MEDICAL Evidence

Medical evidence: All PIP Implants should be removed
All surgeons, facing the realities of patients with PIP implants, agree, all should be removed.

Mr Adrian Richards Aurora Clinics

The surgical director of Aurora Clinics, Mr Adrian Richards introduces the video:





Medical Studies

Surface and mechanical analysis of explanted Poly Implant Prosthèse silicone breast implants

• Author: L. Yildirimer, A. M. Seifalian, P. E. Butler
• Published: Mar 08, 2013
• Pages: 761-767
• DOI: 10.1002/bjs.9094

Methods

Breast implants were obtained from women at the Royal Free Hospital (London, UK). PIP implants were compared with medical‐grade control silicone implants. Tensile strength, tear resistance and elongation at break were assessed using a tensile tester. Surfaces were analysed using attenuated total reflectance–Fourier transform infrared (ATR‐FTIR) spectroscopy. Spearman correlation analyses and Kruskal–Wallis one‐way statistical tests were performed for mechanical data.

Results

There were 18 PIP and four medical‐grade silicone implants. PIP silicone shells had significantly weaker mechanical strength than control shells (P < 0·009). There were negative correlations between mechanical properties of PIP shells and implantation times, indicative of deterioration of PIP shells over time in vivo (r_s = –0·75, P = 0·009 for tensile strength; r_s = –0·76, P = 0·001 for maximal strain). Comparison of ATR‐FTIR spectra of PIP and control silicones demonstrated changes in material characteristics during the period of implantation suggestive of time‐dependent bond breakage and degradation of the material.

Conclusion

This study demonstrated an increased weakness of PIP shells with time and therefore supports the argument for prophylactic removal of PIP breast implants.

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Expert Rev Med Devices. 2013 Mar;10(2):167-70. doi: 10.1586/erd.12.87.

Complications of Poly Implant Prothèse breast implants: the current discussion.

Kolios L, Hirche C, Spiethoff A, Daigeler A, Lehnhardt M.

Department of Hand, Plastic and Reconstructive Surgery, Burn Care Unit, University of Heidelberg, BG Trauma Center Ludwigshafen, Ludwig-Guttmann-Strasse 13, 67071 Ludwigshafen, Germany.

http://www.ncbi.nlm.nih.gov/pubmed/23480085

Against the background of the current discussion about Poly Implant Prothèse (PIP, Seyne-sur-mer, France) breast implants, we want to present a case demonstrating the complications such as implant rupture, silicone dissemination and level III silicone lymphadenopathy. A 29-year-old woman with cosmetic breast augmentation with PIP implants 5 years previously showed a sensitive swelling in her right axilla and neck region. All tests to detect an infectious or lymphomatous lymphadenopathy were negative. After ultrasound and MRI, rupture of the right implant was assumed and multiple pathologically enlarged lymph nodes up to supraclavicular region were shown. An excision biopsy of one axillary lymph node was performed; the histological examination detected a strong silicone lymphadenopathy. Surgical removal of both implants as well as capsulectomy was performed and 14 axillary lymph nodes up to level II were resected. Histologic evaluation confirmed the previous results. Our case underlines the actual discussion concerning increased rupture rate and massive silicone lymphadenopathy by PIP implants.

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