• GlutealArmonic® is intended for aesthetic or reconstructive volumetric augmentation of the gluteal area for patients of at least 18 years of age and is indicated:

    • To correct congenital or acquired gluteal deformities, or gluteal asymmetry
    • To enhance the aesthetic appearance of the gluteal area in patients that are dissatisfied with its size/shape
    • To correct or improve the result of a previous gluteal augmentation/reconstruction surgery

    For more information, please refer to your Directions for Use document received with your Motiva® product and our INFORMATION FOR THE PATIENT document.

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  • Because gluteal implant surgery is performed using general anesthesia, it is associated with the same risks as other invasive surgical procedures. After gluteal implant surgery, patients might experience the following over the first few weeks:

    • Swelling
    • Hardness
    • Discomfort
    • Itching
    • Bruising
    • Twinges
    • Pain over the first few weeks

    Potential adverse events that may occur with silicone gel-filled gluteal implant surgery include:

    • Wound dehiscence
    • Hematoma
    • Seroma or edema in the implantation area
    • Infection
    • Loss of the implant as a result of muscle dehiscence and implant extrusion/exposure
    • Ptosis
    • Implant rupture
    • Capsular contracture
    • Sciatic paresthesias

    Because gluteal implant surgery is performed using general anesthesia, it is associated with the same risks as other invasive surgical procedures.
    After gluteal implant surgery, patients might experience swelling, hardness, discomfort, itching, bruising, twinges and pain over the first few weeks.
    Potential adverse events that may occur with silicone gel-filled gluteal implant surgery include: wound dehiscence, hematoma, seroma or edema in the implantation area, infection, loss of the implant as a result of muscle dehiscence and implant extrusion/exposure, ptosis, implant rupture, capsular contracture, sciatic paresthesias ) and others. Talk to your doctor about other complications.

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  • GlutealArmonic® implants are not lifetime devices. However, the life expectancy of a silicone gluteal implant cannot be precisely estimated, as there are many factors beyond the manufacturer´s control that can affect the longevity of a device. The time period varies from patient to patient. Some patients could need replacement surgery few years after the primary procedure while others can have their implants intact for 10 years or longer. Therefore, the life expectancy of the implant cannot be guaranteed. For safety, as well as the most beautiful and healthy outcome, it is important that the patient returns to their plastic surgeon's office for follow-up evaluation every month within six months after the surgical procedure and yearly for the first 10 years. During the 10-year follow-up visit the surgeon will assess whether or not it is advisable to remove and replace the implants.

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  • Your recovery process depends on your individual case specifics and other variables. Adequately specifying a time frame of recovery is up to your surgeon. Below is brief, general information on what recovery might look like:

    • During the first 48 hours after surgery, you might have an elevated body temperature and your breasts may remain swollen and sensitive to physical contact for a month or longer. Both should fade away over time.
    • You are likely to feel tired and sore for several days following the operation.
    • You could experience a feeling of tightness in the breast area as the skin adjusts to the new breast size.
    • You should avoid any strenuous activities for at least a couple of weeks but should be able to return to work within a few days. Breast massage may also be recommended as appropriate (do not massage the area unless your surgeon specifically tells you to do so).

    For more information, please refer to your Directions for Use document received with your Motiva®Implants product and our INFORMATION FOR THE PATIENT document.

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