The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks

Plastic surgery is a sector of medicine that continues to show strong trends in growth. In 2011, women accounted for 90% of all procedures, with breast augmentation being the most common.1 There are estimated to be a total of 130,000 women in the UK who have received breast implants and around 47,000 of these were silicone implants manufactured by the French-based company Poly Implant Prothese (PIP).2 Following the misuse by PIP of industrial grade silicone, an expert panel, chaired by Sir Bruce Keogh, was appointed by the Department of Health to investigate the consequences of this scandal. They concluded in their final report of June 2012 that ‘PIP implants have not shown any evidence of significant risk to human health’.3 We disagree with their conclusion. Here we aim to share our concerns on the regulatory and quality control procedures that failed to safeguard thousands of women from the health risks associated with PIP breast implants. In light of the current ongoing review into cosmetic surgery which is also being led by Sir Bruce Keogh, it is vital that such failings are identified and tightened to ensure such a scandal is not repeated. What is a breast implant? A medical prosthesis used to augment, reconstruct, or create the physical form of breasts Modern (so-called fifth generation) breast implants usually contain either saline or a viscous silicone gel The outer casing, or shell, is composed of durable elastic silicone manufactured through a chemical process called vulcanization in which sulphur is added to the silicone to increase durability