A breast implant register, improved product traceability, and a pre-market authorisation system are among the measures that have been recommended by the European Parliament today in the hope of preventing a recurrence of the PIP defective breast implants case which has affected hundreds of thousands of women across the EU .
Green MEP for London, Jean Lambert, has welcomed the outcome of the vote, which will also lead to more stringent safety on implants, including an implant recipient “passport”, which states the implant’s specific characteristics and its potential adverse effects, and national implant registers in each Member State .
Over 400,000 implants made by the French manufacturer Poly Implant Prothèse have been sold worldwide, with an estimated 47,000 women affected in the UK. The PIP implants were fitted with silicone containing industrial grade chemicals never intended for medical use, leading the French government to recommend their removal due to increasing evidence they could rupture.
Following the vote, Jean said: “An untold number of women have had their lives turned upside down by this scandal; women who have suffered from significant physical pain and have been left anxious over the long term consequences of the faulty implants to their health.
“By voting today to pass measures which could improve care and support for implant patients and step up safety checks, inspections and market surveillance on medical devices, the European Parliament has united behind women to ensure that such a criminally catastrophic fiasco cannot happen again.”
Notes to Editor
1. Today’s resolution can be read in full at: http://www.europarl.europa.eu/sides/getDoc.do?type=MOTION&reference=B7-2012-0302&language=EN The relevant EU legislation is to be revised later this year.
2. The text of the resolution stipulates that the inclusion of a patient’s personal details in the register should be subject to their consent.