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Botulism’s TOXIC RISK

The rising number of botulism cases in the UK over the summer has sparked concerns around counterfeit botulinum toxin products, safety standards, and UK regulation.

The news from the UK Health Security Agency (UKHSA), of 41 cases of botulism poisoning in the UK over the summer, has posed a worrying threat to patients who have been searching for affordable botulinum toxin.

UNDERSTANDING THE RISKS OF BOTULISM

“Botulism is a serious illness caused by toxins that are produced by Clostridium botulinum bacteria. The bacteria attack the nervous system, causing muscle paralysis. Latrogenic botulism specifically refers to illnesses caused by medical and cosmetic treatments containing these toxins,” shares Dr Ellie Jolly, owner of The Ilkley Skin Clinic.

Symptoms typically appear within hours or days after being exposed to the bacteria, although symptoms can still emerge four weeks after the treatment.

“Botulism symptoms include difficulty swallowing and speaking, muscle weakness or paralysis, drooping of eyelids, and changes in vision. Gastrointestinal symptoms include nausea and vomiting. If left untreated and not managed emergently, this could lead to respiratory failure and possible death,” shares reconstructive surgeon and aesthetic doctor, Dr Ash Soni.

The investigations into these cases are still ongoing, but evidence so far suggests that the cases of botulism have been caused by the use of an unlicensed botulinum toxin-like product.

LICENSING AND THE RISE IN BOTULISM CASES

“I think it’s absolutely shocking and horrifying that it’s come to this, but it’s not unexpected, because of the situation with cosmetic regulation in the UK, anyone can pick up a needle and inject a member of the public space without any consequences,” shares GP and aesthetic practitioner, Dr Shirin Lakhani.

“It’s been a ticking time bomb, and we’ve been calling for regulation for over a decade. The government’s been slow to act on it, and in the meantime, there’s been a loophole that unqualified practitioners have exploited to be able to perform cosmetic injections.”

“There are more and more unregulated people providing aesthetics. Therefore, there is an increase in counterfeit products being bought from websites with no way to trace the origin of these or what they contain. Combined with potentially wrongful dosages and application of these products, has caused a rise in iatrogenic botulism,” adds Dr Soni.

“There are inexperienced providers and lay people, getting their hands on cheap products from the back of lorries or ordering from websites. They don’t know what the products are or what is in them. We have to be safe and cautious when it comes to this industry, and I cannot stress enough the importance of seeking treatments from a highly experienced provider.”

LOOKING OUT FOR BOTULISM IN PATIENTS

Regular botulinum toxin side effects typically resolve within a week, and “they tend to be localised, which means they are focused on one particular muscle area around where the injection was carried out. Symptoms can include temporary bruising, swelling, or redness, a mild headache, muscle weakness in the treated areas, and some mild muscle drooping,” notes Dr Jolly.

“Whereas actual botulism symptoms tend to be systemic, meaning they spread across the whole body as opposed to just being focused on the treatment area.”

UKHSA has issued national advice to clinicians to ensure that they look out for botulism in people who may have had a recent aesthetic procedure.

Botulism requires immediate medical treatment. If a patient has suspected botulism, it’s important to call 999 immediately or attend A&E. Hospital treatments are likely to include antitoxins, and if the patient has breathing difficulties, the patient will receive respiratory support and any other required treatments.

“Paralysis from botulism can take weeks to months to fully resolve; you may need physiotherapy or speech therapy for lingering muscle weakness, and to arrange follow-up appointments with your GP or neurologist to monitor progress,” shares independent nurse prescriber Julie Scott.

THE IMPORTANCE OF SEEKING REGULATED PROFESSIONALS

Botulinum toxin is a prescription-only medicine (POM) regulated by the MHRA in the UK and is generally considered to be a safe procedure. It should be prescribed by a healthcare professional who does a face-to-face consultation beforehand.

Dr Jolly explains, “It is important the public ensures their injector is a qualified medical professional, with adequate training, and credentials to perform botulinum toxin injections. Additionally, only medical professionals who can provide evidence of qualifications can purchase from reputable pharmacies. This ensures the legitimacy of the botulinum toxin products being used.”

Only licensed brands are available for purchase from accredited pharmacies. Practitioners have to prescribe these products for individual patients and cannot order them without a prescription. This ensures that only a provider with prescribing power is licensed to obtain botulinum toxin in the UK.

“People treat botulinum toxin like getting their nails painted or going in for a small beauty treatment on the high street, and that’s the problem. Attitudes towards cosmetic injections have changed and relaxed, but it’s important to remember that botulinum toxin is a powerful toxin. It is a prescription-only medication, and these treatments should only be carried out by medically qualified practitioners,” notes Dr Lakhani.

“With anything in this industry, it is imperative to go to an experienced aesthetic provider who is using the highest quality products. There are many products on the market, but very few are regulated and licensed for use in the United Kingdom. It is also important to always ask the provider what brand of neuromodulator is being used,” explains Dr Soni.

Dr Jolly advises, “It’s important to use fully licensed products that have been MHRA-approved. Products must also be stored properly, usually refrigerated to a certain temperature, and must be used within the expiration dates.”

“It’s also vital that proper protocols are followed, the procedure takes place in an adequate clinical environment, and sterile needles are used. Clinicians must also follow the appropriate dosing for each product, following the manufacturer’s guidelines very carefully.”

“With appropriate dilution of the product, an experienced provider, and the highest quality of product, the risk of botulism occurring would be rare. You must always approach these treatments in a safe manner and do your research,” adds Dr Soni.

Safety begins with the product itself, and before any injection, patients should, “inspect the vial or packaging, verify MHRA licensing, request the patient information leaflet, avoid online or informal purchases, beware of too good to be true deals, never self-inject, and know how to report problems,” shares Scott.

GROWING CONCERNS ABOUT COUNTERFEIT BOTULINUM TOXIN

Regulatory approved botulinum toxin treatments use MHRA-licensed products, “with proven safety profiles, they are administered by qualified professionals and require proper medical assessments and consent processes before they take place,” says Dr Jolly.

“Counterfeit injections, on the other hand, use unregulated substances and may contain higher concentrations or different toxin types. There is little to no quality control or batch testing used, and they are usually administered by unqualified practitioners.”

“If the price seems too good to be true, then it definitely is. Patients should ask practitioners for proof of qualifications, to see the product packaging, and licensing documentation. It is a red flag if no clear aftercare or emergency contact information is provided.”

Clients should research their injectors and understand their credentials before getting any treatments. “A thorough consultation is imperative before undertaking any injectable treatment. This should include examining a thorough medical history, an assessment of the areas that are to be treated, a full explanation of the recommended treatment, including any associated risks and potential side effects, and a discussion around the products being used,” shares Ellie Jolly.

The rise in cases of botulism and increase of counterfeit products, sparks concerns about regulation in the industry. “We must stress the importance of safety and why the experience of your provider matters. Some of the population are driven solely by how cheap a treatment being offered is,” shares Dr Soni.

“This is not a buy one get one free type of situation; this is your face, and your life.”

“Patients should be doing their homework prior to seeking treatment and should know everything about that provider. Botulinum toxin is a safe procedure in the right hands, but the public should know how to get into the safest hands,” Dr Soni continues.

FUTURE REGULATION

“The Government should also be clamping down harder on non-medical clinics. These providers should be banned. This is a serious situation and should be handled appropriately right up the chain.”

“There definitely needs to be stricter regulation of who can administer treatments, and better traceability systems in place for products,” recommends Dr Jolly.

“Regular safety audits of clinics carrying out the treatments would also massively improve safety standards and improve education about the risks of botulinum toxin use. It is pretty absurd that basically anyone can get their hands on these treatments and carry out procedures, with absolutely no training at all.”

“There should be standardised training requirements and regular competency assessments carried out, to ensure that everyone carrying out these treatments is fully qualified and understands how to spot a dangerous product.”

“My colleagues and I are incredibly worried, and we’ve been calling on the government to increase regulation. But it’s not just about putting in rules about who can prescribe the toxins and who can administer the injections. It’s about putting the enforcement behind it. So, if people are going outside the regulations, there are consequences for them,” adds Dr Lakhani.