GlutealArmonic®
-
GlutealArmonic® are intended to be used in women aged at least 18 years old for primary and revision gluteal augmentation/reconstruction purposes, indicated for the following procedures:
• To correct congenital or acquired gluteal deformities or gluteal asymmetry.
• To enhance the aesthetical appearance in patients dissatisfied with the shape/size of
their gluteal area.
• To correct or improve the result of a previous gluteal augmentation/reconstruction surgery.Reference:
Establishment Labs. DOC-013: Directions For Use Establishment Labs Sterile Silicone Body Contour Implants Motiva Implants® Glutealarmonic. Data on file
Learn more -
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.Reference:
Learn more
Establishment Labs. DOC-013: Directions For Use Establishment Labs Sterile Silicone Body Contour Implants Motiva Implants® Glutealarmonic. Data on file. -
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 may need replacement surgery a 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.
Reference:
Learn more
Establishment Labs. DOC-013: Directions For Use Establishment Labs Sterile Silicone Body Contour Implants Motiva Implants® Glutealarmonic. Data on file.