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.
The report has found that the MHRA:

• should review and further develop its communications capability to ensure it can rapidly establish and provide centralised communications regarding device alerts and related issues on an ongoing basis. This should be a proactive capability serving the needs of patients, professionals and the press and public;
• must be able to obtain evidence from a wider and more detailed set of sources, including robust data from clinicians. It needs to be at the forefront of using more sophisticated and rich sources of data to help determine if there are problems with a device; and
• must be able to routinely review the sum total of the information about specific higher-risk devices, so any problems are identified early.

Lord Howe said:

“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.

“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.

“It is clear that problems occurred that weren’t reported to the regulator. A vigilance system is only as good as the information that is reported to it. More needs to be done to ensure that problems with medical devices are reported, so problems can be identified and action taken to address them.

“This report won’t repair the distress caused to women who have PiP implants, but it should give them and the public reassurance that we have identified the lessons; that we will take all steps to act on them; and that, should something like this happen again, our systems for dealing with it will be stronger.

“The Government is supporting women affected by this scandal, and providing information based on sound, solid scientific and medical advice. The responsibility for the distress caused to UK women, and indeed many thousands of women worldwide, lies squarely with the fraudulent manufacturer which actively covered up its deceit and showed a complete disregard for the welfare of its customers. But we openly acknowledge that we must learn lessons from this in the future so we put all possible protections in place for patients.”
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 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.

Sir Bruce Keogh – the NHS Medical Director – is currently carrying out a separate review of the wider system of regulation for cosmetic interventions. His review will also look at whether a breast implant registry could be put in place in this country, to help monitor any problems that occur and perhaps make it easier to trace people affected if there is ever a problem in the future.

Women who have PiP implants and who are concerned are advised to:

• Find out if they have a PIP implant.
• Speak to their specialist or GP, if they had them done on the NHS, or clinic if they had them done privately.
• Agree what’s best. Get advice on whether or not they need further assessment, and discuss appropriate action with their doctor.

The NHS will support removal of PIP implants if, following a clinical assessment, a woman with her doctor decides that it is right to do so. The NHS will replace the implants if the original operation was done by the NHS. If a clinic that implanted PiP implants no longer exists or refuses to care for their patient, the NHS will remove the implants but not replace.

Notes to Editors

1. Lord Howe’s terms of reference were to look at:
• what information about PIP implants was available from routine adverse reporting systems;
• what external concerns about PIP implants were brought to the attention of the MHRA or the wider Department of Health, and when;
• how these concerns and any related information were handled;
• what advice was sought and from whom;
• what information was shared between MHRA and its counterparts in other countries in the EU and elsewhere;
• how decisions were taken, and who was involved in this process;
• what action was taken to safeguard and advise patients;
• whether action was sufficiently prompt and appropriate.

2. The terms of reference for Bruce Keogh’s review can be found at http://mediacentre.dh.gov.uk/2012/01/24/department-of-health-sets-out-scope-of-pip-implant-and-cosmetic-surgery-reviews/

The former Atomic Kitten star revealed recently that she had undergone a mini tummy tuck procedure and lipo to her stomach, legs and bum at The Hospital Group.

She was pictured outside the ITV studios yesterday (9 May) in a figure-hugging outfit, and her new appearance has drawn attention from The Mail Online.

The Mail Online said, “The mother-of-four drew attention to her toned body in a pair of tight leggings and a figure-hugging vest top as she posed up for photographers.

“There was certainly no sign of the ‘pocket of skin’ on her stomach which Kerry had gone under the surgeon’s knife to remove.”

If, like Kerry, you’re unhappy with your body after pregnancy, The Hospital Group could help you too. Contact us today for more information on liposuction and tummy tucks, and find out more about Kerry’s procedures with The Hospital Group.

The 54-year-old Silk star made the admission in an interview with the Radio Times in which she also discussed ageism on television.

She told the magazine, “I don’t care about getting older. I really don’t. I’m 54, I feel 26 and I act 12.

“I’d be a hypocrite if I said I’d never get a facelift – I’m saving up for one – but it’ll be tiny adjustments, the kind of thing that just makes you look less tired.”

Facial surgery from The Hospital Group can dramatically reduce wrinkles and help to rejuvenate your appearance. There are a wide variety of options for facelifts, get in touch to find out more here.

In an interview for June’s issue of Glamour, J.Lo discusses her famous figure and cosmetic surgery, saying, “I’d like to think I’ll age gracefully, but then I think, ‘Well, what if I do want a little bit of something?’”

She gave a similar interview in Vanity Fair last year denying that she had undergone any surgery but said, “I don’t know how I’ll feel about it when I’m 50.”

J.Lo’s figure has often been cited as one that women around the world want to replicate through cosmetic surgery, such as buttock implants, buttock lifts and breast enlargements.

If you are interested in cosmetic surgery, why not talk to us at The Hospital Group? We’re the UK leader for cosmetic surgery, with over 20 Clinics both nationally and internationally, and recent celebrity patients include Kerry Katona and Amy Childs.    Call a friendly advisor now on 0845 805 1047 or send us an enquiry.

The former Atomic Kitten singer and reality TV star revealed in her column for this week’s OK! Magazine that she had undergone cosmetic surgery.

She explained that she wanted the surgeries because her stomach skin had lost its elasticity due to her pregnancies and weight loss.

She wrote, “Right now I’m high as a kite on painkillers because I’m recovering from a tummy tuck.

“No matter how much weight I lost, I couldn’t get rid of a pocket of skin that hung like a kangaroo pouch.”

Kerry has undergone a number of procedures in the past, including liposuction and a breast reduction in 2008.

If, like Kerry, you are unhappy with your body after pregnancy or weight loss, The Hospital Group can help you too. To find out more or book a free consultation, visit our contact us page.

The 39-year-old former Playmate revealed she regularly uses the muscle relaxing treatment to maintain her youthful looks, but the trick is not to overdo it.

Jenny told Life & Style magazine: “I’m an obvious Botox user. I tell everyone.

“I get Botox in my forehead. I just have my doctor do a little shot.”

Botox from The Hospital Group is a simple, non-surgical, anti wrinkle treatment that can temporarily smooth lines for both men and women. After one 10-minute treatment of a few tiny injections, there’s a noticeable improvement in those persistent frown lines within days, and can last for up to six months.

The self-proclaimed Blonde Assassin has revealed to The Sun that fans have nicknamed her Gordon Ramsay because of her forehead wrinkles. 26-year-old Katie, who was the sixth person to be fired from the BBC1 show.

Now she says she wants to get Botox to smooth out her forehead.

She told the paper, “People keep saying I look like Gordon Ramsay. I didn’t realise how many conversations my forehead was having with the world. It’s made me want Botox.”

If you want to combat the signs of ageing, The Hospital Group has treatments to help, including Botox, Juvederm Dermal Fillers and Chemical Peels. Get in touch now to learn more about turning back the clock.

The figures from the International Society of Aesthetic Plastic Surgery (ISAPS) show that, in proportion to its population, South Korea is the world’s most surgery-mad country, ahead of Greece and Italy.

Twenty per cent of women aged between 19 and 49 in South Korea’s capital city Seoul admitted to having surgery when asked. In Britain, less than four per cent of the population has had a cosmetic procedure, below 20 other countries on the list.

The most popular procedures in Korea include eyelid surgery, lipoplasty and rhinoplasty. It is thought the rise is linked to the rise of pop music in the country.

For more information on eyelid surgery, liposuction and rhinoplasty with The Hospital Group, contact us here.

The former R&B singer and Miss America said of Botox that “no one talks about, [but] everybody does it.”

“The doctor that I go to for my Botox does it gently, so I can act. Which is important as an actress, to be able to be expressive,” she said.

The 49-year-old said that while some people are loathe to talk about it, she is “the girl that’ll say, ‘uh, I’ll tell you what I did.’”

If you share Vanessa’s point of view that Botox is nothing to be ashamed of, find out more about the treatment at The Hospital Group, or book a consultation now.

The statistics released by the American Society of Plastic Surgeons (ASPS) showed that ‘chinplants’ grew more than breast augmentations, Botox and liposuction combined in 2011.

There were 20,680 chin augmentation procedures carried out in the US in 2011, a 71 per cent increase on the previous year.

The operation sees a silicone implant inserted under the chin to give a stronger, more defined jawline. The rise in popularity has been linked to the increased use of video conferencing in modern workplaces.

Commenting on the findings, the ASPS president said: “The chin and jawline are among the first areas to show signs of aging. People are considering chin augmentation as a way to restore their youthful look just like a facelift or eyelid surgery.

“We also know that as more people see themselves on video chat technology, they may notice that their jawline is not as sharp as they want it to be.”

For more information about facial surgery from The Hospital Group, click here.