INFORMATION FOR PATIENTS

General requirements for use Los Deline™

Before you make the decision to have plastic contouring with Los Deline™, please take the time to consider some important factors:

FACILITY REQUIREMENTS
Injectable procedures with the use of Los Deline™ should only be undertaken in licensed and accredited medical institutions specially equipped premises (or in the operating room for mini-invasive interventions), providing for the intervention through the skin. Compliance with sterility is a very important condition for preventing complications and adverse reactions. It is important that the clinic can provide assistance and follow-up observation after the procedure.

QUALIFICATIONS OF MEDICAL PERSONNEL
Only certified specialists, who have appropriate qualification in compliance with local regulations and have passed special instructional courses on work with Los Deline™, must perform the aesthetic contouring procedures with usage of injectable volumizing implant Los Deline™.

PROPER PATIENT SELECTION
Proper selection of patients for injection plastic procedures of face and body is an important factor in achieving optimal and stable clinical results. Los Deline™ should be applied in strict accordance with the indications. Los Deline™ is prohibited for use in cases of contraindications. Anatomical and physiological characteristics of a patient can make for impossibility to achieve adequate aesthetic result and therefore the patient may not be satisfied with the result of the procedure.

CHECKING PRODUCT’S ORIGINALITY (ONLINE VERIFICATION)
Before the procedure, patient and Doctor must verify the product certificate by visiting Verification ID system located on www.losdeline.com.

Make an informed decision

WHO CAN BE LOS DELINE™ PATIENT?
• a person minimum age 18 and above
• patients must be in good health (a person should not have any autoimmune diseases, acute inflammatory disease, any kind of coagulopathy, malignant soft tissue diseases of any localization)
• patient should not have intolerability or allergy to medicines
• in a case of breast contouring it is necessary that the period after finishing of breast feeding is more than 6 months
• patient should have realistic expectations from the application of injectable implant.

Los Deline™ product is not to be applied in case of contraindications related to general diseases or local pathological processes if there is a risk of some adverse events/effects or complications. Your Doctor should acquaint you with the existing contraindications and alternative methods of plastic contouring, such as breast implants or fat grafting.

Consultation and Consent form

An important consideration for your satisfaction, is an open dialogue with your doctor regarding the benefits and possible risks of minimally invasive plastic contouring procedures. Ask your Doctor all the questions you are interested in.

During the consultation, the Doctor will ask you a series of questions about your health. Information on existing or transferred diseases can indicate the presence of contraindications to the procedure. After reviewing all the details, the Doctor will recommend the best version of the contouring procedure. In some cases, the Doctor’s advice may not coincide with the wishes of the patient, for example, when a woman wants a large size of the breast, but a small chest or tight covering tissues does not allow to do so.

As part of your decision, both you and your Doctor should sign Los Deline™ “Patient Informed Consent for Plastic Contouring Procedure” form. By signing the informed consent, you confirm that your choice of contouring procedure with the help of an injectable implant Los Deline™, is conscious, you are familiar with the possible risks and benefits of this type of plastic surgery.

Informed-consent documents are used to communicate information about the proposed treatment of a disease or condition along with disclosure of risks and alternative forms of treatment. The informed-consent process attempts to define principles of risk disclosure that should generally meet the needs of most patients in most circumstances. However, informed-consent documents should not be considered all-inclusive in defining other methods of care and risks encountered. Your Doctor may provide you with additional or different information that is based on all the facts in your particular case and the current state of medical knowledge.

Possible risks of minimally invasive plastic contouring with Los Deline™

Adverse reactions and complications could be caused by any procedure, using any medical product. As a rule, the application of Los Deline™ is characterized by good tolerance and low level of adverse reactions. However, in some cases, adverse reactions/effects might be experienced.

Possible adverse reactions: General weakness, Headache, Mild pyrexia, Fever, General malaise, Redness, Hematoma, Local edema, Local pain, Local skin dysesthesia, Local non-infected inflammation, Local infected inflammation, Gel fragmentation, Gel dislocation, Skin irregularities, Soft tissue asymmetry, Uneven gel distribution.

The compliance with all principles, standards and recommendations for manipulation, the right patient choice, and the correct techniques of injection procedures are important factor in preventing the emergence of adverse reactions.

Karlovo náměstí 17,
120 00 Prague 2
Czech Republic
phone: +420 228 226 171
mail: info@losdeline.com

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