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INFORMED CONSENT DOCUMENT FOR TREATMENTS WITH MACROLANE™ VRF20 AND MACROLANE™ VRF30 FIRST AND SURNAME OF THE PATIENT’S LEGAL REPRESENTATIVE LEGAL REPRESENTATIVE, RELATIVE, LEGAL GUARDIAN) I STATE THAT
NAME OF THE DOCTOR WHO GIVES THE INFORMATION N° OF MEMBER OF THE PROFESSIONAL BODY (IF APPLICABLE) has explained to me that in my situation it is advised that I be treated with Macrolane™ VRF20 and/or Macrolane™ VRF30.
1. I have been informed that Macrolane™ VRF20 and Macrolane™ VRF30 (hereafter In case of breast treatment, I have been informed of the need to comply with standard referred to as Macrolane) are products based on NASHA™ gel, a gel containing breast screening procedures. If a mammography is planned I should inform the stabilized hyaluronic acid of non-animal origin. Hyaluronic acid is a substance that can radiologist about the breast implant and provide the radiologist with information about Macrolane. I have been advised that Macrolane is detectable on breast radiology and might affect the interpretation of mammography. This means that additional Macrolane is biodegradable and it contains approximately 2% hyaluronic acid (w/w) examinations such as ultrasound and/or MRI might be required to provide additional and 98% water. The rate of degradation of Macrolane in the body varies between diagnostic information. I have also been instructed that during self examination of the individuals. After the first treatment, additional injections of Macrolane gel may be breast the texture of implanted Macrolane gel may be different from that of breast necessary to achieve and maintain the desired aesthetic result. 2. Macrolane is intended for breast enhancement, volume restoration and contouring of Unlike permanent breast implants where long-term follow up data have shown that the body surfaces. The choice between Macrolane VRF30 and Macrolane VRF20 depends implant does not increase the risk of breast cancer, such data are not yet available for on the doctor’s judgment and the area to be treated. Macrolane because the treatment is new and a smaller group of women have been treated.
3. The treatment consists of introducing a cannula through a small incision in the skin and injecting Macrolane in the desired areas. In order to avoid a possible risk of local product mobility, I have been advised to avoid massaging the treatment site or applying pressure to the area for 2-3 weeks after the 4. For this treatment, local anesthesia is required in the areas where Macrolane is going to injection. The use of supportive clothing during the same time may also be useful. In be injected. My doctor has informed me about the risks of local anesthesia. the case of breast treatment, I should also avoid activities that can be associated with excessive movements of the breasts such as jogging and jumping and avoid sleeping 5. I have been specifically informed of the following: After the treatment, some common on my stomach for 2-3 weeks. For breast treatment the use of supportive clothing such treatment-related reactions might occur. These reactions include redness, swelling, as sports bra is useful during the same time. I have been informed to keep the injection tenderness, pain, bruising or itching at the implant site. Typically these reactions occur site dry the first day after treatment to avoid a possible risk of infection.
in immediate connection to treatment and disappear spontaneously within one or two weeks, but some reactions can also appear later and remain longer and sometimes 6. I have been specifically informed that I should get in contact with my treating physician or other health care provider in case any post-treatment discomfort becomes As with any injection, bleeding at the puncture site can occur and this can be pronounced or prolonged, if such discomfort does not respond to over-the-counter readily treated. Patients who are using substances that affect coagulation, such as analgesics, if I develop a fever or other symptoms of infection in the post-treatment acetylsalicylic acid (aspirin) or anti-inflammatory drugs, may experience an increased period or if I develop other symptoms that I find alarming.
risk of bruising or bleeding. Scarring might also occur at the insertion site.
Local mobility or displacement of the injected material and lumps have been observed 7. In my personal case, it has been considered that this treatment is appropriate, although in the treated area. Leakage of material through the skin incision and leakage that there are other alternatives that could be indicated under different circumstances. I have leads to a collection of Macrolane at insertion site have also been observed. This can been informed that individual variability exists regarding duration and that an individual be prevented by following the post-treatment care instructions including the use of treatment program needs to be established to maintain the effect long-term. I have had supportive clothing such as sports bra.
the opportunity to discuss with my doctor about these alternatives and the advantages, I have been advised that, as with any such procedure, injection of Macrolane is drawbacks and possible risks of the chosen treatment.
associated with a risk of infection. Soft tissue infections following injection treatment have been reported. Symptoms may include any combination of pain, redness, swelling I have informed my doctor about all my clinical data such as allergies, previous and and fever. Treatment, including antibiotics and in pronounced cases removal of the current illnesses and conditions including bleeding disorders as well as previous injected material, may be required. Symptoms of inflammation including a combination and current treatments and medications. I have also informed my doctor about any of pain, redness and swelling have also been reported. Decrease/increase in nipple treatments with other materials that I have had in the areas that are going to be treated.
sensation was reported in a clinical study, but no treatment was required for these events. Currently, I confirm that I am not pregnant or breast-feeding.
I have been informed that there is a low risk of the material being inadvertently injected into blood vessels, which could lead to damage to surrounding tissue. As with any Other risks and complications that can occur because of my personal circumstances injection there is also a low risk that e.g. nerves, vessels and viscera close to the It has been explained to me that encapsulation of Macrolane occurs, similar to permanent implants, as part of the healing process. The encapsulation can sometimes contract leading to symptoms of pain and/or more rounded breasts. These contractures, reported in clinical studies and via post market complaints, require manual rupture if they become symptomatic or puncture with a needle or in very rare cases release by surgery.
I have understood all the explanations which were given in an easy and clear language and my doctor has given me the opportunity to have any questions answered to my satisfaction. I also understand that at any moment and without giving any reason I can withdraw this consent to any further treatments. I am satisfied with the received information and I understand the significance and risks of this treatment.
Given the information and conditions above, I consent to being treated with Macrolane™ VRF 20 and/or Macrolane™ VRF 30.
REVOCATION OF THE CONSENT OF THE TREATMENT WITH MACROLANE™ VRF20 and MACROLANE™ VRF30 FIRST AND SURNAME OF THE PATIENT’S LEGAL REPRESENTATIVE LEGAL REPRESENTATIVE, RELATIVE, LEGAL GUARDIAN) I withdraw my consent to any treatments not already undertaken at this time of withdrawal. Labels from used Macrolane™ VRF syringes: 15-60000-08. Macrolane™ is a trademark of Q-Med AB. All rights reserved.

Source: http://www.macrolane.es/Documents/Practitioner%20site/Macrolane/Consumer/Forms/Macrolane%20Patient%20Consent%20Form.pdf