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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.

The radiologist and/or radiology technician should be informed of the presence of the Qid^®, a ferrite microtransponder, notifying them that it is embedded in the posterior part of the device near the patch of the breast implant.¹ This will allow the professional to anticipate the presence and accurately manage an imaging artifact with certain MRI techniques (see next question for further guidance).² Additionally, sharing information about the style of the breast implants (e.g., saline or silicone-filled and single or multiple lumen implants) is critical during the interpretation of imaging surveillance tests, such as MRI and ultrasound.

The Qid^® micro transponder itself does not pose any safety concerns for patients. It has been clinically proven to be both safe and effective when activated externally by the reader and has an indefinite life expectancy. Additionally, the Motiva Implants^® with Qid^® are magnetic resonance (MR) conditional, meaning that it is a device that is shown not to pose any hazards under specific magnetic resonance conditions.³

The Qid^® is a small, light device comprising of an integrated circuit and ferrite coil/antenna assembly.¹ Due to the presence of the ferrite, MR images of Motiva Implants^® with Qid^® may produce a shadow, known as an artifact, in the area around the device.³ 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.^2,4,5

Artifacts are commonplace in MRI and in many specialities. Artifacts and may cause visualization challenges when reading tissue structures and can present as shadows, distortions, or voids within the imaging field.^2,6 They can be caused by a variety of phenomena such as:

• Sample artifacts caused by the patient or foreign bodies (e.g.: orthopedic hardware, breast implants, vascular ports, pacemakers, and in the case of the Motiva Implants^®, the Qid^® due to the ferrite component).
• Sequence artifacts caused by the imaging acquisition process.
• System artifacts caused by hardware, software or environment.

General recommendations include the following:⁷

• Utilization of an MRI system with 1.5 Tesla or 3 Tesla field strength, only
• Placing the patient in a prone position during imaging with a bilateral breast evaluation for assessment of symmetry and parenchymal enhancement
• Utilization of a dedicated breast MRI coil to acquire the images
• For contrast-enhanced breast MRI, gadolinium should be used as the contrast medium at a concentration of 0.1 mmol/kg followed by a saline flush that is at minimum 10 cc
• Ensure the field of view is covering the highest possible spatial resolution to maintain adequate anatomical coverage. Ideally, the field of view should extend from the region of the clavicle inferiorly to the inframammary fold and laterally to include the axilla
• Obtaining proper homogeneous fat suppression is critical for cancer detection on specific pulse sequences including but not limited to post contrast T1-weighted images
• To assess the integrity of silicone breast implants with non-contrast breast MRI images, fat suppression is critical for both the water selective and silicone selective sequences to accurately assess for peri-implant fluid and extracapsular rupture, respectively. In addition, standard T2-weighted imaging should be obtained to assess for intracapsular rupture
• To assess the morphology of a breast lesion, high-spatial resolution post-contrast fat-suppressed T1-weighted images are essential. This includes a slice thickness of 2.5 mm or less with an in-plane isotropic pixel resolution of 1 mm x 1 mm or less to reduce the effects of volume averaging and allow for reconstruction in any of the three planes
• To improve lesion conspicuity, additional post-contrast subtraction images may be used to improve the image quality but must be done with the understanding of misregistration due to patient motion
• Motion correction software may be used to reduce artifacts with Computer-Aided Evaluation (CAE)

There are various techniques that are common practice in the radiology setting* that can be implemented to minimize the presence of metal-related artifacts on MR images, such as the following:^2,7,8

• Perform MRI exam at a lower static magnetic field
• Select a different pulse sequence (e.g., FSE vs. SE; SE vs. GRE)
• Decrease the echo time
• Decrease the repetition time
• Decrease the slice thickness
• Increase the receiver bandwidth
• Increase the matrix size
• Increase the number of excitations
• Swap the phase and frequency
• Use inversion recovery for fat suppression instead of frequency selective fat suppression
• If available, use advanced software for artifact reduction (Metal artifact reduction sequencing, MARS)
• Use T2 acquisition images acquired with Turbo Spin Echo (TSE) to assess rupture
• When possible, utilize inversion recovery sequences (STIR) for fat suppression

*Accredited mammography centres and technicians with experience in examining patients with breast implants are needed to adequately visualize breast tissue in an implanted breast when going for screening of breast implants.

There are other imaging modalities 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:^2,4-7

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

Yes, due to the artifacts generated on the MR images, the patients who are classified as high-risk may need to undergo additional methods such as ultrasound or mammography. These patients can be divided into three different risk categories.⁷

I. Patients that are deemed high-risk for breast pathology (such as cancer) and have a clinical indication for contrast-enhanced breast MRI may include, but are not limited to, the following:

• Patients that have a lifetime risk of 20% or greater to develop breast cancer (e.g.: patients with genetic predisposition or those with a history of mantle radiation for Hodgkin lymphoma)
• Patients who are BRCA mutation carriers and those untested with a first-degree relative of a BRCA carrier
• Patients who are African American
• Women with dense breasts without a previous or active breast cancer diagnosis
• Patients who had upper abdominal radiation therapy which exposed the breast tissue at a young age
• Patients receiving a cumulative dose 10 Gy before age 30
• Patients with genetic syndromes that predispose them to develop breast cancer. This may include such syndromes as: (A) Li-Fraumeni syndrome, (B) Cowden syndrome, or (C) Bannayan-Riley-Ruvalcaba syndrome, or a patient who has first-degree relatives with one these syndromes
• Patients with a personal history of breast cancer and dense breast tissue or patients who have been diagnosed with breast cancer below the age of 50
• Patients with free injections of silicone, paraffin, or polyacrylamide gel in whom mammographic screening may be compromised

II. Patients that are undergoing diagnostic evaluations of suspicious breast condition, or that have an active or previous diagnosis of breast cancer and have a clinical indication for contrast-enhanced breast MRI may include, but are not limited to, the following:

• Preoperative assessment for both multifocal and multicentric disease
• Patients already diagnosed with breast cancer for: (A) Characterizing and detecting ipsilateral and contralateral ductal carcinoma in situ or invasive carcinomas and (B) Monitoring tumor response to neoadjuvant therapy such as chemotherapy or hormonal therapy
• Patients with a history of breast cancer to differentiate between preexisting scar and a possible recurrence of cancer
• Patients who underwent breast-conserving surgery with positive margins and screening after breast-conserving surgery
• Patients with suspected inflammatory breast cancer
• Patients with axillary nodal metastasis with an unknown primary or occult breast lesion on mammography and/or ultrasound (Cancer of Unknown Primary Syndrome)
• Patients with nipple discharge with inconclusive findings on other imaging studies
• Patients requiring further breast lesion characterization where other diagnostic imaging examinations, including breast ultrasound, mammography, and physical examination, are inconclusive or when a biopsy of the lesion cannot, for any reason, be performed
• Patients who have undergone breast implant reconstruction after lumpectomy or mastectomy

III. Patients with non-cancer-related conditions and have a clinical indication for contrast-enhanced breast MRI may include, but are not limited to, the following:

• Assess the stability and overall integrity of silicone breast implants. This may include, but is not limited to, identification of intracapsular rupture, extracapsular rupture, gel fracture, gel bleed, or flipped breast implants.

During breast ultrasound screening, the radiologist/radiology technician may be able to visualize the Qid^® inside the breast implant due to its good echogenicity. However, it should not interfere with the exam, its results, or a consequent diagnosis.⁴

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).