PIP breast implant scandal

December 2011–January 2012

In December 2011, the French government advised women in France with breast implants manufactured by Poly Implant Prothèse (PIP) to seek to have their implants removed. During the previous year, the company was found to have been producing faulty implants that contained industrial silicone and were prone to bursting. There were growing concerns over a possible link between the implants and cancer.

Concerns over PIP implants predated 2011, with complaints of ruptured implants both in France and the UK, and in other EU countries.

The Medicines and Healthcare Products Regulatory Agency (MHRA) noted in 2008 that a rise in complaints could be attributed to the rise in supply and sales of PIP implants.

In December 2011, the MHRA advised that there was no evidence of a link between PIP implants and cancer and that it did not support the routine removal of PIP implants. However, it advised women who were concerned about ruptures to visit their surgeons.

It was estimated that 40,000 women in England had PIP implants, including women who received NHS reconstructive surgery following cancer treatment.

On 6 January 2012, the Department of Health announced that the NHS would support the removal of PIP implants if, informed by an assessment of clinical need, risk or the impact of unresolved concerns, a woman, with her doctors, concluded that removal was the right course of action. The NHS would replace the implants if the original operation was carried out by the NHS.

An expert group chaired by Professor Sir Bruce Keogh found that chemical and toxicological analyses of PIP implants had not shown any evidence of significant risk to human health, but that PIP implants were significantly more likely to rupture. The group's advice was that all providers of breast implant surgery should contact any woman who had or may have had PIP implants and offer them a specialist consultation.

Source(s)

Chrisafis A.
French government 'to order women to remove defective breast implants'.
The Guardian; 2011.

Meikle J, Chrisafis A.
NHS patients believed to be among faulty French breast implant victims
The Guardian; 2011.

Keogh B.
Poly Implant Prothèse (PIP) breast implants; final report of the expert group.
Department of Health; 2012.

Department of Health.
Department of Health statement on breast implants and response to expert group report.
Department of Health; 2012.