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From: TSS ()
Subject: Four weeks ago, Sir Liam Donaldson, the Chief MO, warned that collagen fillers are capable of transmitting blood-borne diseases, including vCJD
Date: March 7, 2005 at 7:47 pm PST

Smooth operators
Evolence is the latest, much-hyped cosmetic filler to tempt the wrinkle-conscious. But are we putting vanity before safety? Jane Feinmann investigates

08 March 2005

Sn!ggering at actress Leslie Ash's disastrously over-plumped upper lip has become something of a national sport over the last few years. But cosmetic injectable implants are not always a laughing matter.

Four weeks ago, Sir Liam Donaldson, the Chief Medical Officer, warned that collagen fillers are capable of transmitting blood-borne diseases, including vCJD (variant Creutzfeldt-Jakob disease, the human form of BSE). He called for a clampdown on cowboy clinics and aesthetic fillers, some of which have been found to contain material from dead bodies and birds.

Even so, last Wednesday morning Annie Ashdown happily allowed a doctor to inject a couple of syringes of Evolence, a new, long-term collagen filler, into her naso-labial folds. A newcomer to cosmetic surgery, Annie was content to submit to the injection without the pre-treatment skin test to check for allergic response that is required for all collagen implants in the United States. And though the filler has only been tested on 12 people so far (as required by European law), the 41-year-old life coach and hypnotherapist had no qualms.

"Every day I help other people to improve their lives, and getting rid of lines that made me look severe was something I wanted to do for myself," she says. "The filler has been approved by the European authorities, and that's good enough for me. I felt totally confident about the procedure."

Annie is not alone. About 150,000 syringes of filler are injected every year in the UK, and the market is predicted to increase by 20 per cent annually, with growing numbers of men joining the so far largely female clientele.

Evolence, the filler that smoothed out Annie's smile lines, certainly has a lot going for it. The result of several years of research by the Israel-based bio-tech company ColBar LifeScience Ltd, it differs from other collagen implants in that it is derived from pigs, rather than cows - and hence it avoids the risk of BSE linked with bovine collagen. And, by using a type of collagen already widely used in heart, dental and eye reconstructive surgery, it can claim a long and unblemished safety record, thereby avoiding the need for costly and inconvenient pre-treatment allergy testing.

It also wins by being long-lasting (staying in place for about a year, compared with the normal three or four months for bovine collagen filler) while still being classed as a temporary implant - and thereby avoiding permanent mistakes ŕ la Ms Ash. This breakthrough in filler technology has been achieved by breaking down purified porcine collagen into molecules and then "cross-linking" or reconstituting them, using a sugar agent to strengthen the bond between each molecule - mimicking the use of glucose by the body's natural collagen.

Last week, Dr Lisa Delamaine, a Kent-based consultant in cosmetic and aesthetic medicine, said she was convinced the new treatment would prove a winner. "In such a crowded market, my patients want something that's guaranteed to be safe but also lasts long enough to avoid continuous repeat visits for top-up treatments, and this excellent new product looks set to be the gold standard soft tissue filler."

But with an increasingly wide range of fillers on the market, the beauty guru and author of The Lowdown on Facelifts and Other Wrinkle Remedies, Wendy Lewis, argues that safety must come first. "Women today want minimal invasion with maximum results and the proliferation of substances that can be put in a syringe has made it a veritable minefield out there. The big question on the mind of consumers has to be whether the product is safe."

So far, according to some experts, adequate safety tests on Evolence simply haven't been done. "This does seem to be a promising product, but I am worried that it is being promoted as being safe to use without requiring allergy testing," says the consultant dermatologist Dr Nick Lowe, author of Away With Wrinkles. "The research to substantiate such a claim has simply not been carried out. In the UK, aesthetic fillers are deemed to be 'medical devices' and therefore do not have to be subjected to the kind of specific clinical testing required by the American Food and Drug Administration."

He says the long-term safety record of porcine collagen as a surgical bulking agent doesn't necessarily provide any guarantee about its safety as an aesthetic filler. "Skin is such an active organ immunologically, far more so than any other part of the body. Fillers can react with the skin weeks or even months after treatment, causing disfiguring lumps and bumps. So it seems particularly important with a longer lasting implant that pre-treatment testing is carried out - at least until we have more data."

Dr Lowe, who is a consultant dermatologist at the University of California in Los Angeles, is supervising a properly organised clinical trial involving 100 patients that will compare Evolence with Restylane, a increasingly popular non-animal based filler made from hyaluronic acid. This is a synthesised, tissue-friendly substance that has been used in more than two million treatments since it was launched in 1996 and has been the subject of several positive clinical trials. And, while it lasts for only six months to a year, it is a near-perfect product for many practitioners.

"The beauty of Restylane is that it is a non-animal product as well as being one of the most tested dermal fillers available in the UK, with a clinically proven safety record," says Rajiv Grover, a consultant plastic surgeon at Mount Vernon Hospital in Middlesex and Harley Street. "This means there is little risk to my patients of transmitting disease or eliciting an allergic reaction, and I do not have to put my patients through the inconvenience of a skin test." Dr Lowe is equally enthusiastic. "My favourite filler has to be the Restylane family. It's very safe, with a risk of allergy in one in 1,600 patients. And there are a range of thicknesses, suitable for everything from fine lines to lips. There are also much bulkier subdermal products for facial sculpting, increasing definition of high cheek-bones, creating a more pronounced chin or restoring volume to cheeks that have become hollow as a result of ageing."

He would like to see far more stringent controls over aesthetic fillers, as is currently being considered by the Government's Healthcare Commission, with better pre-marketing testing and the use of them restricted to clinically responsible specialists in dermatology or plastic surgery.

"I certainly look forward to using Evalence once the tests are done. Until then, I would encourage anyone tempted to have an aesthetic filler to bear in mind that this is not an emergency treatment. It should be planned slowly and carefully and be carried out by a qualified practitioner - who will always put safety first."


* Evolence: porcine collagen, derived from pig tendon; lasts about a year; allergic reactions are rare.

* Zyderm, Zyplast: bovine collagen, derived from cow hides; lasts for up to four months; allergic reactions in three or four out of 100 patients.

* Restylane, Perlane, Sub-Q: synthesised, non-animal gel made from hyaluronic acid; lasts up to a year; can cause temporary swelling and tenderness; allergic reactions are very rare.

* Hylaform: hyaluronic acid treatment derived from cockerel combs; variable longevity; can cause temporary swelling and tenderness; allergic reactions are possible.

* Botox: botulinum toxin; lasts about four months; blocks nerve muscles to facial muscles, smoothing brow lines and crow's feet; can cause bruising, numbness, swelling and headaches in the short term; long-term risks are unknown.

* Artecoll, Dermalive, Softform, Outline: permanent skin implants made from synthetic ingredients; can cause redness and swelling in the short term; longer-term reactions include inflammation, excessive swelling, lumpiness and acne.

* Autologous fat injections, made from the patient's own fat cells; last a few months; can cause lumpiness and swelling. JF

Re: Neuroinvasion by Scrapie following Inoculation via the Skin Is Independent of Migratory Langerhans Cells


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