Advertisement

The PIP mammary prosthesis: A product recall study

Published:March 14, 2012DOI:https://doi.org/10.1016/j.bjps.2012.02.019

      Summary

      Introduction

      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.

      Patients and methods

      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.

      Results

      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.

      Discussion

      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.

      Keywords

      Introduction

      On March 31st 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning leading to the immediate withdrawal of mammary implants from the French manufacturer, Poly Implant Prothèse (PIP), due to serious concerns about the quality of gel filler.

      MHRA medical device alert MDA/2010/025, issued 31st March 2010.

      Subsequent tests by both the British MHRA

      MHRA medical device alert MDA/2010/78, issued 4th October 2010.

      and French Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

      AFSSAPS medical devices evaluation direction. Silicone based filling gel breast implants from Poly Implant Prothèse Company: update of test results, issued 14th April 2011.

      have fortunately allayed fears of genotoxicity. There has been speculation about an unusually high rupture frequency of PIP’s implants over recent years as recognised recently by AFSSAPS,

      AFSSAPS medical devices evaluation direction. Silicone based filling gel breast implants from Poly Implant Prothèse Company: update of test results, issued 14th April 2011.

      although the equivalent Australian body, the Therapeutic Goods Administration (TGA), did not show this on their supplied samples.

      Therapeutic Goods Administration. PIP implant update, issued 14th July 2010.

      Whilst the senior author had ceased using these devices completely in August 2005 and other independent surgeons had followed suit,
      • Berry R.B.
      Rupture of PIP breast implants.
      many of the ‘cosmetic companies’ had been using PIP implants right up until the ban on account of their favourable cost. Most recently (December 21st 2011), the MHRA had to issue a further alert in response to the publicity surrounding the death from ALCL of a French patient with PIP devices. This same alert stated the rupture rate of PIP prostheses – as measured by reports to the MHRA – to be of the order 1%.
      PIP has had a somewhat chequered history with their earlier Hydrogel implant also withdrawn from the market because of late, inflammatory swelling.

      MHRA DA 2000(07) – breast implants: PIP hydrogel, issued 11th December 2000.

      With regard to PIP’s high cohesive gel implant, loco-regional silicone spread was reported in 2006
      • Lahiri A.
      • Waters R.
      Locoregional silicone spread after high cohesive gel silicone implant rupture.
      and a case of systemic cutaneous dissemination in late 2011.
      • Cawrse N.H.
      • Pickford M.A.
      Cutaneous manifestation of silicone dissemination from a PIP implant – a case for prophylactic explantation?.
      Whilst not considered injurious to health in the long-term,
      • Ahn C.Y.
      • Shaw W.W.
      • Narayanan K.
      • Gorczyca D.P.
      • DeBruhl N.D.
      • Bassett L.W.
      Residual silicone detection using MRI following previous breast implant removal: case reports.
      presentation with either breast masses or palpable lymphadenopathy because of silicone dissemination, adds an additional emotional burden of the spectre of cancer, notwithstanding the extra resources involved in investigating this cancer-prone organ. Albeit rare, idiosyncratic granulomatous reactions requiring aggressive debridement and reconstruction have been reported.
      • Malyon A.D.
      • Dunn R.
      Weiler-Mithoff. Expanding silicone granuloma.
      Whilst placing the present outcomes in perspective, published literature often combines different implant generations,
      • Young V.L.
      • Brandon H.J.
      • Watson M.E.
      Discussion – silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants.
      manufacturers and techniques including cosmetic admixed with reconstructive,
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      • Hedén P.
      • Bronz G.
      • Elberg J.J.
      • et al.
      Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.
      which serve to introduce bias and makes direct comparison difficult. Even device-specific studies generally involve either heterogeneous surgeons and/or techniques
      • Hedén P.
      • Boné B.
      • Murphy D.K.
      • Slicton A.
      • Walker P.S.
      Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.
      • Spear S.L.
      • Murphy D.K.
      • Slicton A.
      • et al.
      Inamed silicone breast implant core study. Results at 6 years.
      • Cunningham B.
      • McCue J.
      Safety and effectiveness of Mentor’s MemoryGel implants at 6 years.
      so the clarity of the outcome may be clouded somewhat. With a single-surgeon, constant-technique cohort of several hundred patients since 2000, we present what is certainly homogeneous and may well be the first independent product recall study of a medical device.

      Patients and methods

      Women were eligible for inclusion in the study on the basis of having undergone breast augmentation with PIP mammary prostheses after January 2000. The senior author had evolved over more than 15 years a standard and reliable technique of trans-axillary, submuscular breast augmentation (TABA). Implant exchange utilised the axillary route except in cases either where rupture had been demonstrated radiologically to avoid silicone contamination of the axilla. An inframammary approach was also used where capsular surgery was anticipated. This took one of two forms: thin, pliable capsules were subjected to capsulotomy. On the other hand, thick, contracted, silicone-impregnated capsular tissue led to capsulectomy.
      A part-time researcher appointed in July 2010 identified all patients who had undergone breast augmentation with PIP implants from January 2000–August 2005. The database constructed contained demographic and implant-specific details. Chief outcome measures included secondary surgery in general, implant integrity and time to rupture. Correlation of imaging at explantation was also evaluated and will be analysed and presented in a separate study. All patients identified were sent an initial letter detailing the MHRA guidance and offering a free, without-obligation, consultation. Non-responders were then approached to optimise the recall by telephone and/or email until all avenues were exhausted. At consultation, the patient’s desire and/or clinical examination dictated further management, but all were encouraged to undergo an ultrasound scan (USS) with a breast-specialist team. Joint BAPRAS (British Association of Plastic Reconstructive and Aesthetic Surgeons) and BAAPS (British Association of Aesthetic Plastic Surgeons) guidance includes the following:
      • all patients being able to have an assessment by a surgeon, whether symptomatic or not
      • implant removal should be undertaken upon patient request and adequate time for reflection should be allowed
      • because radiological scans are not completely reliable, they should only be used as a tool to assist patients’ decision-making
      • advice to general practitioners on where to most appropriately refer patients

      Results

      Between January 2000 and July 2005, 453 consecutive patients underwent primary (209) or secondary (244) breast augmentation with PIP implants. The median age was 38 years (range 18–69) with a median implant volume of 270 cc (range 125–620). Contact could not be made with 180 (39.7%) women and Table 1 summarises the ultimate status of the cohort at time of writing, although follow up and data acquisition continues.
      Table 1Outcomes of patients in the study. ACC=adverse capsular contracture; USS=ultrasound scan.
      Patient outcomeNumberPercent
      Uncontactable18039.7
      Treatment elsewhereNo details132.9
      ≥1 rupture61.3
      Prior explantationRupture102.2
      Elective for size81.8All intact
      ACC71.55 Intact
      Cancer30.72 Intact
      Infection10.2Intact
      Silicone phobia10.2Intact
      No signs, no symptoms: review9721.4
      Imaging and surgery-confirmed rupture388.4
      No concerns, declined review4710.4
      Explanted, no rupture30.7
      AwaitingUSS184
      Implant exchange153.313 USS +ve
      Preg/medical62 USS +ve
      453
      Secondary surgery was undertaken in 42 patients for an overall rate of 9.3% as detailed in Table 2. Whilst the majority underwent a single surgical episode, 5 required additional tertiary procedures including 2 cases of recurrent adverse capsular contracture (ACC) and single instances of haematoma, infection, malposition.
      Table 2Secondary surgery details. ACC=adverse capsular contracture; IMF=infra-mammary fold.
      Secondary surgeryNumber%
      ACC (Baker III/IV)163.5
      Size request81.8
      Haematoma51.1
      InfectionExplantation40.9
      Salvage10.2
      Investigative biopsy30.73 Siliconomata
      IMF-plasty30.7
      Malposition20.4
      429.3
      All patients who underwent surgical exploration had explantation of their PIP devices, copious lavage and capsule surgery as required with replacement using Allergan Natrelle prostheses. Nineteen had already undergone surgical intervention for rupture prior to the study commencement, 13 in the practice and 6 elsewhere. Surgical confirmation of USS-detected rupture was confirmed in 38 patients and there was a single false negative (failure to identify a contralateral rupture in on patient). Three patients underwent replacement of intact prostheses at their own instigation and 21 await implant exchange, 15 of which have USS-confirmed rupture, many of whom are attempting implant exchange through the National Health Service (NHS).

      Discussion

      We are by now well-accustomed to meticulous breast augmentation data from the likes of Tebbetts,
      • Tebbetts J.B.
      Transaxillary subpectoral augmentation mammaplasty: long-term follow-up and refinements.
      Hedèn
      • Hedén P.
      • Jernbeck J.
      • Hober M.
      Breast augmentation with anatomical cohesive gel implants.
      and Handel
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      amongst others, but even these exemplars at times combine techniques, surgeons, implant generations, fillers, surfaces, and aesthetic with reconstructive indications. Although with inherent selection bias, they do, however, provide a benchmark against which to measure the performance of the PIP mammary implant. For single-surgeon, single-device series Brown
      • Brown M.H.
      • Shenker R.
      • Silver S.A.
      Cohesive silicone gel breast implants in aesthetic and reconstructive surgery.
      and Tebbetts’
      • Tebbetts J.B.
      Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval.
      small cohorts have short follow up, but provide the closest comparables to our own cohort.
      With the literature containing a wealth of studies,
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      • Hedén P.
      • Bronz G.
      • Elberg J.J.
      • et al.
      Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.
      • Hedén P.
      • Boné B.
      • Murphy D.K.
      • Slicton A.
      • Walker P.S.
      Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.
      • Spear S.L.
      • Murphy D.K.
      • Slicton A.
      • et al.
      Inamed silicone breast implant core study. Results at 6 years.
      • Cunningham B.
      • McCue J.
      Safety and effectiveness of Mentor’s MemoryGel implants at 6 years.
      • Brown M.H.
      • Shenker R.
      • Silver S.A.
      Cohesive silicone gel breast implants in aesthetic and reconstructive surgery.
      • Tebbetts J.B.
      Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval.
      • Hedén P.
      • Nava M.B.
      • van Tetering J.P.B.
      • et al.
      Prevalence of rupture in Inamed silicone breast implants.
      • Bengston B.P.
      • Van Natta B.W.
      • Murphy D.K.
      • Slicton A.
      • Maxwell G.P.
      Style 410 highly cohesive silicone breast implant core study results at 3 years.
      • Stevens W.G.
      • Pacella S.J.
      • Gear A.J.L.
      • et al.
      Clinical experience with a fourth-generation textured silicone gel breast implant: a review of 1012 Mentor MemoryGel breast implants.
      it is necessary to evaluate the representative, or otherwise, nature of ours. Recent manufacturer-sponsored ‘core’ studies have revealed a secondary surgery rate much higher than hitherto realised, or admitted to, well in excess of 30%.
      • Spear S.L.
      • Murphy D.K.
      • Slicton A.
      • et al.
      Inamed silicone breast implant core study. Results at 6 years.
      • Cunningham B.
      • McCue J.
      Safety and effectiveness of Mentor’s MemoryGel implants at 6 years.
      Other small, single-surgeon studies come in much lower at 0–1.7%, but have relatively short follow up.
      • Brown M.H.
      • Shenker R.
      • Silver S.A.
      Cohesive silicone gel breast implants in aesthetic and reconstructive surgery.
      • Tebbetts J.B.
      Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval.
      With a period of 6–11 years, our study sits somewhere between these extremes and secondary surgery in 9.3% seems not unreasonable. Of note, some of the North American studies have much higher prevalences of adverse capsular contracture (ACC) (circa 20%
      • Spear S.L.
      • Murphy D.K.
      • Slicton A.
      • et al.
      Inamed silicone breast implant core study. Results at 6 years.
      vs. 3.5%) and size change (7.3%
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      vs. 1.8%). The figures presented in this study also validate a technique, TABA, that has fallen out of vogue of late, but is clearly safe, durable and consistent in experienced hands.
      Whilst disappointing that 180 (39.7%) resisted all forms of contact, Handel reported a similar figure, 45.1%, of ‘mail returned, undelivered’ in his landmark 25-year study of breast augmentees.
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      Other reported loss to follow up rates of 14% at 3 years,
      • Bengston B.P.
      • Van Natta B.W.
      • Murphy D.K.
      • Slicton A.
      • Maxwell G.P.
      Style 410 highly cohesive silicone breast implant core study results at 3 years.
      20% at 6 years,
      • Spear S.L.
      • Murphy D.K.
      • Slicton A.
      • et al.
      Inamed silicone breast implant core study. Results at 6 years.
      52% at 8.9 years
      • Collis N.
      • Litherland J.
      • Enion D.
      • Sharpe D.T.
      Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity.
      and 72.4% at 25 years
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      confirm the temporal relationship logically anticipated (Figure 1). As to why even manufacturer-sponsored, and financially-incentivised
      • Spear S.L.
      • Murphy D.K.
      • Slicton A.
      • et al.
      Inamed silicone breast implant core study. Results at 6 years.
      ‘core’ studies should fail to achieve complete surveillance a range of reasons has been offered: undoubtedly youthful age is contributory, but increased individual mobility is another factor.
      • Young V.L.
      • Brandon H.J.
      • Watson M.E.
      Discussion – silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants.
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      Certainly this may have been important in this study as the senior author has both a national and international practice. Women happy with their results have little incentive to return and tend to avoid further follow up as it may remind them of a less appealing earlier self.
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      Whilst we assume that those dissatisfied invariably make it known to their surgeon, there are those who make no complaint and simply seek assistance elsewhere.
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      Ultimately, of the cohort we were able to contact, only 19.3% declined (17.2% with no concerns and 2.1% with other more pressing issues such as pregnancy or malignancy).
      Figure thumbnail gr1
      Figure 1Temporal relationship confirming how loss of follow up increases with time.
      With clinical detection by experienced Plastic Surgeons less than 30% accurate,
      • Hölmich L.R.
      • Fryzek J.P.
      • Kjoller K.
      • et al.
      The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging.
      imaging is required for further investigation of implant rupture. Ultrasound is relatively cheap, rapid and possible in all patients, but magnetic resonance imaging (MRI) is accepted as the method of choice for its higher (91%) specificity.
      • Cher D.J.
      • Conwell J.A.
      • Mandel J.S.
      MRI for detecting silicone breast implant rupture: meta-analysis and implications.
      Interestingly, the true accuracy of MRI has recently been questioned
      • Song J.W.
      • Kim H.M.
      • Bellfi L.T.
      • Chung K.C.
      The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis.
      and both diagnostic tests seem to be most accurate for symptomatic cases, with screening for silent rupture not being as discriminatory as previously believed. Whilst not the prime focus of this study, our figures of only one missed rupture indicate that USS in the hands of a specialist team may allow an high level of confidence, at least with respect to rupture and perhaps the pendulum will swing back towards USS for evaluation of symptomatic rupture. As ever, the ‘gold-standard’ remains surgical explantation so we will continue to follow these patients with interest.
      Whilst also allowing a glimpse into a busy, single-handed practice, this study reiterates some of the difficulties in trying to maintain long-term surveillance of cosmetic patients, particularly the younger generation.
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      Furthermore, with some of the prostheses in situ for 10 years, qualified comment can be made with respect to the longevity/behaviour of a single mammary implant, which, given its textured surface and cohesive gel filler, should be considered a 4th generation device. It also provides, partial, response to the apt criticism of Young et al. who observe that whilst explantation studies have their uses, they usually yield only an absolute number for numerator, albeit one that may be extrapolated,
      • Young V.L.
      • Brandon H.J.
      • Watson M.E.
      Discussion – silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants.
      whereas a cohort such as this one allows both the numerator and denominator to permit a rate calculation. Gratifyingly, rates for implant rupture have shown consistent improvement with a rupture risk estimated at 8–15% for the first decade in 2003.
      • Hölmich L.R.
      • Friis S.
      • Fryzek J.P.
      • et al.
      Incidence of silicone breast implant rupture.
      Table 3 shows both how the modern implant generation has improved, but also the unduly elevated rate of PIP’s device. This has been presented as a range because we are not aware of the precise outcome of all patients. The lowest assumes we have collected all the ruptures and those declining or not responding have intact devices (72 of 453: 15.9%). The highest scales what we have observed throughout the entire cohort (72 of 213: 33.8%). Whilst the adverse publicity may have accentuated the selection bias of those with any signs or symptoms, the actual figure will lie somewhere between the two extremes, but is certainly higher for PIP than its peers (Table 3). Another matter of interest is the MHRA statement of only post-2000 devices being at risk.

      MHRA medical device alert MDA/2010/78, issued 4th October 2010.

      As Figure 4 demonstrates, whilst one might expect greater rupture frequency with time, there is an inverse relationship and durability seems to worsen with younger implant age.
      Table 3Combined literature for common performance indices and rupture rate.
      AuthorYearSample (patients)ImplantSurgeonTechniqueStudy (years)Follow up (%)Reoperation (%)ACC (%)Rupture (%)Core study
      Brown2005118 (1°)Allergan 410SingleMultiple1.751.70.80N
      Hedén200677 (1°)

      18 (2°)
      Allergan 3rd genMultipleMultiple10.942.78N
      Tebbetts200650 (1°)Allergan 410SingleSingle394000Y
      Hedén2006124 (1°)

      20 (2°)
      Allergan 410MultipleMultiple61N
      Handel2006825 (1°)

      NS (2°)
      VariousMultipleMultiple10NS15.5@ 1.1
      Expressed as rate per 1000 patient-months.
      NSN
      Spear2007455 (1°)

      147 (2°)
      Allergan (various)MultipleMultiple6@ 7028

      40.3
      14.8

      20.5
      3.5Y
      Bengston2007492 (1°)

      156 (2°)
      Allergan 410MultipleMultiple3@ 8312.5

      21.1
      1.9

      4.8
      1Y
      Stevens2008181 (1°)

      283 (2°)
      Mentor Memory GelSingleMultiple2.7NS82.60.4N
      Hedén2009112 (1°)Allergan 410MultipleMultiple8NSNS5.3
      Includes reconstruction and revision cases in addition to primary augmentation.
      1.7N
      Cunningham2009552 (1°)

      145 (2°)
      Mentor MemoryGelMultipleNS662.519.4

      34.2
      9.8

      22.4
      1.1

      11.6
      Y
      Present2011453PIPSingleSingle6–1159.89.33.515.9–33.8N
      Key: ACC=adverse capsular contracture; 1°=primary breast augmentation; 2°=revision breast augmentation; NS=not specified.
      a Expressed as rate per 1000 patient-months.
      b Includes reconstruction and revision cases in addition to primary augmentation.
      Although passed fit for purpose through national regulatory bodies and CE (Conformité Européene) marking and used in good faith by surgeons, it now seems that some PIP implants were constructed of sub-optimal materials, including filler silicone intended for mattresses. The elastomer too may have been lacking a fluorinated, anti-bleed lamina. Although common in other industries, with Mercedes’ infamous “Elk-test”, product recalls are both an important aspect of modern manufacturing industry and likely to be very costly in public relation terms if mishandled. This is not vastly dissimilar to our own industry of health provision that has witnessed the incorporation of airline-derived risk analysis and management into clinical governance.
      • Hirst G.
      Surgical training – can we learn from aviation?.
      It is yet further incumbent upon surgeons and other healthcare providers to not only collect data, but to operate proactively as demonstrated by the senior author and others.
      • Berry R.B.
      Rupture of PIP breast implants.
      Both unilaterally desisted using PIP devices due to observing an higher rupture frequency. The senior author had been further disappointed by less than enthusiastic responses from the manufacturer when expressing concerns and returning implants for detailed assessment: Figure 2 being typical of the response to a ruptured device.
      Figure thumbnail gr2
      Figure 2Typical example of the response to request for examination of a suspected defective device.
      Further to the perception of more likely rupture, and naturally all implants will inevitably fail, PIPs’ devices suffered not simply a tear, but catastrophic elastomer disruption (Figure 3a ), often with evidence of chronic gel bleed and a cloudy exudate
      • Cawrse N.H.
      • Pickford M.A.
      Cutaneous manifestation of silicone dissemination from a PIP implant – a case for prophylactic explantation?.
      indicative of silicone peroxidation (Figure 3b) at a relatively early stage. The ‘PIP fiasco’ may become the Trilucent of the current generation: that it results from fraudulent practice rather than poor pre-market product testing, highlights the challenges faced by our present regulatory bodies. As an implantable medical device, breast prostheses are subject to regulations including the 1993 European Medical Devices Directive.

      Council of the European Communities. Council Directive 93/42/EEC of June 1993 concerning medical devices. OJ L169: 1–43. 1993.

      and 2002s national UK law.
      • Great Britain
      The medical devices regulations 2002.
      CE marking is Europe’s highest level of regulation for medical devices, however, it constitutes merely a manufacturer’s declaration that the product complies with the health, safety and environmental requirements of the relevant Product Directive and has no requirement for clinical data submission. It requires notification of adverse incidents, under the ‘vigilance system’, in order to protect the patient and reduce similar incidents occurring elsewhere. Importantly, ‘procedures must exist to both systematically audit post-production experience and implement corrective action such as a product recall’. This clearly failed to happen with PIP implants and one can only lament the disbanding of the National Implant Registry that existed 1993–2006. Perhaps a renascence should be considered, and a central body set up along the lines of the FSA whereby a tithe upon each implant would fund it. In much the same way as consumer items are registered, ‘lifetime’ guarantees currently touted by manufacturers could perhaps be activated only by the patient registering on a relatively cheap website: BAAPS’s recent proposals for an “implant passport”

      BAAPS F Fatah personal communication 4th March 2011.

      should be welcomed and supported by all.
      Figure thumbnail gr3
      Figure 3a: Representative example of a ruptured PIP implant showing not simply a tear in the shell, but catastrophic elastomer disruption. b: cloudy exudate from the explanted device shown in a.
      Figure thumbnail gr4
      Figure 4Temporal rupture rates. =median time to rupture by year (months); =percentage rupture per year.
      In the UK, the legal issue in Britain has been addressed and PRASIS, the specialised indemnity underwriters to BAPRAS-affiliated surgeons, recently clarified the legal position and concluded ‘it is unlikely that surgeons will have liability under the Consumer Protection Act 1987’.

      PIP breast implants. Legal Review 23rd July 2010.

      From a patient perspective the current situation differs with Lipomatrix (parent company of Trilucent implants) underwriting costs for implant exchange. It would appear that PIP executives, however, rapidly placed the company in liquidation, neatly removing this avenue from its patients.
      This study is interesting from a number of perspectives. It is uncommon that such comprehensive, single-surgeon data has been both present, and freely available for 2nd party evaluation, for a cohort of patients that have undergone a standard surgical technique utilising a single-device. Significant advantages of the study include the consecutive sample of patients that have undergone a standardised surgical procedure by a single-surgeon. The process has, however, shown that studies such as this have significant additional costs, which include those of office resources in addition to additional staff. It is neither a study to undertake lightly or to be possible in many practices, particularly in an era of global austerity. The latter is similarly true for both surgeons and their patients, particularly when a small, but sizeable proportion of the cohort lived overseas. It is, however, well worth the efforts from the perspective of acquiring some data, which serves as an useful basis for discussion with patients, most of whom are concerned from a dual safety and additional financial aspect. Moreover, a plaintive tone was surprisingly rare with those expressing their surprised appreciation and gratitude at the efforts made to contact them greatly outweighing any negative response. It is acknowledged that the reported study has inherent limitations, particularly with respect to inclusion bias as previously noted.
      • Handel N.
      • Cordray T.
      • Gutierrez J.
      • et al.
      A long-term study of outcomes, complications, and patient satisfaction with breast implants.
      Finally, recent publicity has surrounded a single case of mortality from ALCL in a patient with PIP implants. ALCL is a rare lymphoma that has been reported in association with silicone breast implants the current significance of which is unclear. Despite media speculation its occurrence has been found to be lower than expected in those with breast implants in the Allergan multi-centre trial.
      • Spear S.L.
      • Largent J.
      • Kaplowitz H.
      • et al.
      Occurrence of anaplastic large cell lymphoma (ALCL) among large multi-centre prospective clinical studies of breast implant patients.
      Furthermore, a systematic review seems to suggest that implant-associated ALCL may follow a less aggressive course.
      • Kim B.
      • Roth C.
      • Chung K.C.
      • et al.
      Anaplastic large cell lymphoma and breast implants: a systematic review.
      Although small, it is encouraging that no cases of ALCL have been diagnosed in our cohort, but surveillance will be continued. It deserves mention that this study does not, in fact cannot at this stage, comment upon the consequences of non-medical grade silicone in close approximation to human breast tissue.

      Conclusion

      This study contributes several useful things. Firstly, it demonstrates that practice-based, procedure-specific recall is possible, if challenging in terms of time and other resources. Secondly, it provides the first evidence base, about what we now know to be a defective breast implant and which we can use to guide management of concerned patients with PIP implants. In common with both manufacturer-sponsored surveillance and international centre-based studies, we reiterate that the demographic and mobility of breast augmentees predisposes to less than perfect follow up. Finally, it shows that the PIP implant has a rupture rate disproportionately higher than equivalent devices and reawakens the debate for a more robust implant registry than a system of voluntary reporting.

      Acknowledgements

      The authors express their sincere appreciation to the administrative staff at Surgical Aesthetics, particularly Ashleigh and Janice, without whose efforts the study would not have been possible.
      Neither author has any additional financial or corporate affiliations to disclose.

      References

      1. MHRA medical device alert MDA/2010/025, issued 31st March 2010.

      2. MHRA medical device alert MDA/2010/78, issued 4th October 2010.

      3. AFSSAPS medical devices evaluation direction. Silicone based filling gel breast implants from Poly Implant Prothèse Company: update of test results, issued 14th April 2011.

      4. Therapeutic Goods Administration. PIP implant update, issued 14th July 2010.

        • Berry R.B.
        Rupture of PIP breast implants.
        J Plast Reconstr Aesthet Surg. 2007; 60: 967-968
      5. http://www.mhra.gov.uk/NewsCentre/CON137888. [accessed 30.12.11].

      6. MHRA DA 2000(07) – breast implants: PIP hydrogel, issued 11th December 2000.

        • Lahiri A.
        • Waters R.
        Locoregional silicone spread after high cohesive gel silicone implant rupture.
        J Plast Reconstr Aesthet Surg. 2006; 59: 885-886
        • Cawrse N.H.
        • Pickford M.A.
        Cutaneous manifestation of silicone dissemination from a PIP implant – a case for prophylactic explantation?.
        J Plast Reconstr Aesthet Surg. 2011; 64: e208-e209
        • Ahn C.Y.
        • Shaw W.W.
        • Narayanan K.
        • Gorczyca D.P.
        • DeBruhl N.D.
        • Bassett L.W.
        Residual silicone detection using MRI following previous breast implant removal: case reports.
        Aesthet Plast Surg. 1995; 19: 361-367
        • Malyon A.D.
        • Dunn R.
        Weiler-Mithoff. Expanding silicone granuloma.
        Br J Plast Surg. 2001; 54: 257-259
        • Young V.L.
        • Brandon H.J.
        • Watson M.E.
        Discussion – silicone gel-filled breast implant integrity: a retrospective review of 478 consecutively explanted implants.
        Plast Reconstr Surg. 1999; 105: 1986-1989
        • Handel N.
        • Cordray T.
        • Gutierrez J.
        • et al.
        A long-term study of outcomes, complications, and patient satisfaction with breast implants.
        Plast Reconstr Surg. 2006; 117: 757-767
        • Hedén P.
        • Bronz G.
        • Elberg J.J.
        • et al.
        Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.
        Aesth Plast Surg. 2009; 33: 430-436
        • Hedén P.
        • Boné B.
        • Murphy D.K.
        • Slicton A.
        • Walker P.S.
        Style 410 cohesive silicone breast implants: safety and effectiveness at 5 to 9 years after implantation.
        Plas Reconstr Surg. 2006; 118: 1281-1287
        • Spear S.L.
        • Murphy D.K.
        • Slicton A.
        • et al.
        Inamed silicone breast implant core study. Results at 6 years.
        Plast Reconstr Surg. 2007; 120: 8S-16S
        • Cunningham B.
        • McCue J.
        Safety and effectiveness of Mentor’s MemoryGel implants at 6 years.
        Aesth Plast Surg. 2009; 33: 440-444
      7. http://www.baaps.org.uk/about-us/press-releases/707-latest-developments-on-pip-implants-controversy. Press release 18th June 2010, [accessed 30.12.11].

        • Tebbetts J.B.
        Transaxillary subpectoral augmentation mammaplasty: long-term follow-up and refinements.
        Plast Reconstr Surg. 1984; 74: 636-649
        • Hedén P.
        • Jernbeck J.
        • Hober M.
        Breast augmentation with anatomical cohesive gel implants.
        Clin Plast Surg. 2001; 28: 531-552
        • Brown M.H.
        • Shenker R.
        • Silver S.A.
        Cohesive silicone gel breast implants in aesthetic and reconstructive surgery.
        Plast Reconstr Surg. 2005; 116: 768-779
        • Tebbetts J.B.
        Achieving a zero percent reoperation rate at 3 years in a 50-consecutive-case augmentation mammaplasty premarket approval.
        Plast Reconstr Surg. 2006; 118: 1453-1457
        • Hedén P.
        • Nava M.B.
        • van Tetering J.P.B.
        • et al.
        Prevalence of rupture in Inamed silicone breast implants.
        Plast Reconstr Surg. 2006; 118: 303-308
        • Bengston B.P.
        • Van Natta B.W.
        • Murphy D.K.
        • Slicton A.
        • Maxwell G.P.
        Style 410 highly cohesive silicone breast implant core study results at 3 years.
        Plast Reconstr Surg. 2007; 120: 40s-48S
        • Stevens W.G.
        • Pacella S.J.
        • Gear A.J.L.
        • et al.
        Clinical experience with a fourth-generation textured silicone gel breast implant: a review of 1012 Mentor MemoryGel breast implants.
        Aesthetic Surg J. 2008; 28: 642-647
        • Collis N.
        • Litherland J.
        • Enion D.
        • Sharpe D.T.
        Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity.
        Plast Reconstr Surg. 2007; 120: 1401-1406
        • Hölmich L.R.
        • Fryzek J.P.
        • Kjoller K.
        • et al.
        The diagnosis of silicone breast-implant rupture: clinical findings compared with findings at magnetic resonance imaging.
        Ann Plast Surg. 2005; 54: 583-589
        • Cher D.J.
        • Conwell J.A.
        • Mandel J.S.
        MRI for detecting silicone breast implant rupture: meta-analysis and implications.
        Ann Plast Surg. 2001; 47: 367-380
        • Song J.W.
        • Kim H.M.
        • Bellfi L.T.
        • Chung K.C.
        The effect of study design biases on the diagnostic accuracy of magnetic resonance imaging for detecting silicone breast implant ruptures: a meta-analysis.
        Plast Reconstr Surg. 2011; 127: 1029-1044
        • Hölmich L.R.
        • Friis S.
        • Fryzek J.P.
        • et al.
        Incidence of silicone breast implant rupture.
        Arch Surg. 2003; 138: 801-806
      8. http://www.nytimes.com/1997/12/11/business/mercedes-benz-tries-to-put-a-persistent-moose-problem-to-rest.html. [accessed 28.11.11].

        • Hirst G.
        Surgical training – can we learn from aviation?.
        Ann R Coll Surg Engl (Suppl). 2006; 88: 48-51
      9. Council of the European Communities. Council Directive 93/42/EEC of June 1993 concerning medical devices. OJ L169: 1–43. 1993.

        • Great Britain
        The medical devices regulations 2002.
        (SI 2002 No. 618)0110423178 HMSO, London2002
      10. BAAPS F Fatah personal communication 4th March 2011.

      11. PIP breast implants. Legal Review 23rd July 2010.

        • Spear S.L.
        • Largent J.
        • Kaplowitz H.
        • et al.
        Occurrence of anaplastic large cell lymphoma (ALCL) among large multi-centre prospective clinical studies of breast implant patients.
        Plast Reconstr Surg. 2010; 126: 68
        • Kim B.
        • Roth C.
        • Chung K.C.
        • et al.
        Anaplastic large cell lymphoma and breast implants: a systematic review.
        Plast Reconstr Surg. 2011; 127: 2141-2150