PIP IMPLANTS FOUND TO BE NOT TOXIC
The final report into the PIP breast implant scandal (cheap implants used for breast enlargement) has now been released and concluded that the gel found in the implants does not cause a long term threat to human health. The investigation was lead by NHS Director, Prof Sir Bruce Keogh. It says the implants, which were filled with unauthorised silicone, have been found to be neither toxic nor carcinogenic.
The review confirmed they do however have double the rupture rate of other implants tested.
Around 47,000 women in the UK have had the implants fitted. Prof Keogh said women had faced an "incredibly worrying time".
It’s thought around 95% were fitted privately. A minority of operations were carried out on the NHS, mostly for breast reconstruction patients following cancer treatment.
Earlier in January, Prof Keogh's team concluded there was insufficient evidence to recommend the routine removal of PIP implants. But it recognised the concern that the issue was causing.
In this week’s final report he said that repeated tests in many countries have "shown that the implants are not toxic and therefore we do not believe they are a threat to the long-term health of women who have PIP implants".
He concluded: "We have however found that these implants are substandard, when compared to other implants and that they are more likely to rupture. We would therefore advise that women who have symptoms of a rupture - for example tenderness, soreness or lumpiness - should speak to their surgeon or GP."
Consultant Plastic surgeon and president of the British Association of Aesthetic Plastic Surgeons (BAAPS), Fazel Fatah, said: "Despite rigorous testing showing no long-term danger to human health from the individual chemicals in the gel, the fact remains that PIPs are significantly more likely to rupture and leak and, therefore, cause physical reactions in an unacceptable proportion of the patients.
"We agree with the report findings that anxiety itself is a form of health risk and thus it is entirely reasonable for women to have the right to opt for removal - regardless of whether there has been rupture."
Throughout the UK any women who had PIP implants through the NHS have been given the option to have them removed and replaced free of charge.
In Wales the NHS will also replace those of private patients. In England and Scotland the NHS will remove implants of private patients but not replace them.
Last month, a separate review led by Health Minister Lord Howe examined the role of the Department of Health and the UK regulator the MHRA. It said serious lessons must be learned and questioned how well women with these implants were informed about the risks.
ARE MY FAKE BREASTS SAFE? STEPHEN SINCLAIR DEMONSTRATES IDEAL CONSULT
In a BBC3 documentary, Northern Irish model Gemma Garret told of her “nightmare” when she discovered she had ruptured PIP breast implants.
In 2008, aged 26, Gemma paid £4,500 for breast implants; she told the BBC “I definitely didn’t want the plastic look”. Three years on Gemma contacted her clinic for reassurance after feeling unwell and noticing a dramatic change to the shape of her breast. After no response she “lost faith” and found a new surgeon.
In 2011 surgeons discovered both implants had ruptured and silicone had leaked into her breast tissue. The cost to Gemma for the removal of these faulty implants was £11,500. Until recently, she had also endured uncomfortable outpatient procedures every six weeks to drain blood from cavities that formed.
In a BBC3 documentary, Gemma investigated why young women want to go under the knife and what the Government is doing to make women more aware of the risks associated with breast augmentation.
“Surgery is so available to young girls,” Gemma told the Belfast Telegraph.
“It can be advertised as a lunchtime boob job and young girls are sucked in and don’t realise all the risks. There should be better regulation of the cosmetic surgery industry.”
During the documentary, SaferCosmeticSurgery member Mr Stephen Sinclair was featured demonstrating how a comprehensive initial consultation should be.
Consultant Plastic and Reconstructive surgeon Mr Sinclair met with Gemma and her friend Carly aged 21 who was considering breast augmentation. Not only did Mr Sinclair explain the potential risks of this surgery, they also discussed the many options with this surgery with regards to type of implants, shapes and sizes. It is important that all your questions have been answered fully in order for you to make an informed decision. Stay clear of any clinics offering incentives for surgery and money off deals. Mr Sinclair explained how anyone considering a cosmetic surgery procedure should never choose a surgeon based on price.
BAAPS CALL AGAIN FOR IMPLANT REGISTER
The British Association of Aesthetic Plastic Surgeons (BAAPS) has agreed with the Government’s recent recommendation that a more stringent criterion is required to monitor medical devices in the UK. This all follows the welcomed review by the Government into the PIP scandal. The BAAPS has reiterated its previous calls for a compulsory breast implant register and mandatory safety audits for all practitioners.
The BAAPS President-Elect and consultant plastic surgeon Rajiv Grover has said;
“We welcome the findings of the Government’s review into the PIP scandal, and agree in particular that there should be a better system of reporting for medical devices, with data gathered from a wider set of sources that should be routinely reviewed. For the last few years, the BAAPS has been championing the reinstatement of a compulsory implant register that would monitor not just breast but all types of implant put into the body. The register is part of our regulation proposals put forward earlier this year and would immediately address all the recommendations put forward in this report, as would a mandatory safety audit based on the model that the BAAPS requires of all its members.”
According to consultant plastic surgeon and BAAPS President Fazel Fatah;
“Poor post-marketing surveillance of medical devices lies at the root of the PIP crisis. At the BAAPS we feel there needs to be significantly more stringent monitoring of all medical devices including breast implants and all cosmetic injectables, via compulsory, regular reporting of adverse effects and mystery shopping which are all part of our regulation proposals. This is an opportunity for the Department of Health to get it right, and put the necessary systems and checks in place to avoid a repeat fiasco. Clearly changes are also needed at European level of the CE marking process.”
BOTOX INJECTIONS FOR MIGRAINES MAY BE FUNDED BY NHS
It is estimated 700,000 people in the UK suffer with chronic migraines. These intense headaches often cause nausea and extreme sensitivity to light or sound. Sufferers of chronic migraines mean a patient must have headaches on at least 15 days a month, eight of which have to be migraines.
In the UK in 2010 Botox was approved as a treatment for chronic migraines, NICE is now considering whether the NHS should fund it.
In their final draft guidelines the National Institute for Health and Clinical Excellence (NICE) recommend Botox when other drugs have failed.
Director of the health technology evaluation centre at NICE, Prof Carole Longson said: "Chronic migraines are extremely debilitating and can significantly affect a person's quality of life.
"We are pleased that the committee has been able to recommend Botox as a preventative therapy for those adults whose headaches have not improved despite trying at least three other medications and whose headaches are not caused by medication overuse."
The final guidelines are expected in June.
Cost to the NHS?
For every 12-week cycle of treatment NICE estimated the cost to the NHS would be £349.40.
It is thought that the anti-wrinkle drug works by relaxing muscles and blocking pain signals.
Dr Fayyaz Ahmed, chair of British Association for the Study of Headache, said: "The headache experts with first-hand experience in treating chronic migraine know how debilitating the condition can be for some patients, and Botox can be a life changing treatment.
"We are pleased that NICE has recommended Botox for those who have failed to respond to first-line treatments."
Symptoms of migraine include:
- Severe headache
- Visual disturbances such as spots or flashing lights
- Sensitivity to light, noise, or smells
- Nausea and vomiting
- Tingling sensations, pins and needles, and weakness or numbness in the limbs
BOTOX IN YOUR TWENTIES – STEPHEN SINCLAIR TALKS TO THE BELFAST TELEGRAPH
Previously when Botox was first used as an anti-ageing treatment for men and women with moderate to severe frown lines, the average age of patients was 41. Last year it was indicated that teenagers had driven a 15% increase in the demand for Botox injections.
In a bid to freeze their looks and hold back wrinkles in later life twentysomethings are following their celebrity icons and undergoing anti wrinkle treatments. Celebrities from popular young shows such as The Only Way Is Essex and Xfactor have admitted to using treatments.
These non invasive procedures tend to last for around six months and at a cost of £200 - £500 per session - it’s an expensive outgoing for someone starting at such a young age. The Belfast Telegraph asked Consultant Plastic Surgeon, Stephen Sinclair, what the physical cost is to someone starting so young.
SaferCosmeticSurgery member, Stephen Sinclair, said there are no studies to prove that having Botox in your teens or twenties can have adverse affects or cause premature ageing. Given every client's individual history, it is difficult to pinpoint the best time to start treatment.
“As you age, the fat distribution in your face changes, putting more pressure on areas like the jowls or the nasolabial fold,” he explained.
“This normally starts to happen in your thirties or forties. There is a growing trend among young women to prevent lines and folds by use of Botox and fillers and these treatments are very successful.
“But having it done in your teens and twenties does seem early. The main thing young women should be doing now is leading a healthy lifestyle. Eat well, get exercise, don't smoke, don't binge drink. All these will help your skin in later life.
“Of course it can come down to genes and every person is different. Some women look younger than they are, some look older. It's hard to give a definitive time-point as to when you should start these treatments. But once you start losing fat, that's when they can be very useful.
“If you are thinking of having treatments done, it is essential to seek out a good practitioner and a good clinic, somebody who has knowledge of this field and the experience and expertise to do the job right.”
Please download the SaferCosmeticSurgery checklist for tips on choosing the right surgeon, if you would like to make an appointment with Mr Sinclair or an experienced surgeon who is more local to you please do not hesitate to contact us on 0800 622 6262.
LUNCHTIME BOOB JOBS BANNED
UK plastic surgeons have welcomed the decision to discontinue using Macrolane gel as a temporary breast enlargement procedure.
Manufacturers of the injectable filler have decided to withdraw the product for the use of breast enhancement this week following warnings from experts that the product could mask the signs of breast cancer.
The British Association of Aesthetic Plastic Surgeons (BAAPS) found in a survey that 25% of its members using Macrolane noticed patient complications from the filler.
The Medicines and Healthcare products Regulatory Agency (MHRA) said Macrolane could affect mammogram readings and make diagnosis more difficult.
A spokesman for MHRA confirmed there are no safety concerns with the product itself, and it could still be used for other purposes such as "augmenting body contour" and correcting soft tissue defects.
MHRA advised: "If women have been injected with Macrolane and subsequently had a mammogram, they should contact their GP to see if they need to be referred for further screening."
The “lunchtime boob job"
This less invasive procedure appealed to women looking for a temporary breast enhancement with little recovery. The injectable filler did not require the use of implants and results lasted for around 12 – 18 months. According to BAAPS figures in 2009 more than 1,000 women in the UK underwent this treatment.
BAAPS president Fazel Fatah said: "Any treatment can only be considered safe once it is known what long-term effect it has on cancer screening as this can affect such a high proportion of women.
"We have urged caution in the past against the use of fillers in the breast, especially when there is a lack of peer-reviewed results from controlled clinical trials."
A spokesman for Q-Med, manufacturers of the product in Sweden said all breast augmentation procedures, including those involving Macrolane, could interfere with mammograms.
"At present, there is a lack of consensus amongst radiologists regarding radiology examination of breasts treated with Macrolane," he said.
He said the decision to discontinue the product for breast enhancements followed consultation with regulatory authorities.
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