Advertisement

Leakage and osmotic shifts in PIP Hydrogel® implants. A case demonstrating increase and decrease of implant volume in the same patient

      Dear Sir,
      Hydrogel® breast implants contain hydroxypropyl cellulose polysaccaride gel. After introduction to the UK market in 1994 approximately 4000 women in the UK received them. Despite withdrawal from the UK market in December 2000 because of inadequate preclinical testing of the metabolic fate of the filling material,
      • Adams T.S.T.
      • Crook T.
      • Cadier M.
      A late complication following the insertion of hydrogel breast implants.
      Hydrogel breast implants withdrawn.
      the current MHRA recommendation is not to routinely explant these implants unless there are problems experienced.
      Hydrogel breast implants withdrawn.
      Formation of a significant fluid collection around Hydrogel® implants
      • Adams T.S.T.
      • Crook T.
      • Cadier M.
      A late complication following the insertion of hydrogel breast implants.
      and the swelling of Hydrogel® implants in vivo have previously been reported and termed ‘Osmotic Instability’.
      • Berthe J.V.
      • Van Gertruyden J.P.
      Osmotic instability of hydrogel-filled breast implants.
      We report bilateral PIP (Poly Implant Prosthesis) Hydrogel® implants with a different complication on each side of the patient resulting in asymmetry. The implant on one side had apparently significantly increased in volume with rupture and a very large fluid collection and the implant on the other side had apparently decreased in volume without rupture or any visible fluid surrounding the implant.
      Our 40 year old female patient underwent insertion of bilateral PIP Hydrogel® implants of 350 cc volume approximately 10 years ago. She presented with asymmetry over the past 6 months; the right breast was smaller and the left was larger. After the augmentation she had been a 36DD but she was now wearing a 36F bra size.
      On examination, the left breast was larger than the right by at least 2–3 cup sizes and ptotic (Figure 1). The breasts felt different in consistency. It appeared clinically that the asymmetry was because the left breast had increased in size due to fluid surrounding the implant in the form of a reactive seroma.
      Figure thumbnail gr1
      Figure 1On examination, there was asymmetry, with the left breast larger than the right by at least 2–3 cup sizes.
      At operation it was found that both implants were marked as PIP 350 cc implants although the right implant was now smaller than the left (Figure 2a ). The right implant was intact but had lost approximately 12% of it's volume, weighing 308 g. There was no visible fluid surrounding the right implant.
      Figure thumbnail gr2
      Figure 2a) At operation it was found that both implants were marked as PIP 350 cc implants although the right implant was now smaller than the left. b) The left implant had a small split in the shell and appeared swollen. c) The turbid yellow fluid that was found surrounding the left implant. d) A capsule of moderate thickness with ‘granulomatous’ nodules on the surface was excised on the left side.
      The left implant had a small hole in the shell and appeared swollen weighing 393 g (Figure 2b). Surrounding the left implant there was approximately 600 mls of turbid yellow fluid (Figure 2c). The shell of the implant on the left appeared attenuated and stretched (Figure 2a and b).
      On the left side, a capsule of moderate thickness with ‘granulomatous’ nodules on the surface was excised (Figure 2d). On the right a thin capsule was not removed.
      Fluid sent for culture demonstrated no significant growth. The fluid sent for cytological examination and histopathological examination of the capsule from the left breast showed inflammatory changes. No exogenous refractile material was identified and there was no evidence of malignancy.
      It has been suggested
      • Adams T.S.T.
      • Crook T.
      • Cadier M.
      A late complication following the insertion of hydrogel breast implants.
      that the Hydrogel® implant undergoes spontaneous degradation with leakage of the osmotic Hydrogel® filler into the surrounding capsule. The reaction of the body to the extruded substance is that of a foreign body reaction with formation of a seroma collection. In a retrospective audit the incidence of rupture was found to be almost twice that of saline-filled implants.
      • Hardwicke J.
      • Gaze N.R.
      • Laitung J.K.
      A retrospective audit of Novagold ‘hydrogel’ breast implants.
      This is reminiscent of the Trilucent™ implants. The problems included an increase in osmotic pressure and rupture of the prosthesis.
      • Monstrey S.
      • Christophe A.
      • Delanghe J.
      • et al.
      What exactly was wrong with the Trilucent breast implants? A unifying hypothesis.
      Our analysis of the fluid did not reveal any visible degradation products of the implant and there is currently no evidence that the filler material of Hydrogel® implants is toxic to humans.
      Hydrogel breast implants withdrawn.
      Long term follow up is not yet available.
      We wish to highlight the unpredictability and unreliability of Hydrogel® implants and that leakage off the filler substance, about which there is no long-term safety data, may occur both through the shell and by rupture of the implant.
      Yours,

      References

        • Adams T.S.T.
        • Crook T.
        • Cadier M.
        A late complication following the insertion of hydrogel breast implants.
        J Plast Reconstr Aesthet Surg. 2007; 60: 210-212
      1. Hydrogel breast implants withdrawn.
        • Berthe J.V.
        • Van Gertruyden J.P.
        Osmotic instability of hydrogel-filled breast implants.
        Br J Plast Surg. 2001; 54: 465
        • Hardwicke J.
        • Gaze N.R.
        • Laitung J.K.
        A retrospective audit of Novagold ‘hydrogel’ breast implants.
        J Plast Reconstr Aesthet Surg. 2007; 60: 1313-1316
        • Monstrey S.
        • Christophe A.
        • Delanghe J.
        • et al.
        What exactly was wrong with the Trilucent breast implants? A unifying hypothesis.
        Plast Reconstr Surg. 2004 Mar; 113: 847-856