 15.9 (when all unknown status patients would have no ruptured implants) and 33.8 percent (when the known status patients in the cohort are representative of the whole population). We would like to correct Berry and Stanek in the assumption that the worst scenario would be if the group is representative of the population as a whole. The worst would of course be when all nonattenders and decliners would also have had ruptured implants, either silently or already explanted in other clinics. Thus, if Berry and Stanek would follow their own logic, they would have to present an even greater range. As we decided to offer all our women physical examination and magnetic resonance screening and had no decliners, we were able to have strong data on rupture status of both implants of all included women. We believe the group presented therefore is a good representation of the total group of contacted women and the 24 percent prevalence of rupture in Poly Implant Prothèse implants 10 years after implantation time a good estimate of the real prevalence (Table 1).Table 1: Corrected Table 2: Comparison of the Two StudiesLike Berry and Stanek, we had the problem of contacting all women with Poly Implant Prothèse implants, as our follow-up was at least 10 years, in contrast to the 6- to 11-year follow-up of Berry and Stanek. Of course, the same phenomenon occurred in our ongoing study as in their practice, and since our publication more women have come forward for follow-up and data are still being collected. Therefore, this media frenzy mentioned by Berry and Stanek did lead to a more recent higher follow-up percentage but also introduced a new sort of bias, in which patients present with other symptoms than before. We will document this phenomenon and the clinical and diagnostic consequences of Poly Implant Prothèse implants in our next publication. The fact that silicone breast implants become progressively less durable is news as old as silicone rupture studies and is not typical for Poly Implant Prothèse implants as such. Figure 3 in our opinion therefore sheds no new light on the discussion. In Figure 2, Berry and Stanek conclude that the median time to rupture would decline according to implantation year. We would like to remind the authors of the fact that their follow-up time of the implants from 2005 is significantly shorter than that for the implants implanted in 2000. As in our study, the exact timing of rupture is impossible to identify in a retrospective study—the implants from 2000 could have just as easily ruptured in 2005, as most ruptures have proven to be silent ones. Therefore, the conclusion that batches from different years would be of different quality is unjust and also not in line with the National Health Service report, which concluded that there is no significant variation between batches.9 All implantations in 2000 and 2001 were performed in the Jan van Goyen clinic by five different surgeons, all using the same technique through an inframammary incision, a technique still routinely used in Dutch clinics. The position was subglandular in 93 percent, and no differences in rupture prevalence were found between subglandular and submuscular positions. Our study is representative for a common Dutch private clinic and will be more comparable to other private practices and to previously published literature on prevalence, as Berry and Stanek noticed also. We believe that in fact a one-surgeon series has a greater chance of being biased toward a certain technique and professional expertise, which could result in either a more positive or a more negative view of the real prevalence of rupture. The regulators' original advice struck us as illogical too, which was exactly the reason why we decided to also recall the implants from 2000, and we are glad that eventually Jean-Claude Mas admitted to the use of the unauthorized gel also before 2001. This was as Berry and Stanek presume after our publication was accepted on February 6, 10 days before their own publication. The aim of our study was to give timely, clear, uncomplicated data from the daily practice of a typical Dutch private clinic that unfortunately happens to have used the feared Poly Implant Prothèse implants for 2 years in 2000 and 2001. We did not aim to be the first independent product recall study in aesthetic breast surgery or even the first independent product study of a medical device but learned from Berry and Stanek that in fact we are. Maria C. Maijers, M.D. Franciscus B. Niessen, M.D., Ph.D. VU Medical Center, Amsterdam, The Netherlands DISCLOSURE The authors have no financial interest to declare in any of the products or devices mentioned in this communication or in the article it relates to.