Plinest® Polynucleotide Consent Form

Product

Plinest® is an injectable product designed to improve skin health and appearance. It contains polynucleotides derived from trout sperm. Polynucleotides are clinically proven to stimulate the biological regeneration of the skin architecture, including collagen, elastin, hyaluronic acid, blood vessels, pigment, and supporting fat cells.

Treatment with Plinest® is indicated to improve skin texture, discolouration, tone, fine lines, hydration, and radiance. Plinest® can also improve the appearance of scars.

A minimum of 2 treatments is required to achieve optimum results and longevity. However, you may decide to have a further 1-2 treatments depending upon your initial response, previous skin condition, and ageing. The initial course of treatments is delivered 3 weeks apart.

To maintain results, a further single treatment is recommended every six months.

Treatment

We advise applying a topical anaesthetic cream 30 minutes before your treatment for increased procedure comfort. Please arrange to arrive at the clinic 30 minutes before the treatment to have this applied for maximum effect and greater comfort during the procedure.

The treatment involves multiple micro-dose injections with a fine needle into the skin's surface. Depending upon the area to be treated, a blunt-tipped cannula may also be used.

A minimum of 2 treatments are required to achieve optimum results and longevity. However, you may decide to have a further 1-2 treatments depending upon your initial response, previous skin condition and ageing. The initial course of treatments is delivered three weeks apart.

Your treatment will involve a series of injections of Plinest into the superficial skin tissues. Once your photos have been taken and your consent forms have been read and signed, it will usually take up to 15 minutes to complete.

Following the treatment with Plinest, small bumps will be present within the skin where the Plinest material has been placed. These bumps will go away over 12-72 hours. Very rarely, these can take longer to dissipate, particularly in thin-skinned individuals.

Results—The results are not seen immediately. The treatment is expected to improve skin appearance and quality. Some improvement can often be seen within 4 weeks, with continued improvement over 6-12 weeks. Outcomes are dependent on biological responses and subject to lifestyle factors, which will vary between individuals.

Aftercare

Immediately following your procedure, slight redness and mild swelling around the treated areas are expected. These signs generally subside within 48 hours. The treated area will feel slightly tender to the touch or with extreme facial expression. If bruising occurs, it will typically resolve over 5-10 days. Applying Arnica gel or bruise creams may help for a quicker recovery.

Should you experience any unexpected side effects or concerns, please get in touch with the clinic on 01844 278362 as soon as possible. If it is outside clinic hours and you require urgent advice, please call the out-of-hours number detailed in your aftercare email.

What to do after treatment

  • Sleep with a few extra pillows at night for the first 1-2 days. This will help minimise morning swelling.

  • Take extra care when cleansing and applying products to the treated area for 48 hours.

What NOT to do after treatment

  • DO NOT touch or wear make-up in the treated areas for 12 hours.

  • Avoid strenuous or excessive exercise and swimming for 24 hours

  • Do not massage or manipulate the treated areas, and avoid facial treatments and massage for two weeks.

  • Avoid extended sun and UV exposure (including sun beds) and temperatures below 0 degrees for two weeks.

  • Avoid heat treatments such as sauna and steam for two weeks.

  • What to watch out for after treatment

  • Severe pain or increasing swelling is NOT normal and should be reported to the clinic immediately.

  • A rash or skin discolouration should be reported to the clinic immediately.

PLEASE NOTE: Should you experience difficulty breathing or swallowing following treatment with Plinest, you must attend to your local hospital emergency department and contact your practitioner.

Occasionally, you may require further treatment to obtain the desired results. You will have been offered a follow-up appointment for one month after completing your course of treatment. It is important that you attend this follow-up appointment following your first course of Plinest so that the final result can be assessed. Any additional required treatment will incur an additional charge and will be discussed with you before any treatment is given.  

Alternative Treatments

Other treatments for skin rejuvenation are available and may be discussed with your practitioner at any time. If you feel that the risks and side effects associated with Plinest are not acceptable, you should consider discussing an alternative treatment with your practitioner or not treating it at all.

Contraindications:

You cannot have Plinest if:

  • You are under 18 years of age.

  • You have a known hypersensitivity to fish or derivatives.

  • You have an active infection or inflammation near the intended treatment area.

  • You think you could be pregnant, are pregnant, or are lactating or breastfeeding. There are no adequate and well-controlled studies of Plinest in pregnant or nursing women, therefore safety cannot be guaranteed.

Cautions:

You need to tell your aesthetic practitioner if:

  • You have an upcoming important event. You will have visible skin bumps for 12-72 hours and may experience bruising. You should plan your treatment and social/work diary around this.

  • You suffer from recurrent bouts of herpes simplex (cold sores) infections near the intended treatment area. Plinest injections may encourage an outbreak. Patients with a history of cold sores may be given an antiviral three days before treatment.

  • You are taking blood thinning medications.

  • You are taking retinoid medications.

  • You are on immunosuppressive therapy, or therapy used to decrease the body’s immune response.

  • You have diabetes.

  • You suffer from keloid or hypertrophic scarring.

Material Risk (the level of significance you personally apply to the risks, side effects or complications of this treatment within your own circumstances):

As with any medical procedure, this treatment carries the risk of side effects or complications. Discuss these risks with your practitioner to fully comprehend their implications. Consider the risks in relation to your personal circumstances, including your health, lifestyle and career and decide if they are acceptable. If not, discuss alternatives or take more time to decide.

Associated Risks:

  • Injection site bruising, pain, swelling, rash, a sensation of heat and itchiness. These symptoms are usually mild and last less than a week but can last longer. Patients who are using medications that can prolong bleeding, such as aspirin, warfarin, or certain vitamins and supplements, may experience increased bruising or bleeding at the injection site. Swelling, heat and itchiness can be reduced with a cold compress and by ensuring you sleep with your head elevated for the first night after your treatment. Please remember that localised bumps at the injection site are normal and will usually diffuse within 12-72 hours but can take longer.

  • Little to no effect. Shorter or longer duration of effect. Plinest is generally a successful treatment for skin regeneration; however, from time to time, there may be little to no effect, or the effect may be shorter or longer than it is expected. This very rarely occurs, however, should you feel this has happened it is important you speak with your practitioner.

  • Asymmetry and dissatisfaction with the result. While your practitioner is trained in the successful delivery of Plinest, there is a risk that you may dislike its effect or feel that your treatment result is asymmetric. If this should occur, it is important to speak with your practitioner, as it may be possible to provide corrective treatment.

  • Acne-like formations.

  • Herpes (cold sores) re-activation. Injection of any kind carries the risk that an outbreak of herpes (fever blisters/cold sores/shingles) may occur in individuals who already carry the herpes virus. You should manage this as you would normally, such as by using over-the-counter cold sore medication; however, we advise that you please contact your practitioner as soon as possible.

  • Infection. As with any procedure that involves a break to the skin’s surface, an injection of Plinest carries the risk of infection. You should inform your practitioner if swelling, heat and/or discomfort occurs in the treated area for longer than a few days or suddenly occurs weeks or months after the procedure. This may require medical intervention from your practitioner, such as antibiotic therapy.

  • Papules and nodules. Very rarely, there is a risk that Plinest could cause small lumps or bumps, called granulomas, forming under the skin. In most cases, these will be non-visible and disperse in time. Where these bumps are visible, you may need further intervention from your practitioner to dissolve the product and/or a steroid injection.

  • Hypersensitivity/allergy/anaphylaxis. Most medications carry a potential risk of allergic reactions. Allergic reactions are possible with Plinest and numbing cream (anaesthetic), such as anaphylaxis (whole body autoimmune response with oral swelling, airways closing, and difficulty breathing), skin itching, skin swelling, hives, redness, and difficulty breathing. These reactions can occur immediately or days to months later. You should contact your practitioner if you feel unwell or believe you have had an allergic reaction. In cases of severe allergic reaction (anaphylaxis), you should seek immediate emergency medical care by calling for an ambulance.

  • Nerve injury. Nerve injury from needle puncture may occur rarely. It will most likely be temporary; however, it could also be permanent. This could result in loss of sensation and/or weakness of local muscles in the area. 

Photographs:

We need to take photos of the treatment area to document the original condition before treatment begins and to monitor results and potential changes throughout the treatment process. These photos will become part of your medical aesthetic treatment record at Lumiere Medispa.

You have the right to refuse consent for these photographs. However, please be aware that without this consent, we will not be able to treat you for medico-legal reasons.

If we wish to use your photos for any other purpose, we will always seek separate written consent from you. You have the right to refuse this additional use of your photos, and it is not mandatory to consent to any other photo usage to receive treatment.

Informed Consent:

This consent form is not meant to include all possible risks associated with a Plinest treatment, as there are both known and unknown side effects and complications associated with any medical treatment. We have written this consent form to ensure you are fully informed of the procedure, the reasons why you may not be able to receive treatment, and the known risks of a Plinest treatment.

By signing this consent form, you acknowledge and confirm the following:

Risks and complications

You have discussed Plinest's potential risks and benefits with your practitioner, and all of your questions have been answered to your satisfaction. 

You understand that medical attention may be required to resolve any complications associated with your treatment. In most cases, except those in an emergency, you should contact your practitioner for advice/treatment. 

Medical History

To the best of your knowledge, you have provided the details of your past medical history and will inform your practitioner if this changes before any future treatments. 

You understand that withholding aspects of your medical history could lead to serious physical and mental harm.

Contraindications & Cautions 

You are not pregnant or possibly pregnant, lactating or nursing, and you will inform your practitioner if this changes before any future treatments.

Fees & Charges 

You understand and agree that all services rendered will be charged directly to you, and you are personally responsible for payment. 

You further agree, in the event of non-payment, to bear the cost of collection, court costs, and reasonable legal fees, should they be required. 

Refunds

Fees charged for treatment are for the delivery of a treatment and the accompanying service, which is inclusive of the following; 

-Consultation and assessment 

-The provision of information and advice 

-The provision of the treatment itself, as described above

-Follow-up appointments and aftercare advice and support as appropriate

Whilst we undertake to provide excellent service, factual, honest, and ethical advice, safe, expert treatment in experienced hands, and only the best products, we cannot guarantee your results. We cannot offer refunds if the results achieved fail to meet your expectations. The successful outcome varies by degree, and how long these effects last varies from one individual to another and cannot be guaranteed. 

You understand that whilst you have been advised of a probable result, this should not be interpreted as a guarantee.  

You will contact your practitioner if you are unsatisfied with your treatment outcomes.

Aftercare

You have verbally discussed the aftercare required following a Plinest treatment and have been informed that you will also receive this via email. You understand the importance of following the post-treatment advice and agree to follow it. 

You understand that failure to follow this advice could lead to serious physical and mental harm.

Photograph Use Consent:

You understand that receiving treatment at Lumiere Medispa requires photographs to be taken of the treatment area. These photographs may be taken before, during, and after each treatment and will form part of your legal medical record at Lumiere Medispa. By signing below, you freely give your consent for your photos to be used solely for this medico-legal purpose. If we wish to use your photos for any other purpose, we will always seek separate written consent from you, and you have the right to refuse.

Valid Consent

By signing below, you acknowledge that you have read and understood this consent form and have had the opportunity to discuss any questions you have with your practitioner to your satisfaction. You consent to receive a Plinest treatment under the terms of this consent form and understand that you have the right not to consent to this treatment and that your consent is voluntary.