PRESS & MEDIA

www.fox9.com/news/fda-lasik-eye-surgery-...-draft-guidance-2022

’The FDA wants LASIK eye surgery patients to know more about the risks of what’s become a popular procedure for correcting vision problems.
The federal agency has issued a 25-page draft report outlining how doctors should better inform patients about the potential for double vision, dry eyes, poor night vision, eye pain and other side effects after LASIK surgery.

But eye doctors who’ve been successfully doing the procedures for 25 years say they’re already trained to give patients a "balanced discussion" on the benefits and risks. Doctors also say the draft doesn’t reference the government’s own studies about how safe and effective the procedure is.

The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of LASIK devices," the FDA draft says. "These labeling recommendations are intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of LASIK devices that uniquely pertain to individual patient."

Dr. Vance Thompson, incoming vice president of the American Society of Cataract and Refractive Surgery, is one of many doctors who take issue with the draft guidance.

"There are important risks and side effects that are well-understood, as with any procedure, but one of the main reasons it was deemed safe and effective is a lot of these things get better with time," he told FOX TV Stations. "We have wonderful tests to be able to show us if the patient is a good candidate for LASIK."

What the draft guidance is lacking, Thompson said, is information on the benefits of LASIK. Most people come out of LASIK with 20/20 vision or better, according to the Mayo Clinic, and the majority of LASIK patients are satisfied with their surgeries.

Thompson said the draft includes claims that "aren’t evidence-based," and they can needlessly scare people when they don’t take into account each patient’s individual situation.

"We just think that when we talk about balance, it’s important to not only mention the risks, but mention its advantages and put them in perspective," Thompson said. "The well-documented studies on the safety and efficacy, it’s not in here."

"What we basically asked the FDA to do is withdraw the document, and if they want to carry forward with it … to work with us, to re-examine current patient-education materials, and identify opportunities that may improve patient education about LASIK procedures," Thompson continued.

Nearly 700 people have submitted comments on the FDA draft guidance since it was issued in July.

The comments are a mixed bag of satisfied and dissatisfied LASIK patients, as well as doctors who say the FDA’s report is biased and "based on the premise that LASIK devices approved by the FDA are unsafe and unreliable in the hands of duly certified and licensed physicians."’

700 includes positive comments from lucky patients and biased surgeons, a minuscule fraction of the countless thousands of people damaged by lasik that campaigners are aware of, across the US, UK, and worldwide.

So yes, let’s talk ‘evidence based’ and ‘bias’! Because in the eleven years of my work I’ve seen nothing but bias, entirely in favour of the industry, with damaged patients silenced, when the press and media are threatened with legal action if they dare publish/broadcast the truth!

And sadly, as I have personally experienced so many times over the years of my work, the industry generally succeed in scaring them off!

But it’s all bluff people! Publish, let us talk on camera, because I guarantee no-one will sue you, not here in the UK at least, because truth from damaged patients can be supported by hard evidence!

Even Optical Express, having issued court proceedings against the Daily Mail for defamation in 2015, dropped their claim in 2017 after I provided the legal team for Associated Newspapers with witnesses and evidence that would have destroyed them in court, and publicly!

And when you have people like Steve Schallhorn involved in approval of laser eye surgery, medical devices, etc…, I trust the FDA as much as I do every organisation in the UK that allegedly protects the public - that’s as far as I can throw a double decker bus (not least the General Medical Council (GMC)*), because there is too much money involved, Big Pharma greasing hands at EVERY level!

However, it is encouraging to know that the industry is so bothered by this draft that they’re asking for it to be withdrawn by the FDA.

NB: It should be noted that UK campaigners call for regulation of the entire #refractivesurgery industry, not only Lasik, but ALL non medically essential eye surgery, including Lasek/PRK, ICLs, and RLE/NLR (refractive lens exchange aka natural lens replacement).

And since 2014, the problems with RLE continue to rapidly increase exponentially, being sold to people far too young to undergo what is essentially cataract surgery - some only in their thirties, shockingly removing perfectly healthy natural lenses. This is because the profit for lens surgery far exceeds that of laser eye surgery.

*To protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.

This FDA draft guidance is causing concern within the refractive surgery industry worldwide, who are naturally claiming sensationalism and denying the truth


www.bostonglobe.com/2022/12/07/nation/la...ions-fda-draft-says/

ITV's This Morning presenter Philip Schofield irritating the hell out of me again recently, not least because - claiming to be 'at the cutting edge’, he continues to promote eye surgery to his fans, who lap up every word as gospel, when he really doesn’t know what he’s talking about

July 2020, during lockdown, when countless thousands of people were dying, this selfish man was whining that his vision had ’slipped’ since his freebie #lasereyesurgery a number of years earlier (performed by Dan Reinstein & featured on This Morning), complaining to co-host Holly Willoughby, ‘the laser place isn’t open!’, who sensibly responded: ’I like glasses!’

A few months later, he was whinging about floaters again!

This self obsessed diva is now posting about having had a vitrectomy, claiming, 'If you have been told "just live with them" that is not necessarily true, I’m sure there are exceptions, but they can be fixed.'

In fact the majority of people do have to live with floaters, unless so debilitating that they seriously affect their quality of life, or, like Phillip Schofield you have enough money to get what you want - not what you necessarily need!

And if Schofield gave a flying f*ck about anyone else other than himself (crocodile tears on screen don’t move me), I trust he wouldn’t be clamouring for attention in this pathetic manner, when there are countless numbers of people with far worse problems than his, many of them My Beautiful Eyes Foundation clients!

'Adamant that he was not suffering from retinal detachment, Schofield described his floaters as having “literally blighted my otherwise brilliant eyesight.”’*

This begs the question, how did his eyesight become ‘brilliant’, given his moans in July 2020, as surely he'd have milked it if he'd had more laser surgery?

'Phillip Schofield to be first Brit to have pioneering eye surgery as he reveals debilitating condition’**

For the record, Schofield was far from being the 'first Brit', and how long can a procedure be termed ‘pioneering’?

Regardless of which, I have no doubt that GPs, optoms, and retinal specialists (besides Prof Stanga, presumably now inundated with private consultation bookings) won't thank him for encouraging requests for surgery that most people cannot have, contrary to ‘Dr' Schofield’s expert opinion!

Media personalities should NOT be advertising ANY surgery, nor claiming to be experts at the 'cutting edge’!

And instead of posting topless selfies on his Instagram, methinks Schofield would be better employed inviting Dan Peedell (and others damaged by London Vision Clinic owner Dan Reinstein) to share their experiences on This Morning.***

Greg Brady’s story re AccuVision and Prashant Jindal also ignored by the media, though widely published by the mainstream press a few months ago.

Similarly, Paul Dance’s suicide, a result of devastating results of his lens replacement surgery at Optegra Eye Hospital, persuaded by their highly paid Clarivu brand ‘ambassador’, This Morning presenter Ruth Langsford, telling everyone, ’Do it, do it, do it!’.
Paul’s tragic story was TV sofa gold, yet totally ignored by the media.****

And my invitation in 2019 to guest alongside Dan Reinstein withdrawn by This Morning, after the cowardly doctor refused to appear with me, highlighting the fact that TV producers consider promotion of #refractivesurgery more important to viewers than educating them about the very real risks, and irreversible damage that so often happens, not forgetting the cost to the NHS!*****

All the above stories, and thousands more, are worthy of a seat on TV sofas, instead of giving free fluffy publicity to surgeons who continue to damage patients’ eyes, often in litigation, and successfully kept from public consumption.

Time for balance not bias!

* www.express.co.uk/life-style/health/1641...y-symptoms-treatment
** www.ok.co.uk/tv/daytime/phillip-schofiel...on-floaters-22842211
*** 2 February 2020: www.opticalexpressruinedmylife.co.uk/ind...london-vision-clinic
The Mirror took Dan Peedell’s story offline due to complaints from Dan Reinstein. However, it's available to read here: www.pressreader.com/uk/the-people/20200202/281840055651824
**** www.bbc.co.uk/news/uk-england-hereford-worcester-55079239
*****17 Oct 2019: www.opticalexpressruinedmylife.co.uk/ind...london-vision-clinic

Please visit ‘Dr Prashant Jindal | MPTS Fitness to Practise hearing’ topic for full story



www.easterneye.biz/eye-surgeon-prashant-...te-being-on-holiday/
www.pakistanweekly.co.uk/eye-surgeon-pra...te-being-on-holiday/

Please go to ‘Dr Prashant Jindal’ topic for full story and more articles



‘Dr Prashant Jindal, who is pictured with stars including Shane Warne, is accused of signing documents indicating that he had conducted the procedures despite knowing he had not. The General Medical Council alleges that Jindal is unfit to practise because of misconduct.

The tribunal heard that one of Jindal’s patients, Greg Brady, was about to become a professional boxer when he had the surgery. Brady is pursuing a civil claim against AccuVision for damage to his eyes. He was referred to as patient B at yesterday’s hearing.’

Pants on fire Jeremy Vine

Some readers will remember him raving about laser eye surgery on his Channel 5 show on 3 May 2019 (talking complete uniformed bullsh*t!): ‘The number of times it goes wrong in any way at all is tiny tiny tiny - we're talking about in tens of thousands… And actually it doesn’t wear off, in the situation that I’m in, it doesn’t suddenly, slowly go back...'

'Jeremy Vine On 5 04 May 2019 11:26'
www.opticalexpressruinedmylife.co.uk/ind...eneral-chat?start=70

The day before his consultation with a surgeon - the clinic given priceless free publicity - he also proclaimed on his BBC Radio 2 show: ‘We’re talking full laser!’.

And whilst I don't watch his C5 show, I was told by a viewer who does, that no more mention of this was ever made.

However, about a week later, Jeremy Vine told his BBC Radio 2 audience that he’d been screened out for surgery because his eyes were too dry.

Yet on his Channel 5 show last week, he told a guest: ‘I very nearly did [have laser], but lockdown stopped me!’

Really Jeremy?

In fact, the first UK lockdown came into effect on 23 March 2020 - approx 10 months after telling his Radio 2 listeners that he had dry eyes, and COULD NOT HAVE surgery!

Could he not have been honest, and simply said that his eyes were too dry - or was that a lie?

Perhaps the deluge of messages he received from damaged refractive surgery victims changed his mind, and so to avoid backtracking on his effusive recommendation for unregulated refractive surgery (and looking even more stupid), he invented an excuse.

One way or another, Jeremy Vine lied!

The Times Business section today ?


www.thetimes.co.uk/article/optics-are-lo...ress-owner-d8jfvgr7p

The Times online has a paywall, but you can sign up for a free month's subscription if you'd like to comment (as I did), and cancel before the first payment is due!



Article content:
'Profits at the owner of the Optical Express chain have increased sharply.*

Annual accounts for Lorena Investments show a 15 per dip in turnover to £99.1 million, but reduced costs, partly as a result of fewer high street outlets and a smaller marketing budget, lifted pre-tax profit to £20.1 million in 2020, up from £648,000 previously.

That profit included £7.5 million of government grants.** The company also benefited from lower exceptional charges of only £23,000, compared with more than £4 million in the previous 12 months.

David Moulsdale started Optical Express in 1991 with a shop in Edinburgh providing eyecare, spectacles and contact lenses. The company has gone through a big restructuring over the past decade, which includes Moulsdale, 52, now its chairman and still the owner, buying Optical Express’s debt from Royal Bank of Scotland in 2013.

There are 105 Optical Express outlets on British high streets, as well as sites in the Republic of Ireland, Croatia and Germany. Turnover fell by 17 per cent to £89.6 million in 2020, while Europe was down marginally at £9.5 million.

Stewart Mein, 50, a Lorena Investments director, said: “Our business continued to move from the high street, as leases concluded, to purpose-built, state-of-the-art clinical facilities driven by consumer demand. In turn, property overhead costs were driven down, whilst continuing to invest heavily in technological solutions which provide further enhanced levels of clinical outcomes, patient satisfaction and safety.”'

*Increased no doubt because Optical Express (and Optimax/Ultralase UK ) operated throughout most of lockdown, claiming they were providing necessary surgery, and taking business from other providers who had closed to abide by government restrictions. Even the #NHS cancelled many necessary ops!

NB: I have good reason to believe that OE's profits will take a sharp downturn by the end of 2022, as they are also aware!

**Sickening

Don't be fooled, this wasn't easy!

It took 2 months to get this story published, with Marcello Mega and I jumping through countless hoops - Daily Mail Health Correspondent Shaun Wooller finally getting it over the line for print around 6pm on Friday evening

Many thanks to both journalists, to the ophthalmologists who helped with the science stuff, but mostly to the Optimax victims who agreed to go public with their experiences, including those whose interviews didn't make it to press on this occasion due to lack of space.

However, as I previously mentioned, there is more to come...

Meanwhile, it's still VERY important to share Saturday's post, or this one, as we don't know how many people are out there, worldwide, blissfully unaware of their urgent need for an endothelial cell count check!

Anyone with Phakic lenses implanted in the early 2000s who would like further information and advice, please contact: sasha@mybeautifuleyes.co.uk

“Sasha Rodoy, of My Beautiful Eyes Foundation, which supports patients who have had poor outcomes from refractive eye surgery, said: ‘I am gravely concerned about the patients Optimax has been unable to contact... they may be walking around with a potential time bomb in their eyes.’”
www.dailymail.co.uk/news/article-9934377...-damage-corneas.html



More to come about this story re Optimax & owner Russell Ambrose

Belated update to my 25 May post (scroll down to catch up), when BBC Morning Live presenter Gethin Jones had laser eye surgery ’top up’ with Julian Stevens at Moorfields Private Eye Hospital

Deafening silence when I asked Gethin Jones whether he or the BBC had paid for his surgery, or if it was ‘gifted’ - aka a freebie in return for priceless advertising!

So I sent an FOI to the BBC, who surprisingly gave me the information I'd requested without a fight!



However, they probably realised that had they not, I would certainly have argued that such information could not possibly fall under the purpose of 'journalism, art or literature', given that this was a blatant advertorial, making a mockery of their claim: 'It is important that the BBC is an independent and impartial news organisation.'