The PIP breast implant situation: are other companies prepared?

In March 2010 breasts implants manufactured by Poly Implant Prosthèse (PIP) were removed from the market following the discovery that non-medical grade silicone was used in the implants. The UK government subsequently advised explantation of PIP implants in symptomatic women (BMJ 2012;344:e478, 17 Jan, doi:10.1136/bmj.e478). The French manufacturing company declared bankruptcy therefore this substantial cost must be covered by others. The NHS has agreed to cover the cost of explantation and replacement of implants for all previous NHS patients. For private patients the cost will be determined by the individual clinics (BMJ 2012;344:e249, 9 Jan, doi:10.1136/bmj.e249). In the event that a private clinic is no longer operational, the NHS will cover the cost of explantation only (BMJ 2012;344:e972, 7 Feb, doi:10.1136/bmj.e972).

At the Royal Free Hospital, London we currently use breast implants from two USA companies (Allergan and Mentor) and one UK company (Nagor). We questioned how these companies would react and respond to a situation where their breast implants would require explantation on a global level. Each company was contacted to determine firstly if they offered any guarantee regarding their implants and secondly if they had considered and prepared for a situation whereby their implants would require explantation on a mass level.

All three companies proffer lifetime product replacement for implant rupture, Nagor also applies this offer to severe capsular contracture. These warranties are provided automatically and free of charge to all patients. The two American companies also provide up to £700 towards the costs of anaesthesia, surgery and the operating room. The UK company Nagor does not offer any financial assistance with these costs. Allergan and Nagor will provide a free contralateral breast implant if recommended by the surgeon. However, Mentor will only replace the ruptured implant.

When questioned about the hypothetical scenario whereby all implants would require explantation, the replies were of an analogous content. Each company initially provided assurance of the rigorous testing and recognised standards met by their breast implants and the materials used. There was a general consensus that this situation could never, and would never, occur with their implants. This in itself is a concerning statement as it implies a lack of provision for mass explantation. Although each company proclaimed insurance against product liability, not one could propose a specific contingency should the situation arise.

In conclusion, whilst it is reassuring that the materials used by these three companies are of a high quality and meet required standards, the reluctance of the companies to consider their position in a hypothetical global explantation situation is concerning and raises questions regarding who would be left to shoulder the responsibility and cover the expense in such a situation.

Competing interests: None declared