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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 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.

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.

MOTIVA^® ROUND IMPLANTS provide a higher upper pole for a fuller-bodied, youthful appearance. Round implants are the most common implant shape, and are used in almost 80 percent of all breast augmentation surgeries.

ANATOMICAL TRUEFIXATION^® is designed to simulate the shape of a natural breast (i.e. a teardrop shape). As the only smooth anatomical implant on the market, this implant comes with fixation tabs to keep the implant in place, as well as radiopaque orientation lines and dots to guide the surgeon during placement and to verify implant position during X-ray.

ERGONOMIX^® contains our proprietary gel known as Ultima^®, which allows the implant to follow a women’s natural shape, holding a round profile when lying down and a teardrop when standing. This provides a very natural appearance and feel, especially during movement.

The implant projections we offer range from Mini to Corsé. Mini refers to our lowest projection, and Corsé our fullest/highest projection. Learn more about our projections HERE and select an implant type to find out in which projections they are available.

Please consult an experienced surgeon to discuss the Motiva^® implant type, volume, and projection that will achieve your desired results.

The American Academy of Pediatrics has stated that there is no reason why a woman with implants should refrain from nursing. However, breast implant surgery may interfere with how optimal breastfeeding may be, either by reducing or eliminating milk production.

Most women with breast implants who attempt nursing have successfully breastfed their babies. It is not known if there are increased risks for a woman with breast implants or if the children of women with breast implants are more likely to have health problems.

Please inform your surgeon in advance of your procedure if you wish to have the option to breastfeed afterwards, as a surgical approach with this consideration may reduce the chance of breastfeeding difficulties.

The Motiva^® Implants that best produce a round aesthetic appearance are MOTIVA^® ROUND with ProgressiveGel^® Plus, which provides the highest projection and a complete filling of the upper pole.

However, it is important to discuss your goals and implant choices in consultation with your surgeon before assuming a certain implant type is the best option for you.

ERGONOMIX^® with ProgressiveGel Ultima^® are designed for women who want a breast implant that offers the most natural look and feel possible; one that even adapts to their natural movements.

However, it is important to discuss your goals and implant choices in consultation with your surgeon before assuming a certain implant type is the best option for you.

Please use our CENTER LOCATOR to find a local plastic surgeon/clinic with the appropriate training and credentials to use Motiva® products.

Breast implants are not lifetime devices. However, the life expectancy of a silicone breast implant cannot be precisely estimated or guaranteed, 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 within a few years after the primary procedure, while others can have their implants intact for 10 years or longer.

If you experience pain or a change in appearance, please see your surgeon. To safeguard your health and final aesthetic outcome, it is important that you return to your plastic surgeon’s office for the follow-up evaluations they prescribe. Yearly visits are recommended to verify the device’s integrity. During the 10-year follow-up visit, your surgeon should assess whether it is advisable to remove and replace your implants.

For more information, please refer to your Directions for Use document received with your Motiva^® 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.

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.

Yes, 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 select 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 your Directions for Use document received with your Motiva^® product and our INFORMATION FOR THE PATIENT document.

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.

Q Inside^® Safety Technology 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. Q Inside^® Safety Technology is magnetic resonance (MR) conditional, meaning that it is a device that is shown not to pose any hazards under specific magnetic resonance conditions.

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 Q Inside^® Safety Technology, MRI should be the first imaging method of choice.

Q Inside^® Safety Technology 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 Q Inside^® Safety Technology 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 radiologist should be informed of the presence of the microtransponder and that it is embedded in the interior of the breast implant in order to anticipate the presence of an imaging void artifact.

There are other technologies that may be used in addition to MRI and are recommended to 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

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

When clinically indicated, following an MRI scan with a second imaging modality (such as an ultrasound) may improve cancer detection accuracy, with or without the presence of Motiva Implants^® with Q Inside^® Safety Technology.

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

1. Open the MotivaImagine® app and go to “Register your Implants” or open the MOTIVAIMAGINE® WEBSITE and sign up with either your Facebook or Google account, or with your email address.
2. Fill your Personal Information as requested.
3. Read the terms and conditions by clicking on “I agree with Terms and Conditions”.
4. Agree with terms and conditions by clicking “Agree” at the end of the displayed text.
5. Complete the Medical Information as requested and click “Next”.
6. Complete the Implants Information.
7. Select your registration method and complete as requested. Option A: Serial Number (SN) or Option B: Electronic Serial Number (ESN)
8. Click “Submit” for the registration of your implant(s).
9. You will receive an e-mail confirming that your implant(s) have been registered successfully.

The picture below shows where the Electronic Serial Number (ESN), Serial number (SN) and online validation code (VC) are located on your Patient card.

To extend the coverage of your Motiva^® Implants, Motiva^® offers an Extended Warranty Program that applies to Motiva^® Implants through an additional fee to be covered by or on behalf of the patient during the first 90 days after the initial breast surgery as specified below.

• First-Year Free Coverage: For first-year free coverage, patients must register their Motiva^® Implants through the MOTIVAIMAGINE^® WEBSITE or the MotivaImagine^® app within the first 90 days after the initial breast surgery.
• 2Y Motiva Program. The 2-year extended warranty program applies to all Motiva^® Implants without Q Inside^® that have been registered in the MotivaImagine^® website or app when a non-refundable fee has been applied to enroll the patient in the program. Patients must register the implanted devices within the first 90 days after the initial breast surgery.
• 5Y Motiva Program. The 5-year extended warranty program applies to all Motiva Implants^® with Q Inside^® that have been registered in the MotivaImagine^® website or app when a non-refundable fee has been applied to enroll the patient in the program. Patients must register the implanted devices within the first 90 days after the initial breast surgery.

In addition to the replacement product, these programs will support you with financial assistance applicable to the cost of one revision surgery in the event of a warranty claim for rupture or capsular contracture (Baker Grades III and IV).

In addition to the replacement product, these programs will support you with financial assistance applicable to the cost of one revision surgery in the event of a warranty claim for rupture or capsular contracture (Baker Grades III and IV).

All Motiva Implants^® without Qid^® qualify for the extended 2Y Motiva programme, while all Motiva implants^® with Qid^® qualify for the expanded 5Y Motiva Program.

Motiva Implants^® silicone breast implants warranty shall not apply to any implantations performed without strict accordance to current product “Directions for Use, Sterile Silicone Breast Implants Motiva Implant Matrix” and accepted surgical procedures by appropriately qualified and licensed surgeons. Motiva Implants^® standard and extended warranty programs do not apply to cases of:

• Removal of intact implants for capsular contracture (Baker Grades I or II)
• Removal of intact implants for size alteration
• Removal of intact implants due to wrinkling or rippling
• Loss of shell integrity caused by or during re-operative procedures
• Loss of shell integrity resulting from open capsulotomy or closed compression capsulotomy procedures
• Loss of shell integrity resulting from sharp instrument damage
• Reconstructive surgery

Establishment Labs may exclude from the applicable warranty program patients with previous history of capsular contracture (Baker grades III and IV).