Motiva® Implants

A strategic decision has been made to discontinue the production and future availability of our 1050 and 1060 cc implants. This decision is part of our commitment to refining our product portfolio and ensuring the sustained excellence of our offerings. We understand the impact this may have and apologize for any inconvenience. Patients who previously had surgery with 1050/1060 cc do not need to be worried. The current product safety is not compromised with this decision. Please find attached the official communication.

Motiva breast implants are indicated for the following procedures in female patients:

•Breast augmentation for women at least 18 years old, including previous augmentation to increase the breast size and revision surgery to correct or improve the result of a previous breast augmentation surgery.
•Breast Reconstruction, including previous reconstruction to replace breast tissue that has been removed due to cancer or trauma, or that has failed to develop properly due to a severe breast anomaly, as well as revision surgery to correct or improve the results of a previous breast reconstruction surgery.

Reference:
Establishment Labs. DOC:002: Directions for Use Establishment Labs Sterile Silicone Breast Implants Motiva Implant Matrix®. Data on file.

Information about our products is available online at MOTIVA.HEALTH

Implants overview: https://motiva.health/patients-implant-overview/

Breast implant surgery should not be performed in women with active infections anywhere in their body, existing carcinoma of the breast (without mastectomy), with advanced fibrocystic disease considered premalignant (without accompanying subcutaneous mastectomy), any disease clinically known to impact wound-healing ability, tissue characteristics clinically incompatible with mammoplasty, any condition – or treatment – determined by the surgeon to constitute an unjustifiable surgical risk, and in women who are currently pregnant or nursing.
 

Reference:
Establishment Labs. DOC:002: Directions for Use Establishment Labs Sterile Silicone Breast Implants Motiva Implant Matrix®. Data on file.

After breast 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 breast implant surgery include capsular contracture, rupture, changes in nipple and breast sensation, infection, hematoma/seroma, delayed wound healing, implant extrusion, necrosis, granuloma, breast tissue atrophy/chest wall deformity, lymphadenopathy, gel diffusion, gel fracture, breast implant associated anaplastic large cell lymphoma (BIA-ALCL) and others. 

The patient should inform the examiners about the presence, type, and placement of implants. Breast implants may complicate the interpretation of mammographic images by obscuring underlying breast tissue and/ or by compressing overlying tissue. Accredited mammography centers, technicians with experience in examining patients with breast implants, and the use of displacement techniques are needed to visualize breast tissue in the implanted breast adequately. The current recommendations for preoperative/screening mammograms are no different for women with breast implants than for those women without implants. Pre and post-surgical mammography may be performed to determine a baseline for routine future studies in augmentation patients.

Reference:
Establishment Labs. DOC:002: Directions for Use Establishment Labs Sterile Silicone Breast Implants Motiva Implant Matrix®. Data on file.

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

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:
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:
Establishment Labs. DOC-013: Directions For Use Establishment Labs Sterile Silicone Body Contour Implants Motiva Implants® Glutealarmonic. Data on file.

The pictures below show where the Electronic Serial Number (ESN), Serial Number (SN) and Validation Code (VC) are located depending on the Patient Card.

Breast implant cards

Gluteal implants cards

ONLY FOR BRAZIL

In order to register implants, please go to https://motiva.health/motivaImagine/ and create/log into your account.

The patient can use either the Serial Number (SN) and the Validation Code (VC) OR the Electronic Serial Number (ESN). You don’t need both. Some Motiva implants do not have an ESN number, given that they do not have the Qid microtransponder technology in them. This is completely okay, as you can still register them using the SN and VC.
 

The SN has 10 digits in the format is 00000000-00. Remember that each SN is unique. If you use the SN, you also need the VC, which is the number or letter that you can find on the right of your sticker.

The format of the ESN is 15 digits and, usually, it starts with 9.

Please refer to this image where to find it.

​

Please try again considering these tips, and let us know if they are able to complete the registration. 

If they have any additional issues, please send us a picture of the implant card and a video of the  process to be able to help you. 

Below you will find a clear overview of all Motiva® warranty options.

Standard Warranties (OUS before March 1, 2026)

According to the Motiva® Breast Implants Warranty and Product Replacement Policy: Terms and Conditions, all Motiva® implants include two standard warranties at no cost for the patient:

-Always Confident Warranty:

Against implant rupture for the lifetime of the device

-Product replacement Policy:

Coverage for capsular contracture (Baker Grade III and IV) for 10 years from the date of the original surgery.

Extended Warranties and Programs

Additional coverage options are available depending on the implant type (with or without RFID technology—Qid® or Zen®—and other criteria). Eligibility depends on the specific product, warranty length, country or region, date of claim, and whether the implant was registered within 90 days of the initial surgery.

-First Year Free Coverage:

• For Motiva Implants® with RFID technology (Qid® or Zen®)
• Registration within 90 days
• No costCoverage: product replacement + financial assistance

-2Y Extended Warranty Program™ (2 years coverage)

• For Motiva Implants® without RFID technology (Qid® or Zen®)
• Registration within 90 days
• One-time USD 100 fee
• Coverage: product replacement + financial assistance

-5Y Extended Warranty Program™ (5 years coverage)

• Motiva Implants® with RFID technology (Qid® or Zen®) or Ergonomix2® *                               
• Registration within 90 days
• Cost applies for RFID implants; free for Ergonomix2®
• Coverage: product replacement + financial assistance

-Mia® Comprehensive Coverage

• Motiva Implants Ergonomix2® Diamond                             
• Registration is required within the first 90 days after initial surgery
• No additional cost
• Coverage: product replacements + financial assistance

-Woman’s Choice Program (WCP):

• For Motiva Implants Ergonomix2® &  Ergonomix2® Diamond                             
• Registration within 90 days
• No cost
• Coverage: financial assistance only

Important Notes

• All events must be reviewed and confirmed by our Post-Market Surveillance (PMS) team and must meet the conditions outlined in the warranty terms.
• Each warranty program has specific benefits, requirements, and exclusions.
• Sidenote[AC1] : There is no option to switch between warranties (example 5Y for implants without Q and vice versa).

For complete details, please review our Warranty Terms & Conditions at:  https://motiva.health/patients/product-warranty/.

If you have any questions, please feel free to contact us.

Below you will find a clear overview of all Motiva® warranty options.

Standard Warranties (OUS before March 1, 2026)

According to the Motiva® Breast Implants Warranty and Product Replacement Policy: Terms and Conditions, all Motiva® implants include two standard warranties at no cost for the patient:

-Always Confident Warranty:

Against implant rupture for the lifetime of the device

-Product replacement Policy:

Coverage for capsular contracture (Baker Grade III and IV) for 10 years from the date of the original surgery.

Extended Warranties and Programs

Additional coverage options are available depending on the implant type (with or without RFID technology—Qid® or Zen®—and other criteria). Eligibility depends on the specific product, warranty length, country or region, date of claim, and whether the implant was registered within 90 days of the initial surgery.

-First Year Free Coverage:

• For Motiva Implants® with RFID technology (Qid® or Zen®)
• Registration within 90 days
• No costCoverage: product replacement + financial assistance

-2Y Extended Warranty Program™ (2 years coverage)

• For Motiva Implants® without RFID technology (Qid® or Zen®)
• Registration within 90 days
• One-time USD 100 fee
• Coverage: product replacement + financial assistance

-5Y Extended Warranty Program™ (5 years coverage)

• Motiva Implants® with RFID technology (Qid® or Zen®) or Ergonomix2® *                               
• Registration within 90 days
• Cost applies for RFID implants; free for Ergonomix2®
• Coverage: product replacement + financial assistance

-Mia® Comprehensive Coverage

• Motiva Implants Ergonomix2® Diamond                             
• Registration is required within the first 90 days after initial surgery
• No additional cost
• Coverage: product replacements + financial assistance

-Woman’s Choice Program (WCP):

• For Motiva Implants Ergonomix2® &  Ergonomix2® Diamond                             
• Registration within 90 days
• No cost
• Coverage: financial assistance only

Important Notes

• All events must be reviewed and confirmed by our Post-Market Surveillance (PMS) team and must meet the conditions outlined in the warranty terms.
• Each warranty program has specific benefits, requirements, and exclusions.
• Sidenote[AC1] : There is no option to switch between warranties (example 5Y for implants without Q and vice versa).

For complete details, please review our Warranty Terms & Conditions at:  https://motiva.health/patients/product-warranty/.

If you have any questions, please feel free to contact us.

Below you will find a clear overview of all Motiva® warranty options.

Standard Warranties (OUS before March 1, 2026)

According to the Motiva® Breast Implants Warranty and Product Replacement Policy: Terms and Conditions, all Motiva® implants include two standard warranties at no cost for the patient:

-Always Confident Warranty:

Against implant rupture for the lifetime of the device

-Product replacement Policy:

Coverage for capsular contracture (Baker Grade III and IV) for 10 years from the date of the original surgery.

Extended Warranties and Programs

Additional coverage options are available depending on the implant type (with or without RFID technology—Qid® or Zen®—and other criteria). Eligibility depends on the specific product, warranty length, country or region, date of claim, and whether the implant was registered within 90 days of the initial surgery.

-First Year Free Coverage:

• For Motiva Implants® with RFID technology (Qid® or Zen®)
• Registration within 90 days
• No costCoverage: product replacement + financial assistance

-2Y Extended Warranty Program™ (2 years coverage)

• For Motiva Implants® without RFID technology (Qid® or Zen®)
• Registration within 90 days
• One-time USD 100 fee
• Coverage: product replacement + financial assistance

-5Y Extended Warranty Program™ (5 years coverage)

• Motiva Implants® with RFID technology (Qid® or Zen®) or Ergonomix2® *                               
• Registration within 90 days
• Cost applies for RFID implants; free for Ergonomix2®
• Coverage: product replacement + financial assistance

-Mia® Comprehensive Coverage

• Motiva Implants Ergonomix2® Diamond                             
• Registration is required within the first 90 days after initial surgery
• No additional cost
• Coverage: product replacements + financial assistance

-Woman’s Choice Program (WCP):

• For Motiva Implants Ergonomix2® &  Ergonomix2® Diamond                             
• Registration within 90 days
• No cost
• Coverage: financial assistance only

Important Notes

• All events must be reviewed and confirmed by our Post-Market Surveillance (PMS) team and must meet the conditions outlined in the warranty terms.
• Each warranty program has specific benefits, requirements, and exclusions.
• Sidenote[AC1] : There is no option to switch between warranties (example 5Y for implants without Q and vice versa).

For complete details, please review our Warranty Terms & Conditions at:  https://motiva.health/patients/product-warranty/.

If you have any questions, please feel free to contact us.

Below you will find a clear overview of all Motiva® warranty options.

Standard Warranties (OUS before March 1, 2026)

According to the Motiva® Breast Implants Warranty and Product Replacement Policy: Terms and Conditions, all Motiva® implants include two standard warranties at no cost for the patient:

-Always Confident Warranty:

Against implant rupture for the lifetime of the device

-Product replacement Policy:

Coverage for capsular contracture (Baker Grade III and IV) for 10 years from the date of the original surgery.

Extended Warranties and Programs

Additional coverage options are available depending on the implant type (with or without RFID technology—Qid® or Zen®—and other criteria). Eligibility depends on the specific product, warranty length, country or region, date of claim, and whether the implant was registered within 90 days of the initial surgery.

-First Year Free Coverage:

• For Motiva Implants® with RFID technology (Qid® or Zen®)
• Registration within 90 days
• No costCoverage: product replacement + financial assistance

-2Y Extended Warranty Program™ (2 years coverage)

• For Motiva Implants® without RFID technology (Qid® or Zen®)
• Registration within 90 days
• One-time USD 100 fee
• Coverage: product replacement + financial assistance

-5Y Extended Warranty Program™ (5 years coverage)

• Motiva Implants® with RFID technology (Qid® or Zen®) or Ergonomix2® *                               
• Registration within 90 days
• Cost applies for RFID implants; free for Ergonomix2®
• Coverage: product replacement + financial assistance

-Mia® Comprehensive Coverage

• Motiva Implants Ergonomix2® Diamond                             
• Registration is required within the first 90 days after initial surgery
• No additional cost
• Coverage: product replacements + financial assistance

-Woman’s Choice Program (WCP):

• For Motiva Implants Ergonomix2® &  Ergonomix2® Diamond                             
• Registration within 90 days
• No cost
• Coverage: financial assistance only

Important Notes

• All events must be reviewed and confirmed by our Post-Market Surveillance (PMS) team and must meet the conditions outlined in the warranty terms.
• Each warranty program has specific benefits, requirements, and exclusions.
• Sidenote[AC1] : There is no option to switch between warranties (example 5Y for implants without Q and vice versa).

For complete details, please review our Warranty Terms & Conditions at:  https://motiva.health/patients/product-warranty/.

If you have any questions, please feel free to contact us.

Below you will find a clear overview of all Motiva® warranty options.

Standard Warranties (OUS before March 1, 2026)

According to the Motiva® Breast Implants Warranty and Product Replacement Policy: Terms and Conditions, all Motiva® implants include two standard warranties at no cost for the patient:

-Always Confident Warranty:

Against implant rupture for the lifetime of the device

-Product replacement Policy:

Coverage for capsular contracture (Baker Grade III and IV) for 10 years from the date of the original surgery.

Extended Warranties and Programs

Additional coverage options are available depending on the implant type (with or without RFID technology—Qid® or Zen®—and other criteria). Eligibility depends on the specific product, warranty length, country or region, date of claim, and whether the implant was registered within 90 days of the initial surgery.

-First Year Free Coverage:

• For Motiva Implants® with RFID technology (Qid® or Zen®)
• Registration within 90 days
• No costCoverage: product replacement + financial assistance

-2Y Extended Warranty Program™ (2 years coverage)

• For Motiva Implants® without RFID technology (Qid® or Zen®)
• Registration within 90 days
• One-time USD 100 fee
• Coverage: product replacement + financial assistance

-5Y Extended Warranty Program™ (5 years coverage)

• Motiva Implants® with RFID technology (Qid® or Zen®) or Ergonomix2® *                               
• Registration within 90 days
• Cost applies for RFID implants; free for Ergonomix2®
• Coverage: product replacement + financial assistance

-Mia® Comprehensive Coverage

• Motiva Implants Ergonomix2® Diamond                             
• Registration is required within the first 90 days after initial surgery
• No additional cost
• Coverage: product replacements + financial assistance

-Woman’s Choice Program (WCP):

• For Motiva Implants Ergonomix2® &  Ergonomix2® Diamond                             
• Registration within 90 days
• No cost
• Coverage: financial assistance only

Important Notes

• All events must be reviewed and confirmed by our Post-Market Surveillance (PMS) team and must meet the conditions outlined in the warranty terms.
• Each warranty program has specific benefits, requirements, and exclusions.
• Sidenote[AC1] : There is no option to switch between warranties (example 5Y for implants without Q and vice versa).

For complete details, please review our Warranty Terms & Conditions at:  https://motiva.health/patients/product-warranty/.

If you have any questions, please feel free to contact us.

Currently, MRI imaging is the preferred method of choice for identification of implant rupture in breast implant evaluation. However, there are other technologies that may be used in addition to MRI and are recommended complement visualization and improve overall diagnosis. Additional imaging modalities to be considered include the following:

• Breast ultrasound.
• Digital tomosynthesis.
• Automated ultrasound.
• Scintimammography.
• Dual energy contrast subtraction digital mammography.
• Dual-energy enhanced mammography.

Q Inside® Safety Technology is the world’s first micro transponder for clinical use in a breast implant. It is the only transponder with CE mark (which indicates compliance with the health, safety, and environmental protection standards for products sold in the European Economic Area), and the United States Food & Drug Administration (F.D.A.) cleared it for use in 2004. Q Inside® is placed in the gel filling inside Motiva Implants®.

A handheld reader is used to externally scan the transponder, providing an electronic serial number (ESN) that can be used to retrieve important implant information such as manufacturing date, implant type, volume, and more.

Q Inside® is an optional feature in Motiva Implants® that is particularly useful to patients and surgeons to identify the implant type after the surgery, and to verify implant details during the event of a product recall.

Product information or warranty cards can be lost or misplaced. With its unique ESN permanently located within the breast implant, Q Inside® provides the confidence of instant implant traceability and verification.

Qid^® does not pose any safety concerns for patients. It has been proven to be both safe and effective. Activated externally by the reader, it doesn’t require a battery and has an indefinite life expectancy. Qid^® is magnetic resonance (MR) conditional, meaning that it is a device that is shown not to pose any hazards under specific magnetic resonance conditions.

Please see the attached documents for more information:

- Qid facts for the surgeon

- Qid facts for radiologists

Yes, Motiva Implants^®* are FDA approved with less than 1% device related-complications¹.

Reference:
1. Glicksman C, Wolfe A, McGuire P. The study of the safety and effectiveness of Motiva SmoothSilk silicone gel-filled breast implants in patients undergoing primary and revisional breast augmentation: 5-year clinical data. Aesthet Surg J. 2025;(sjaf245). doi:10.1093/asj/sjaf245

Disclaimer:
*Motiva SmoothSilk^® Round and Motiva SmoothSilk Ergonomix^® implants have received Premarket Approval (PMA) from the Food and Drug Administration (FDA) for Augmentation Indication, and are commercially available in the US.
Motiva Implants^® for Reconstruction Indication are not yet commercially available in the US and are undergoing clinical investigation pursuant to FDA regulations for investigational medical devices.