- Carl Heneghan, director, Centre for Evidence Based Medicine 1
- 1Department of Primary Care Health Sciences, University of Oxford, Oxford OX1 2ET, UK
Complete and utter confusion now reigns over Poly Implant Prosthèse (PIP) breast implants and what to do, particularly with regard to the evidence needed for their regulation, effectiveness, and, more importantly, safety. Confusion between the European and the American regulatory systems is not helping, and the situation needs radical reform.
The French government has advised 30 000 women to have their implants removed,1 the UK government says they are safe,2 and the United States has never let them on to the market.3 What is going on?
Problems occurred with decision making at the outset. In 1992, the Food and Drug Administration called for a voluntary delay on the use of silicone implants, allowing their use only in the context of clinical trials. This ban remained in place until 2006. In 1996, the FDA sent draft guidance on the types of study needed to demonstrate safety, and later that year PIP implants were cleared for approval under a Section 510(k) review application. Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in …