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January 18th, 2012
French breast implants scandal hits chemical distribution
Technical silicon grades for defective breast implants supplied by distributors
Over the last two weeks a number of articles were published that have named chemical distributors as suppliers of technical silicone grades to French breast implants manufacturer Poly Implant Prothèse (PIP). This company has declared bankruptcy and stopped all manufacturing activities in spring 2010 after inspections made by the French health authority agency AFFSA uncovered irregularities.
What has emerged from the investigations is that a range of technical / industrial silicone grades was used by PIP to mix a proprietary “gel” formulation for filling of the implants, which were used in ca. 400 to 500’000 operations, ca. 80% outside France, as reported by several media.
It appears that PIP concealed to the health authorities and the suppliers, a blatant disregard of the rules for life science applications, which stipulate the use of approved and controlled chemicals when manufacturing end products intended for use in the human body.
The company that so far got the most media attention is the world’s leading chemical distributor Brenntag (Mülheim an der Ruhr / Germany). The company has reportedly sold BAYSILONE silicone products (manufactured by Momentive Performance Materials, formerly GE-Bayer Silicones) to PIP. These products have a wide spectrum of uses, particularly in technical or industrial applications. Additionally a French distributor Gaches Chimie (Toulouse / FR) was mentioned in French media to have supplied silicone products to PIP. These materials, again technical grade(s), were mentioned to have been manufactured by Bluestar Silicones (previously Rhodia).
According to German newspaper reports, several lawyers are preparing product liability claims against Brenntag, arguing that the company had an obligation to monitor the use of the products, allegedly knowing that it was delivering technical grades into a “medical” application to a producer of implants.
Brenntag has denied any obligation to monitor the end uses of the products sold in a recent press release. “If the silicone oils delivered under the product name of BAYSILONE are part of the PIP breast implants, they could only have made their way into the implant through intentional criminal and improper use by the French manufacturer Poly Implant Prothèse (PIP), as the oils had been clearly classified as intended for industrial use only. Silicone oils can be sold without restrictions – for suppliers there is no legal requirement to monitor subsequent use.“
Brenntag has denied any obligation to monitor the end uses of the products sold in a recent press release. “If the silicone oils delivered under the product name of BAYSILONE are part of the PIP breast implants, they could only have made their way into the implant through intentional criminal and improper use by the French manufacturer Poly Implant Prothèse (PIP), as the oils had been clearly classified as intended for industrial use only. Silicone oils can be sold without restrictions – for suppliers there is no legal requirement to monitor subsequent use.“
Sources: Brenntag web-site www.brenntag.com, Handelsblatt web-site www.handelsblatt.com, La Dépêche web-site www.ladepeche.fr etc.
DistriConsult comment: This scandal will certainly lead to another wave of intensive discussion about what type of monitoring activities distributors have to undertake, in order to ensure the safe use of the products they supply to their customers. From what is known so far, this looks like a case of use of the chemicals supplied outside their approved applications, and intentional criminal activities on part of the end product mnufacturer. It was these activities, which were beyond the immediate control of the raw material suppliers / distributors, which led to medical implants that were not fit for purpose and highly unsafe. Nevertheless it is a stark reminder that product stewardship and the principles of Responsible Care require constant attention by everybody in the supply chain.
HGE – DCG / 18.01.2012