Prime News

A UK 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.

'Previous studies have typically reported failure rates of between 2% and 5%, and these estimates have been based on secondary data,' said Mr Jan Stanek, lead author of the study.

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.

'It must be emphasised that this case was one of deliberate fraud by the PIP manufacturer which purposefully misled European regulators. Regulation alone cannot prevent fraudulent activity such as this,' said Lord Howe.

‘But serious lessons must be learned from this scandal. The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public.’

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.

The report also found that the regulators in all EU countries need to work better together to support early detection of problems, share the information they gather and take appropriate action to protect patients.

The UK Government will work to ensure that the ongoing revision of the European regulation of devices ensures the system works robustly and that information sharing across international boundaries is made much easier.

Increasing healthcare expenditure in emerging economies, including on aesthetic procedures, is having a positive effect on the expansion of the surgical sutures market, according to a new report by medical intelligence company GlobalData.

The report states that a rising interest in cosmetic procedures, combined with technological advancements, the growing demand for outpatient surgeries, and increasing healthcare expenditure due to older, more wealthy populations, in emerging countries such as China, India and Brazil will support market growth for medical equipment such as surgical sutures.

Emerging economies such as India and China are expected to drive the demand for operating equipment in the future, where the markets for surgical sutures are forecast to grow at a respective compound annual growth rate (CAGR) of 4.3% and 4.7%, to reach market values of $115.5 million and $274.8 million in 2018. The Brazilian surgical sutures market is also predicted to grow at a slightly lower CAGR of 3.8%, to reach $220.1 million in 2018.

The strong economic growth forecast in these emerging economies is expected to lead to increased investments in healthcare infrastructure owing to increasing patient affordability, the availability and demand for healthcare insurance, and general improvements in the healthcare services offered.

China and India are the most populous countries in the world, and are therefore anticipated to provide significant growth opportunities for manufacturers for years to come.

While the number of people opting for plastic surgery is increasing on a global scale, including in emerging economies, the highest concentration of surgeries still take place in the US.

According to statistics released by the American Society for Aesthetic Plastic Surgery (ASAPS) in April 2011, the demand for plastic surgery procedures increased by 9% between 2009 and 2010 alone, and has grown by a total 155% since 1997.

Around 9.5 million plastic surgery procedures were performed in the US in 2010, during which $6.6 billion was spent by US citizens on cosmetic surgery procedures, meaning it will be some years yet before emerging economies reach the kind of levels demonstrated by the US.