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^® Implants Breast implants are indicated for the following procedures in female patients

• • Breast augmentation for women of at least 18 years of age, 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.

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

Breast implant surgery should not be performed in women with the following conditions:

• Active infections anywhere in their body
• Existing carcinoma of the breast (without mastectomy)
• Advanced fibrocystic disease considered premalignant (without accompanying subcutaneous mastectomy)
• Any disease clinically known to impact wound-healing ability
• Tissue characteristics clinically incompatible with mammoplasty
• Currently ongoing pregnancy or breastfeeding
• Any condition – or treatment – determined by the surgeon to constitute an unjustifiable surgical risk

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

Breast implant surgery, which is often performed using general anesthesia, is associated with the same risks as other invasive surgical procedures. Complications vary from patient to patient. After breast implant surgery, patients may experience the following symptoms over the first few weeks:

• Swelling
• Hardness
• Discomfort
• Itching
• Bruising
• Pain

Additional potential adverse events that may occur after silicone gel-filled breast implant surgery also include:

• Capsular contracture
• Rupture
• Alterations in nipple and breast sensation
• Infection
• Hematoma/seroma
• Delayed wound healing
• Implant extrusion
• Necrosis
• Granuloma
• Breast tissue atrophy
• Lymphadenopathy
• Gel diffusion
• Gel fracture
• Anaplastic large cell lymphoma (ALCL)

If you are unfamiliar with the previously mentioned terminology and would like to learn more, please contact your surgeon.

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

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.

Breast implants may complicate the interpretation of mammographic images by obscuring underlying breast tissue and/or by compressing overlying tissue. Prior to any examination, you should inform your imaging technician about the presence, type, and placement of your implants and to request a diagnostic mammography, rather than a screening mammography. Accredited mammography centers, technicians with experience in examining patients with breast implants, and the use of displacement techniques are needed to adequately visualize breast tissue in the implanted breast. The current recommendations for pre-operative/screening mammograms are no different for women with breast implants than for women without implants. Pre- and post-surgical mammography may be performed to determine a baseline for future routine scanning in augmentation patients.

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

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.

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.

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.

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.

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

You 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 you are able to complete your registration. 

If you 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. 

All of our Motiva Implants have 2 standard warranties (the patient does not need to purchase them):
- Always Confident Warranty against rupture for the lifetime of the device
- Product replacement Policy against capsular contracture baker grade III and IV for a period of 10 years.

In the case the surgeon and our PMS department confirm a rupture or capsular contracture baker grade III or IV, the patient is entitled to a replacement unit at a 100% discount. The costs of the revision surgery are not covered by these standard warranties.

For more information, please read our Warranty Terms & Conditions at https://motiva.health/patients/product-warranty/.

Motiva^® offers an Extended Warranty Program that applies to qualifying Motiva^® Implants silicone breast implants, through an additional fee to be covered by or on behalf of the patient during de first 90 days after the initial breast surgery as specified below:

• First Year Free Coverage. For first-year coverage, patients must register their Motiva® silicone breast implants through our website or through the MotivaImagine® App within the first 90 days after the initial breast surgery. Patients with Qualified Qid® implants during this first year since implantation in addition to product replacement, in case of rupture or capsular contracture Baker grades III and IV cases, may also receive financial assistance per affected implant (up to 2500 USD) applicable to the cost of the revision surgery when complying with the terms, conditions and claim procedures available in our site and app.

• 2Y Extended Warranty Program. The Motiva® 2 year Extended Warranty Program applies only to the qualified SmoothSilk®/SilkSurface® Plus without Qid® and Ergonomix® implants without Qid® registered in the MotivaImagine® website and MotivaImagine® app when a non-refundable feed (100 USD) has been applied to enroll the patient in the program. Patients must register the implanted devices during the first 90 days after the initial breast surgery. For all registered products with our 2Y Motiva® Program, in addition to the replacement product patient may also receive financial assistance per affected implant (up to 1000 USD) applicable to the cost of the revision surgery for each impacted implant in the case of a warranty claim for rupture or capsular contracture Baker grades III and IV. When complying with the terms, conditions, and claim procedures available in MotivaImagine® Site and App.

• 5Y Extended Warranty Program. The Motiva® 5 year Extended Warranty Program applies only to the qualified SmoothSilk®/SilkSurface® Plus with Qid® and Ergonomix® implants with Qid® registered in the MotivaImagine® website and MotivaImagine® app when a non-refundable fee (200 USD) has been applied to enroll the patient in the program. Patients must register the implanted devices during the first 90 days after the initial breast surgery. For Motiva® Implants with Qid®, with our 5Y Motiva® Program, in addition to the replacement product customer may also receive financial assistance per impacted implant (up to 2500 USD) applicable to the cost of the revision surgery in the case of a warranty claim for rupture or capsular contracture Baker grades III and IV. When complying with the terms, conditions, and claim procedures available in the MotivaImagine® Site and App.

To make the purchase of the applicable extended warranty:

- Log into your MotivaImagine Account

- Go to 'Extend my warranty'

- Fill in your card details.

- Submit

We offer our Motiva Extended Warranty Programs, in which the patient may decide to participate according to their personal case:

- For Motiva Implants® without Q Inside Safety Technology™ our 2Y Motiva Program™ (2 years coverage)
- For Motiva Implants® with Q Inside Safety Technology™ our 5Y Motiva Program™ (5 years coverage)

Sidenote:

There is no option to switch between warranties (example 5Y for implants without Q and vice versa).

Qid^® is the world’s first microtransponder for clinical use in a breast implant. It is the only transponder with a 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 (FDA) cleared it for use in 2004. Qid^® 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.

Qid^® 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 on cards can be lost or misplaced. With its unique ESN permanently located within the breast implant, Qid^® provides the confidence of instant implant traceability and verification.

A radio frequency identification (RFID) microtransponder (Qid®) is a passive component (without a battery)  placed in the gel that provides each implant device with a unique electronic serial number which is only accessible through the use of a handheld scanner specific to Motiva. The Electronic serial number does not contain patient-specific or identifiable information,  only device-specific information such as the manufacturing date, serial number, lot number, implant volume, size and projection, model and surface type). 

 The Qid is 9mm in length.

The components of the Qid® are:

• Copper Polystermide Estersol 180 wire,
• Nickel-Zinc Ferrite core,
• Photobond4442 Acrylate adhesive,
• 4305 Application Specific Integrated Circuit (ASIC),
• and Soda-lime Silicate glass.

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

MRI scanning is the imaging modality of choice for breast implant rupture surveillance or diagnosis. In the event of a suspected rupture of a Motiva^® implant with Qid^®, MRI should be the first imaging method of choice.

Qid^® is a small, light device comprised of an integrated circuit and ferrite coil/antenna assembly. Due to the presence of the ferrite, an MRI of Motiva^® Implants with Qid^® may produce a shadow, known as an artifact, immediately behind the device. If a rupture is not found but is suspected in this specific area, a second imaging modality (such as ultrasound, tomosynthesis, digital compression mammography, subtraction contrast mammography, and/or scintimammography) may be used to better visualize the obstructed region.

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

Artifacts are commonplace in MRI and may cause visualization challenges when reading tissue structures. Artifacts may be present as shadows, distortions or voids within the imaging field and can be caused by a variety of phenomena such as:

• The underlying physics of the energy-tissue interaction
• Possible data acquisition errors (e.g., the patient moved during scanning)
• Presence of metallic objects (orthopedic hardware, vascular ports, pacemakers)

Breast implants themselves may interfere with imaging by creating shadows or voids, which obscure areas of tissue within the breast and create difficulties in obtaining a clear mammography of the entire breast. If you are unfamiliar with the previously mentioned terminology and would like to learn more, please contact your doctor and/or surgeon.

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

The microtransponder (Qid®) is MRI-safe. The device is “MRI conditional”, meaning that it has been demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use.

Qid® may create an imaging void during MRI (known as an artifact effect) that can block visualization of a small area of minor breast tissue near it. In special cases, alternative imaging techniques such as ultrasound, tomosynthesis, digital compression mammography, subtraction contrast mammography, and/or scintimammography can be used to better visualize the region obstructed by Qid®.

For more information, please refer to the attached documents 'Qid facts for surgeons and radiologists'.

The risks associated with the microtransponder include the following:

• Adverse tissue reaction
• Migration of the transponder
• Failure of the microtransponder to operate properly
• Failure of the inserter
• Failure of the electrical scanner
• Electromagnetic interference
• Electrical hazards
• MRI disturbances

These risks have been mitigated through the establishment of certain testing requirements by the FDA for this device, including the requirement to perform biocompatibility testing, migration testing, performance testing, electromagnetic compatibility testing, electrical safety testing, and MRI compatibility testing.

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: Three-Year Clinical Data. Aesthet Surg J. 2024 sjae134, doi.org/10.1093/asj/sjae138

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.

Information about our products is available online at MOTIVA.HEALTH

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

We manufacture Motiva Implants, but we don’t do any surgeries. 

Surgeons worldwide are using our implants. Here's a link to our Center locator, where certified surgeons who use Motiva Implants are listed in your requested region: https://motiva.health/app/center-locator/.

We suggest that the patient makes an appointment with one or more of them to discuss the desired result and Motiva options.