France’s National Security Agency of Medicines and Health Products (ANSM) has effectively banned implants made by South Korean company, Hans Biomed Corporation, after the firm’s products failed to meet safety standards. That’s just one piece of news emanating from the country that saw the PIP silicone-gel breast implant scandal in recent years.
A new report has been issued by the French regulatory agency, the ANSM. Find the report (in French) here. While it is clearly predicated by the terrible problems inflicted on women across the World by Poly-Implant Protheses under the stewardship of Jean-Claude Mas, it is deliberately not directed at PIP implants.
What we can glean from our pigeon-French translation is that not all is exactly rosy with the non-PIP silicone breast implant industry. Specifically one manufacturer, South Korea’s Hans Biomed Corporation, has (albeit unspecified) quality issues that have led the French to ban its products from the market. And French manufacturer Cereplas has suffered its own problems, manufacturing and sterilisation controls being deemed substandard and the company’s products temporarily suspended from sale until the issues are resolved.
The good news from the report, which details implant results between 2010 and 2013, is that there is no evidence of an increase in breast cancer risk compared with the general population, although six incidences of lymphoma in the mammary tissues remain unexplained and are to be investigated further.
Perhaps the most significant data relates to the lifespan of silicone-gel filled breast implants, which has historically been claimed to be at least ten years. The new report suggests it’s nearer to 7.6 years (+/- 4 years).
Equally striking is the incidence of rupture (remembering these are non-PIP prostheses) which shows 2169 reports during the period.
The report concludes that women should be better informed of the facts, especially the risks of undergoing breast enhancement using silicone breast implants. These obviously include the anaesthetic risk, the duration of the device, the potential for revision surgery to leave a poor aesthetic result and others including rupture, rotation, leakage etc. To this end it is collaborating with other bodies including the Haute Autorité de Santé (HAS) Health Authority to develop better information for women about what to expect from the procedure and the follow-up they are likely to receive following implantation.
Source: L’Agence nationale de sécurité des médicaments et des produits de santé (ANSM)