Motiva® Implants

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.

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.

Because breast implant surgery is more often performed using general anesthesia, it is associated with the same risks as other invasive surgical procedures. 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. Talk to your doctor about other complications.

The recovery process depends on the profile and other variables. During the first 48 hours, the patient might have an elevated body temperature, and the breasts may remain swollen and sensitive to physical contact for a month or longer. Both should fade away over time. The patient is likely to feel tired and sore for several days following the operation. They could experience a feeling of tightness in the breast area as the skin adjusts to the new breast size. They 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. 

The patient should inform the examiners about the presence, type, and placement of implants and  request a diagnostic mammography, rather than a screening mammography. 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.

It is recommended that gluteal implant surgery should not be performed in the following cases:


• Patients who have active infections anywhere in the body.
• Patients with uncontrolled diabetes due to a greater risk of infection and healing problems.
• Obese patients should not receive gluteal augmentation due to the higher-than-average risk of developing seromas that their weight may entail. Obesity increases the shear force (or positional stress) in the gluteal region, making the collection of fluids during recovery more likely.
• Patients who show tissue characteristics clinically incompatible with gluteoplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.
• Patients with any condition – or treatment – determined by the surgeon to constitute an unjustifiable surgical risk (e.g., unstable cardiovascular disease, coagulopathies, chronic pulmonary problems, etc.)

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.

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.

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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. 

Please find below all relevant information about our standard and extended warranties.

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.

Furthermore, we offer our Motiva Extended Warranty Programs, in which the patient may decide to participate according to your 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)

The patient pays a one-time fee of 100  USD (2Y) or 200 USD (5Y) and in case of a confirmed rupture/capsular contracture, she are entitled to a replacement unit and financial aid according to the costs of the revision surgery (up to 1000 or 2500 USD). Financial aid is the difference between an extended warranty and the basic warranty.

The patient has the option of purchasing this warranty - according to the implant type - within 90 days from the day of surgery. For more information, please read our Warranty Terms & Conditions at https://motiva.health/patients/product-warranty/.

May you have further questions, do not hesitate to contact us back.

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 you may decide to participate according to your 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).

Motiva® Warranties will not apply to any implantations performed without strict accordance with the then-current  Directions for Use and accepted surgical procedures by appropriately qualified, licensed surgeons.

Notwithstanding the foregoing, for the Extended Warranty Programs, the patient will still be eligible for financial assistance if she can demonstrate that noncompliance with the foregoing directions and procedures did not cause the warranty case at hand.

The First Year Free Coverage, 2Y Extended Warranty Program, and 5Y Warranty Program do not apply to:

• Revision surgery patients with a previous history of capsular contracture with other brands of breast implants different than Motiva®

• Removal of intact breast implants for capsular contracture grades I or II

• Removal of intact breast implants for size alteration

• Removal of intact breast implants due to wrinkling or rippling

• Loss of shell integrity caused by or during reoperative procedures

• Loss of shell integrity resulting from open capsulotomy or closed compression capsulotomy procedures

• Loss of shell integrity resulting from sharp instrument damage

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

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.

Motiva^® Implants are available with a radio-frequency identification (RFID) microtransponder embedded in the silicone gel known as the Qid^®. When interrogated by an external secure hand-held reader a unique electronic serial number (ESN) will be transmitted by the microtransponder. With this technology Motiva^® Implants assures that healthcare providers and patients have access to secure, non-invasive verification of the electronic serial number (ESN). This unique number can then be referenced back to the implant ’s serial number, manufacturer name, date of manufacture, implant style and volume. Furthermore the ESN codes can never be lost or misplaced, unlike product and warranty cards, providing a permanently readable code that ensures safety and well being in the event of any issue or device recall.

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.

MRI scanning is the imaging modality of choice for breast implant rupture surveillance or diagnosis. In the event of a suspected rupture in Motiva® Implants with Qid®, MRI should be the first imaging of choice. Qid® is a small and light device comprising an integrated circuit and ferrite coil/antenna assembly. Due to the presence of the ferrite, an MRI of Motiva® Implants with Qid® may produce in some of the imaging a small shadow, also known as an artifact, immediately behind the device. If a rupture is not found but still suspected to be present in this specific area, a second imaging modality, such as CT or ultrasound, should be employed.

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:

• Underlying physics of the energy-tissue interaction
• Data acquisition errors (e.g., patient movement during the test)
• Poor reconstructive algorithms (unable to properly represent the anatomy)
• Presence of metallic objects (orthopedic hardware, vascular ports, pacemakers).

Breast implants also commonly interfere with imaging examinations by creating shadows or voids that obscure some breast tissue as well and may cause complications in obtaining mammography of the entire breast. 

The radiologist should be informed of the presence of the microtransponder and that it is embedded in the interior of the breast implant. The presence of an imaging void artifact should be anticipated along with the expected size.

Motiva^® Implants are not yet commercially available in the US and are undergoing clinical investigation pursuant to US Food and Drug Administration (FDA) regulations for investigational medical devices.

Motiva^® Implants are CE marked, which means they comply with health, safety, and environmental protection standards for products sold in the European Economic Area (EEA). Currently, Motiva^® is approved for commercial distribution in more than 80 countries globally.

For more information, you can go to: US Trials