Dallas McMillan's Blog

A breast implant register, more stringent checks and product traceability, and a pre-market authorisation system are among the measures proposed by the European Environment and Public Health Committee to prevent a recurrence of the PIP defective breast implants case. The resolution was passed unanimously.

An estimated 400,000 implants made by the French manufacturer Poly Implant Prothèse have been sold worldwide. These implants were widely used in the UK, France, Spain and Germany. However, the number of women who have received them is unknown.

The resolution has called for "increased traceability of implanted medical devices", and for "increased coordination between Member States when it comes to reporting and warning about serious side effects or damage done" by these devices.

It also says that patients' associations, patient groups and health care professionals must be encouraged to report all adverse events and harmful effects of these devices without being hampered by a great deal of red tape.

The resolution asks the European Commission to introduce a pre-market authorisation system for certain medical devices and to do more to ensure patients are aware of breast implant risks.

MEPs have also called for the introduction of an implant recipient's passport, stating the implant's specific characteristics and its potential adverse effects, and the introduction of a breast implant register in each Member State. These registers should be interconnected and allow for the exchange of information when needed, for example in cases where important defects are detected in implants.

A system of collective redress should also be put in place to help patients obtain compensation when medical devices go wrong.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated advice to surgeons that patients with a particular type of metal-on-metal hip replacement should be monitored annually for the life of the hip replacement.

This updates previous advice from April 2010 that patients with this type of hip replacement need only be monitored for a minimum of five years after their operation.

The updated advice is included in a new MHRA Medical Device Alert that has been issued to clinicians for the management of patients with these hip implants to minimise the risk of having to undergo further surgery to correct complications.

Dr Susanne Ludgate, Clinical Director of the MHRA, said:

“Clinical evidence shows that patients have a small risk of suffering complications from having metal-on-metal hip implants. These implants have in most cases completely transformed the lives of patients who in the past were subject to increasingly severe pain and progressive lack of mobility."

She went on to say that: “By monitoring patients every year, any complications will get picked up earlier and more complex surgery on the patient can be avoided.”

Following recent concerns regarding French Poly Implant Prostheses implants, the Government has announced a review, led by Professor Sir Bruce Keogh, the NHS Medical Director, to look at the arrangements for ensuring the safety of people seeking cosmetic interventions such as breast implants and dermal fillers.

In addition, the Care Quality Commission is to conduct a swift review of private clinics that offer cosmetic surgery. They will look at whether they meet essential levels of safety and quality and at the information and support they provide to their patients. Where a provider does not meet these requirements, the CQC has a wide range of enforcement powers that it can use to protect the safety of patients.

Professor Sir Bruce Keogh, said:

“The safety of people who decide to have cosmetic surgery or a cosmetic intervention is my sole aim. The vast majority of practitioners in the cosmetic industry are professional and well skilled – but I’m concerned that the sector as a whole does not have the systems for monitoring the results for patients and alerting us to possible problems.

“I will work with the industry to improve regulation and governance and increase consumer confidence.”