CONSENT FORM 01.2020-A
DERMAL FILLER PENILE AUGMENTATION
SPECIFIC RISKS There are some specific risks related to this treatment.
Infection: Infection is a risk of the procedure. Please ensure you take the full course of antibiotics provided to you at the clinic as instructed. Please inform the doctor if you are allergic to penicillin. If you have not collected antibiotics following your procedure, please inform the doctor as soon as possible. Should you suspect an infection please contact the doctor as soon as possible. See additional information on Infection below.
Allergy: An allergic reaction to Hyaluronic acid is rare and usually mild. An allergic reaction may appear as a rash on the skin. If an allergic reaction should occur, treatment with Hyaluronidaise and antihistaminic medication may be necessary and may lead to the dissolving of some or all of the filler.
Irregularities: Filler can be moulded during the first week by the patient Additional filler can be added at the patient’s expense to improve the result if necessary. However, in some cases, it may not be possible to mould out all irregularities and it may be necessary to treat such irregularities or lumps with Hyaluronidase (dissolving) enzyme (applicable to Hyaluronic acid fillers only; some fillers such as Ellansé cannot be dissolved away). See more information regarding Hyaluronidase below.
False expectations: For example; a patient might incorrectly believe that it is possible to change the size of their penis from very small, to very large, with only a small amount of filler. A patient might also incorrectly believe that this procedure will increase their erect penis length when this is not an expected outcome.
Numbness: The penis can feel numb for a few days particularly the dorsal (upper) side of the penis.
Pain: The penis can be tender for 1 week after the procedure, depending on the type of filler used.
Swelling: It will usually take up to 2 weeks for swelling to go down. If a large amount of filler is injected or if the body responds with significant swelling it can take 1 month to completely disappear. Only after 2 weeks, or once the swelling has gone down, will the patient know the result of the procedure.
Bruising: This varies significantly from patient to patient and is usually resolved within 1 week. In rare cases bruising and haematoma can be substantial.
Delayed onset inflammation: In rare cases, inflammation in the penis can occur months after the procedure and in some cases will require the filler to be dissolved away, or additional treatment to be undertaken.
Filler migration: It is possible for dermal filler to move from the area in which it was first injected. Filler is more likely to move during the first week after it has been injected and before it has integrated with the surrounding tissue. Please refer to the Instructions Document regarding limiting physical activity and the wearing of appropriate undergarments.
Inform your doctor if you have a history of dysmorphia, mental illness, any past urinary or genital infection such as MSD, herpes, mycosis, chlamydia but also HIV, hepatitis or immune disease and any Sexually Transmitted Infection (STI). Your doctor should be informed of all previous surgery, medical conditions, and details of penile augmentation procedures performed in the past as well as any medication you are taking.
You agree to read the Instructions Document provided by email (please search your Spam folder and inform the clinic if you do not have a copy). A copy can be downloaded from www.androfill.co.uk/aftercare You agree to contact the clinic on 020 3633 0026 within 12 hours of the procedure to further discuss aftercare over the phone.
DESCRIPTION – Hyaluronic acid dermal filler
Hyaluronic acid-based dermal fillers are biodegradable injectable gels with an estimated half-life (the point at which 50% of the substance is gone) of 12 to 24 months, depending on the specific brand of filler, and depending on the patient’s own specific characteristics.
Hyaluronic acid fillers vary in terms of:
- How long they are estimated to last;
- How firm they feel in the penis (from slightly softer to slightly harder than a normal erection);
- How easy they are to mould following the procedure and in the following days until the filler has ‘set’;
- Generally, the harder a filler is, the more difficult it will be to mould smooth should there be a need to press out any initial irregularities in the first few days following a procedure.
- The degree of swelling or inflammation they are likely to cause;
- The presence or absence of lidocaine laced into the filler (designed to reduce the pain associated with filler injection), please inform the doctor if you have any intolerance to lidocaine (rare);
- How uniformly the filler will biodegrade and the degree of isovolumetric degradation before total resorption.
INDICATIONS – What the product is designed for and ‘off label’ use.
Most of the Hyaluronic acid filler used in the clinic is designed to restore and create volume in the face. Hyaluronic acid fillers are also used in other areas of the body such as the buttocks. As yet, there is no CE mark approved Hyaluronic acid filler designed specifically for the penis. Hyaluronic acid filler has been used ‘off-label’ for penile augmentation for 20 years and has an excellent safety profile. The first peer-reviewed publications authored by medical doctors and published in medical journals dating back to early 2000.
Andofill Clinic (Dr Gary Horn), has performed more than 2,000 Hyaluronic acid penile augmentation procedures over the past 5 years. Dr Horn is comfortable that the procedure is generally safe and well-tolerated when using a reversible Hyaluronic acid-based filler.
CONTRA-INDICATIONS – When the product should not be used.
- Patients who tend to develop hypertrophic scarring;
- Patients with known hypersensitivity to hyaluronic acid;
- Patients with known hypersensitivity to lidocaine or to amide-type local anaesthetics;
- Patients suffering from porphyria;
- Patients presenting cutaneous inflammatory and/or infectious processes (herpes, etc.) or Sexually Transmitted Infections STIs;
No clinical data is available regarding the efficiency and tolerance of Hyaluronic acid in patients having a history of, or currently suffering from, autoimmune disease or immune deficiency or being under immunosuppressive therapy.
Patients with impaired immune systems may be at an increased risk for infection after injection of dermal fillers depending on their disease state. A determination of individual risks and benefits should be considered before deciding whether or not to proceed with the injections.
There is no available clinical data concerning the tolerance of Hyaluronic acid filler in patients presenting a history of severe and/or multiple allergies.
Patients showing a history of streptococcal disease (recurrent sore throats, acute rheumatic fever) may be subjected to skin testing for hypersensitivity before any injection is administered.
Patients on anti-coagulation medication or using substances that can prolong bleeding (warfarin, acetylsalicylic acid, nonsteroidal anti-inflammatory drugs, or other substances known to increase coagulation time such as herbal supplements with garlic or ginkgo biloba, etc.) must be warned of the potential increased risks of bleeding and haematomas during injection.
Patients must be informed that there are potential side effects associated with the injection of this product, which may occur immediately or may be delayed.
These include, but are not limited to:
- Inflammatory reactions (redness, oedema, erythema, etc.) which may be associated with itching and/or pain on pressure and/or paresthesia, occurring after the injection. These reactions may last for a week.
- Haematomas and severe bruising are possible.
- Induration or nodule formation.
- Staining or discolouration of the injection site might be observed.
- Poor effect or weak filling/restoration effect.
- Rare but serious adverse events such as occlusion, associated with the intravascular injection of dermal fillers have been reported which if untreated could lead to skin necrosis and damage to underlying structures.
- Abscesses, granuloma and immediate or delayed hypersensitivity after hyaluronic acid and/or lidocaine injections have also been reported.
- Patients must report inflammatory reactions which persist for more than one week or any other side effect which develops, to their medical practitioner as soon as possible.
- Inflammation, infection, fistula formation, hematoma, seroma, extrusion, induration formation, inadequate healing, skin discolouration, inadequate or excessive augmentation, loss of correction, interference with local circulation if injected into a blood vessel resulting in vessel laceration, occlusion, embolism, infarction, and abscess at implant site which may result in induration and/or scar formation.
Injection related reactions, including swelling. Redness, pain, itching, discolouration or tenderness may occur at the site of the injection. These usually resolve spontaneously within several days after the injection. Nodules or granulomas may form requiring treatment or removal. Adverse events, other than mentioned above, could occur as can be the case with any medical intervention.
DESCRIPTION – Hyaluronidase
Hyaluronidase is an enzyme which breaks down hyaluronic acid, the main ingredient in many dermal fillers.
The ability to adjust or completely reverse the result of a Hyaluronic acid penis filler procedure using this enzyme is a benefit of choosing a Hyaluronic acid filler. Other fillers, such as Ellansé cannot be dissolved away. Hyaluronidase is not suitable for everyone and some people should not use it. Other people should only use it only with special care. It is important that the person prescribing this medicine knows your full medical history.
Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:
- Are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine.
- Have an infection in or around the area where hyaluronidase is going to be injected.
- Have cancer at the site where hyaluronidase is going to be injected.
Everyone’s reaction to medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all.
The frequency of the following side-effects are unknown:
- Allergic reactions such as anaphylaxis.
- Injection site problems such as irritation, infection, bleeding and bruising.
- Oedma has been reported in association with hypodermoclysis.
Taking other medicines
- While there are no known important interactions between hyaluronidase and other medicines, Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with it.
- Complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.
RISK OF INFECTION
As a matter of general principle, injection of any substance into the body is associated with a risk of infection. This risk increases in areas such as the genitals.
The risk of infection is lowered by taking antibiotics following the procedure. Please take the full course of antibiotics as instructed by the doctor. Let your doctor know if you are allergic to penicillin. Let the clinic know if you forget to collect your antibiotics. Having a shower before the treatment is recommended.
After the procedure, if your incisions have healed over, you should gently wash the area with soapy water in the shower. You should not soak in the bath for at least 5 days or until your incisions have healed. You can further lower the risk of infection by washing your hands before handling the penis in the week after the procedure, and by not having sex for two weeks following the procedure. Maintain good general hygiene including wearing clean underwear each day.
The risk of infection is low, however, if it does occur it should be treated seriously and without delay by contacting Dr Horn and Androfill, or if unable to (for example if you are abroad) by seeking medical assistance.
If at any time after the treatment you suspect an infection, please contact the clinic immediately on 020 3633 0026 or text message +44 7426 040086
Infection may show up as a raised lump following your procedure, and may also be painful and red.
Below is an example of what an infection might look like in the penis.
Further signs of an infection can include feeling generally unwell; a high temperature (fever) of 38C (100.4F) or above; swollen glands in the groin (a more likely location for swollen glans), armpits or throat (less likely). An infection may be red, raised, painful and needs to be addressed urgently with antibiotics or other treatments.
If an abscess develops it might require draining. This might involve making an incision or inserting a needle into the abscess to drain out any fluid and puss. In rare cases, some or all the filler may need to be dissolved in the area of the infection, assuming you have used a Hyaluronic acid filler (which can be dissolved).
If you suspect an infection has occurred, contact the clinic or your doctor urgently to begin a course of antibiotics or other treatment that may be deemed necessary. Delaying treatment for an infection may result in damage to the penis in extreme cases or if left untreated for extended periods.
During this procedure, we need to be careful to not place too much product towards the head of the penis, especially in uncircumcised men. If too much filler is placed near the head of the penis it may make it more difficult for some patients to retract the foreskin of the penis.
The risk is higher in patients who already have mild to severe Phimosis (Phimosis is a condition in which the foreskin of the penis cannot be pulled back past the glans/ penis head).
Uncircumcised patients may be more prone to filler migrating to the foreskin region. This may present as small lumps of filler visible when the foreskin is retracted.
Keep the penis supported in supportive underwear (briefs) for the first 7 days following the procedure, so that gravity, diffusion, and the impact of walking does not cause the filler to migrate down towards the head.
If you notice excessive product around the head, try to massage this back up the shaft towards the base of the penis before the filler is integrated/’set’ (at around 7 days following the procedure). It may be easier to push migrated filler out of this region when erect, if possible.
If you are unable to push the filler out, it may need to be spot dissolved back in the clinic, and you may lose a small amount of the filler as a result.
If you are unsure of anything, please call the clinic on 020 3633 0026 or send a text message to +44 7426040086.
GLANS PENIS INJECTION – for Augmentation / Treatment of Premature Ejaculation
Filler can be injected into the head of the penis to increase the size of the head, or to reduce the sensitivity of the head for the treatment of premature ejaculation.
Injecting filler into the head of the penis is higher risk and requires a specific Hyaluronic acid filler to be used (although not specifically designed for use in the glans).
Some of the risks are infection, necrosis, excessive reduction in sensitivity or inadequate reduction in sensitivity.
For premature ejaculation. A reduction is sensitivity is not guaranteed. We have found the treatment to be effective in roughly 50% of patients completing a full 6 ml course of treatment (2ml x 3 sessions).
It may take three or more treatments (typically using 2ml per treatment) to observe any reduction in sensitivity.
It is possible that no reduction in sensitivity is achieved. It is also possible that too much sensitivity is reduced, in which case dissolving some of the filler might restore sensitivity.
For augmentation of the penis head/glans penis: it may take a significant volume of filler to produce a noticeable increase in size. This procedure has a significantly lower satisfaction rate (around 50%) compared to Hyaluronic acid injections along the shaft of the penis (more than 80% satisfaction rate). This may be due to unrealistic expectations of the increase in size that can be achieved.
Generally, filler injected in the head of the penis produces results that are underwhelming (in terms of the increase in size). Increasing the size of the penis head may also make it more difficult to retract the foreskin and is not recommended for patients with Phimosis or a tight foreskin, to begin with.
ELLANSÉ / Poly-e-Caprolacton (PCL)
Dermal Filler Penile Augmentation Procedure
Note: This section is relevant to patients being treated with Ellansé filler. Most patients are not treated with Ellansé and instead receive a lower risk Hyaluronic acid-based filler. If you are in any doubt as to the type of filler being injected, please ask the doctor.
Ellansé is a higher risk filler that lasts up to 4 years, depending on the version used.
An important reason that penile augmentation using Ellansé is considered a higher risk procedure, is that unlike Hyaluronic acid fillers, Ellansé cannot be dissolved away. The result cannot be reversed or altered, such as with the use of Hyaluronidase (dissolving) enzyme.
The principal component in Ellansé is synthetic Poly-e-Caprolacton (PCL) microspheres suspended in a gel carrier which encourages the production of new collagen and autologous connective tissue. Ellansé is totally bioresorbable and slowly leaves the body over a number of years. This does not necessarily mean that complications or damage caused by the filler will necessarily favourably resolve once the filler has left the body.
If a problem occurs with Ellansé, there may be little that your doctor can do to fix the issue. For example, if the filler migrates or if the result is not even, or if you develop nodules or other complications such as detailed below.
Treating a complication caused by Ellansé (if it is possible to treat the complication) could be expensive for the patient and the complication or treatment of the complication might cause permanent penis damage. The higher risk nature of Ellansé must be understood and accepted by the patient.
Ellansé comes in 4 varieties, S, M, L and E. ‘S’ is designed to last up to 1 year in the body. ‘M’ is designed to last up to 2 years in the body. ‘L’ is designed to last up to 3 years in the body. ‘E’ is designed to last up to 4 years in the body.
Ellansé is not designed for injection in the penis and there have been no formal long-term studies on the risks or the short- or long-term implications of injecting Ellansé in the penis.
DESCRIPTION – Ellansé dermal filler
Ellansé is a sterile, latex-free, non-pyrogenic, totally bioresorbable, non-permanent implant, whose principal component is synthetic Poly-e-caprolacton (PCL) microspheres suspended in a gel carrier of phosphate-buffered saline (PhEur), glycerin (PhEur) and carboxymethylcellulose (USP).
PCL is a well-known totally bioresorbable soft medical polymer. PCL is used in numerous CE-marked and Food and Drug Administration (FDA) approved commercial bioresorbable product applications for several decades worldwide and has demonstrated an excellent safety profile.
CONTRA-INDICATIONS – When the product should not be used.
- Ellansé is contraindicated for patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
- Ellansé is not to be used in patients with known hypersensitivity to any of the components.
- Ellansé should not be used in the case of acute or chronic skin disease (infection or inflammation).
- Ellansé should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.
- Ellansé should not be administered in case of current cortisone treatment, as the growth of connective tissue fibres might be inhibited.
- Ellansé should not be used in or close to sites where previous skin augmentation procedures have been applied, especially with permanent Implants.
RISKS – Ellansé
In common with or in addition to the risks described above for Hyaluronic acid fillers:
Risks include granuloma (hard lumps forming in the penis), infection, other tissue reactions, and inflammatory responses. Inflammation may be treated with steroids.
Use of Ellansé at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the inflammatory process has been controlled.
Use of Ellansé if a Sexually Transmitted Infection (STI) is present should be deferred until the inflammatory process has been controlled.
Special care should be taken to avoid injection into the blood vessels. An introduction into the vasculature may occlude the vessels and could cause infarction or embolism.
Injection related reactions, including swelling. redness. pain, itching, discolouration or tenderness may occur at the site of the injection. These usually resolve spontaneously within several days after the injection.
As with any implant material possible adverse reactions that may occur include, but are not limited to the following: hypersensitivity, allergic reactions, inflammation, infection, fistula formation, hematoma, seroma, extrusion, induration formation, inadequate healing, skin discolouration, inadequate or excessive augmentation, loss of correction, interference with local circulation if injected into a blood vessel resulting in vessel laceration, occlusion, embolism, infarction, and abscess at implant site which may result in induration and/or scar formation.
Nodules or granulomas may form requiring treatment or removal.
Adverse events, other than mentioned above, could occur as can be with any medical intervention.
Patients who are using medications that can prolong bleeding, such as aspirin or warfarin, may, as with any injection, experience increased bruising or bleeding at the injection site.
Minimize exposure of the treated area to excessive sun and UV lamp exposure and extreme cold weather until any initial swelling and redness has resolved.
If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with Ellansé there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Ellansé is administered before the skin has healed completely after such a procedure.
LEGAL – TERMS AND CONDITIONS
FILLER LIFE EXPECTANCY
The life expectancy of Hyaluronic and PCL fillers depends on the type of filler used and varies from patient to patient. Generally, in the case of Hyaluronic acid fillers, after an estimated 12 to 24 months, depending on the exact model of filler and the patient, around half of the filler will remain. The rest will have been metabolised and passed out of the body.
In the case of Juvederm Voluma the manufacturer states that the filler is proven to last up to 2 years. When treated again at 2 years, patients needed less product to achieve their original results. It should be noted that the manufacturer’s claim relates to the use of the filler in the cheeks and not in the penis, where it may or may not last as long. https://www.juvederm.com/cheek-fillers
In exceptional circumstances the body can metabolise filler at a rapid rate, meaning that the filler is absorbed in a few months although this is highly unlikely. The body’s immune system can also cause the filler to reabsorb rapidly. Filler reabsorption rates are impossible to predict and vary from patient to patient, therefore they are not guaranteed.
SIZE INCREASE ACHIEVED
It is not possible to precisely predict the size increase that will be achieved by a given amount of filler as there is variation between patients for reasons such as variation in penis size, thickness and elasticity of tissues and skin.
Dermal filler injections do not change the erect length of your penis; however, they may (or may not) increase the flaccid length of the penis. Differences in skin elasticity can explain why, for example, a 10 ml procedure on patient A results in a smaller or larger increase in size than a 10 ml procedure on patient B.
More filler can always be added at subsequent visits to the clinic if the result achieved does not provide the desired increase in girth. It may be better to take less filler on your first visit, in case the result achieved is larger than you expected. If the penis is too large after the procedure, some of the filler can be dissolved to reduce the size (only Hyaluronic acid fillers can be dissolved away).
A complaints procedure is found at www.androfill.co.uk/complaints you agree to be bound by the complaints procedure and the result of the findings of the independent complaints adjudicator.
CONTRACT / LIABILITY
Dr Gary Horn GMC 4267803 is ultimately responsible for the outcome of surgical and non-surgical procedures.
Androfill staff are not medically trained and should not be relied upon for medical advice.
Dr Gary Horn is obliged to hold the medical malpractice insurance necessary to carry out medical procedures of the nature described in this document.
ET Trading Ltd trading as Androfill / Androfill Clinic acts as an introducer and facilitator and is not responsible for medical outcomes. Medical staff are contracted to ET Trading Ltd rather than being employees of the firm. As a matter of convenience, ET Trading Ltd may take payments on behalf of Dr Gary Horn; however, the legal contract formed is between Dr Gary Horn and the patient.
ET Trading Ltd UK Company Registration Number 06980289 trading as Androfill. ET Trading Limited acts as a credit broker and only offers credit products from Paybreak Limited t/a Afforditnow. ET Trading Limited is authorised and regulated by the Financial Conduct Authority. Our FCA registration number is 765790. Credit approval is subject to age and status and approval by third-party credit providers. Androfill is a registered trademark.