Celebrity support: Jennifer Aniston is a supporter of Ultherapy

It's not hard to see the appeal: a taut, firmer jawline, younger-looking eyes and lifted, youthful cheeks – and all without the need for a single injection, let alone going under the surgeon’s scalpel.

With celebrity backers including the ever-youthful actress Jennifer Aniston, 48, it is little surprise that the non-invasive ‘facelift’ procedure Ultherapy has been a hit with thousands of British women.

The treatment – administered by a device that emits ‘microfocused ultrasound’, similar to that used in scans on pregnant women – has the effect of lifting and tightening skin and is offered by cosmetic doctors in the UK.

But a Mail on Sunday investigation has uncovered concerns among doctors about complications that may arise afterwards, and a number of cases in which patients have claimed the process has left them looking older.

A leading cosmetic doctor claims that the treatment may ‘speed up the ageing process’, while one woman told this newspaper that she ‘aged overnight’ after having Ultherapy.

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Makers Ulthera, who are owned by German pharmaceutical giant Merz, are now facing a number of lawsuits from unhappy patients. It is alleged that patients have been left with hollowed cheeks and eyes, the loss of facial volume, and slackening and thinning of skin – a result of undergoing the treatment.

In legal papers, lawyers claim that when used on the face, the treatment resulted in ‘severe and permanent physical injuries’ and there was a risk of ‘fat loss, deformity, eye damage’ and ‘nerve damage’. One patient even states that her blindness was linked to the procedure. All these allegations are denied by Merz.

'It's devastating' 

Florida-based surgeon Dr Thomas Tzikas told this newspaper he has seen eight patients who allege complications after having Ultherapy treatment, and that some required surgery to fix the problems. He said: ‘These women, who are in their 40s, tell me their skin is much looser and more pliable than before. They can stretch and pull their skin, whereas the year before it was taut and seemed to have a lot more resistance, and there is loss of volume.

‘It’s devastating, because it’s like a speeding up of the ageing process. And it appears to be irreversible.’

Asked why some women report being satisfied with treatment while others suffer complications, he added: ‘These women are all of similar ages, usually in their late 40s to early 50s.

Legal action: above, the skin of one patient before she underwent Ultherapy treatment 

Action: after, showing that the skin appears to have aged. Several have reported the ageing process speeding up

‘Decreased oestrogen and other hormone production, in combination with the Ulthera treatment, may result in a very noticeable difference with their facial elasticity.’

Since it launched in 2009, more than 800,000 Ultherapy treatments have been performed worldwide, with 40,000 of them in Britain, according to Merz.

‘After treatment, the body’s tissue-repair process stimulates the production of new collagen and elastin [proteins found naturally in the skin that give it the firmness and structure which dissipate with age], creating a lifting and tightening effect,’ its website explains.

Ultherapy has proved effective and safe in numerous studies. According to data, patients may suffer ‘brief discomfort’ during the procedure, and adverse events are listed as ‘transient erythema [redness], edema [swelling] and occasional bruising’. Uncommon events include muscle weakness, transient numbness and weals – areas of raised, red skin – which, claimed a review, ‘appear to be due to poor treatment technique’.

In none of the available literature has volume loss or skin laxity been observed as a possible side effect. Dr Tzikas claimed: ‘We have seen fat loss [in the face] that seems to be triggered by the treatment in some women.’ It is this loss that may be responsible for the ageing effect.

Ultherapy has been cleared by US medical watchdog the Food and Drug Administration (FDA) for use in specific areas of the face: the brow, under the chin, the neck and decolletage. But many of the patients Dr Tzikas has seen and some of those taking legal action claim they were given treatment on the cheeks and around cheekbone area.

So, is the treatment being wrongly administered? If so, is that the reason for the devastating effects?

'Unacceptable' face use 

Tellingly, when Merz sought FDA clearance to market Ultherapy for the ‘full face’ in 2012, the request was deemed ‘unacceptable’ due to lack of evidence on this use, and the request was later withdrawn by Merz.

Legal documents obtained by The Mail on Sunday allege that the company marketed the treatment for use on the full face regardless – an allegation Merz denies. Currently on its website is the claim: ‘Ultherapy can help you achieve a fresher, more youthful look from your brow to your chest!’ An illustration of areas of the face that are treated appears to include the cheeks, and around the cheekbones and temples. And there are ‘full face’ before-and-after photos.

Controversial: a patient undergoing the Ultherapy treatment, which is a 'non-scapel' facelift

In a case against Ulthera on behalf of three American patients, personal injury specialists Harman Law state: ‘Merz requested from the FDA, and the FDA denied, clearance to market Ultherapy for use on the face… Merz nonetheless systematically and deliberately marketed Ultherapy for use on the entire face… despite having actual knowledge of Ultherapy’s risk of injury to the eyes and face.’

Merz denies these allegations, stating they are ‘without merit’, and concede only that an application was made to the FDA seeking to expand the indications for use to ‘full face and neck’.

A spokesman added: ‘We do not, and have not claimed, FDA clearance for a full face lift or otherwise make off-label [unapproved] claims… but physicians are not restricted from treating the full face.’

Such treatment would be considered an ‘off-label’ – the common practice of using a drug or treatment outside the terms of its licence.

While doctors may legally use their discretion to administer a drug or treatment ‘off-label’ if it is deemed in the best interest of a patient, and if there is good evidence such action would be beneficial, pharmaceutical companies are prohibited from encouraging this.

Merz said: ‘We do not promote or encourage off-label use of our device or any of our products.’

'I had to cancel wedding' 

Theresa Baldwin, 51, of Arizona, claimed to have been so devastated by what she says were the results of the Ultherapy she had in 2015 that she cancelled her wedding.

‘I’d started to see a few visible signs of ageing and went to a clinic to which I’d referred many clients in my work as an beauty therapist,’ she said.

She underwent two separate treatments at a total cost of £1,450. But instead of seeing any positive results, three months after the second treatment Theresa noticed the texture of her skin deteriorating.

‘I seemed to age overnight,’ she claims. ‘I had the sunken, hollow look of an anorexic and my skin was paper-thin. People at work were telling me to stop losing weight as my face was getting too thin – but I’d actually gained 5 lb.’

Theresa went back to the clinic, but claims staff refused to show her the photos they took beforehand that would prove the difference in her skin and offered only to undertake another treatment which she refused.

The Mail on Sunday has been in contact with several other women reporting similar problems, though they were unable to speak publicly due to the legal action. Harman Law in Atlanta has filed complaints on behalf of five women against Merz. These include ‘severe and permanent physical injuries including fat atrophy, herniation of the eye, muscle deterioration, scarring, nerve damage and vision loss’.

THE SOARING DEMAND FOR TREATMENT

The demand for non-invasive skin-tightening procedures has soared as numbers of those opting for traditional surgery plummet.

All scalpel-free lifts involve devices that emit some form of energy that penetrates the skin: lasers, radiofrequency waves and, as in the case of Ultherapy, ultrasound. The energy creates heat, leading to changes in the structure of the skin. It promises to be mostly painless, requires no injections and leaves no scars.

Healthcare provider comparison website What Clinic.com received 13,582 enquiries for non-surgical facelifts last year compared to 9,552 for those for surgery.

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It alleges that the device ‘was defectively designed because it is designed to deliver focused ultrasound energy in a manner that cannot safely be used on the face’, and that ‘the warnings provided with the Ulthera System are defective because Merz does not adequately warn about the risk of fat loss, deformity, eye damage, nerve damage, muscle damage and other severe, permanent injury’.

A woman in California is also taking legal action against a plastic surgeon and Ulthera Inc after having the treatment demonstrated on her at a conference in 2015. It is alleged that she ‘essentially lost all the vision in her right eye as a result of the mis-directed ultrasound energy destroying [her] lens’. She claims cataract surgery has not restored her vision.

Merz responded: ‘The company denies that Ultherapy treatment took place in any area that could result in ultrasound energy being delivered to the eye lens or that any alleged cataract or vision issues were caused by the procedure.’ Merz also claims it believed her vision had been restored by surgery.

It admitted there have been ‘a handful of individual plaintiffs’ who have filed product liability lawsuits involving Ultherapy, which the company ‘denies have merit’.

A spokesman said: ‘Ultherapy is a safe product that can provide excellent results. We estimate there have been more than a million treatments worldwide and believe that the vast majority of patients are happy with their treatment.

‘Ultherapy has been studied in clinical trials and was submitted to and cleared by the US Food and Drug Administration. The treatment has been studied by key plastic surgeons and aesthetic dermatologists and the results published in dozens of articles in reputable medical journals. There have been no reports of fat loss in any clinical trial conducted by Merz and journal articles also have not reported specific incidents of fat loss, to our knowledge.

‘There is widespread patient and physician satisfaction with the efficacy and safety of the treatment. We cannot comment further on the ongoing litigation except to say that we deny the allegations and strongly believe in the safety and efficacy of our product.’

'Caused by misuse' 

Dr Rian Maercks, a plastic surgeon in Miami, claims to have seen up to ten women a month for the past two years complaining about Ultherapy. He said problems many of the women are reporting may be down to practitioners performing the procedure without appropriate qualifications and experience – or misuse.

He warned: ‘I think the technology is only helpful if used below the chin.’

However, Alex Karidis, of the Karidis clinic in London, has used Ultherapy on hundreds of patients without any problems. He said: ‘All treatments carry risk. Botox can cause drooping and fillers can cause reactions. That doesn’t mean they’re bad.’

He added: ‘I’m happy with Ultherapy. In fact, my wife has just had it done for the second time.’ 

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