Dallas McMillan's Blog

A review into the PiP breast implant scandal has found that, although the regulator acted appropriately and followed scientific and clinical advice, there is room for improvement and serious lessons must be learned.

Health Minister Lord Howe’s report into PiP breast implants has looked at whether the UK regulator – the MHRA – and the Department of Health acted appropriately both before and after information about the problems with these implants came to light.

The report states that the MHRA and the Department of Health must learn lessons so that they can continue to improve their approach to communicating with affected individuals and the general public, particularly around issues that cause such understandable anxiety. They must ensure that full, clear and accurate information is made available promptly in a way that is easily accessible and reflects the concerns that weigh so heavily on the lives of patients who are affected by doubts over the safety of specific medical devices.

The role of the MHRA is to monitor all incidents that are reported to it, make sure that these incidents are investigated fully and that any necessary action is taken. The evidence shows that the regulator did this but that improvements are needed in its communication and data collection and the whole European system and processes for gathering and analysing data where concerns arise.

Lessons need to be learnt by the MHRA, the Department of Health and the wider system so it can uncover problems early, be better placed to take robust action and provide clarity for the public should anything like this happen in the future.

An eleven-year-old girl has been awarded around £11 million in compensation for serious injuries she suffered at birth, reports the Guardian.

Milly Evans was born in Lincoln County Hospital. Her family claim that during labour her heart beat was not adequately monitored, and therefore medical staff did not notice quickly enough that she had an abnormal heart beat and was in distress. Milly was born with cerebral palsy and cannot speak. She will be dependent on care for the rest of her life.

According to the Guardian, the United Lincolnshire Hospital NHS Trust had admitted liability for Milly's injuries, but contested the level of damages being sought. An agreement has now been reached, and Milly will be paid a lump sum of £5.9 million and receive annual payments for the rest of her life, to help meet the costs of her ongoing care requirements.

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.

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.”