Support for Surgeons

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.

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 your profile and other variables. During the first 48 hours, 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. Always follow your surgeon advice for the post-operatory period.

You should inform your examiners about the presence, type, and placement of your implants, and to 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 adequately visualize breast tissue in the implanted breast. 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.

Breast implant surgery may interfere with the ability to successfully breastfeed, either by reducing or eliminating milk production. Although 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. At this time, it is not known if it is possible for a small amount of silicone to pass from the breast implant silicone shell into breast milk during breastfeeding, or what the potential consequences might be. A periareolar surgical approach may further increase the chance of breastfeeding difficulties. However, the American Academy of Pediatrics has stated that there is no reason why a woman with implants should refrain from nursing.

Breast Implants are not lifetime devices. However, the life expectancy of a silicone breast 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. If you experience pain or a change in appearance please see your doctor. For safety, as well as the most beautiful and healthy outcome, it is important that you return to your plastic surgeon’s office for the follow-up evaluations prescribed by your doctor. Yearly visits are recommended to verify the device integrity. During the 10-year follow-up visit the surgeon should assess whether or not it is advisable to remove and replace the implants.

Motiva Implants® Round with ProgressiveGel™ PLUS, provides the highest projection and a complete filling of the upper pole. For the type of results mentioned, the recommended implants should be these. However, the desired results for each patient should be evaluated individually by the surgeon.

Motiva Implants® Ergonomix® with ProgressiveGel ULTIMA, were designed for women who want a breast implant that offers the most natural look and feel possible; one that adapts to their natural movements and gives them confidence in their normal lifestyle situations. For the type of results mentioned, the recommended implants should be these. However, the desired results for each patient should be evaluated individually by the surgeon.

Motiva Implants® surfaces try to mimic the cellular dimensions, enhancing the biocompatibility of the implants resulting in less abrasion and a controlled inflammatory response after breast augmentation, even in patients with active lifestyles, features that can decrease complications after breast augmentation. Choosing one surface against the other would depend on the surgeon preferences. The most used is SmoothSilk® (SilkSurface®) which has the smaller surface dimensions. Other surgeons prefer VelvetSurface® because it has a higher roughness. Both Motiva Implants® surfaces have low complications rates of less than 1%.

Round implants provide a higher top and a more full-bodied appearance. They are the most common implants and are used in almost 80 percent of all breast augmentation surgeries.
Anatomical implants are often called tear-drop-shaped, because they are designed to simulate the shape of a natural breast. While the result with an anatomical implant is natural looking, the predefined shape means the implant lacks natural movement and doesn’t shift with the body’s movements. As an example, see how noticeable the lack of movement is when this patient goes from lying down to standing up. The implant retains the same shape whether the patient is prone or upright.
Motiva’s Ergonomix® implants avoid this drawback using a unique gel which is very soft, allowing the implant to follow a women’s natural movement, holding a round shape when lying down and assuming a teardrop shape when standing. This gives a very natural appearance, both in look and feel.

The main difference is the projection size. This means that our MINI has the smallest projection, then our DEMI, following our FULL size and the biggest projection will be our CORSE. To select the perfect size, you should contact your surgeon who is going to select the implant projection depending on your torso and chest size,s as well as your final desired results.

Please find a local Motiva Implants® surgeon/clinic at the following link: https://www.motiva.health/center-locator/

No. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA to initiate the Motiva Implant® clinical trial in the United States. Motiva Implants^® are CE mark approved.

Information from our products is available online at www.motiva.health

The Q Inside® Safety Technology is the world’s first FDA approved transponder for use in humans. It was FDA cleared in 2004 and the only one with CE-Mark for use in a breast implant. It consists of a biocompatible RFID (passive radio-frequency identification) microtransponder which provides an electronic serial number that is accessed by an owned handheld reader (Motiva Q Inside® Reader Standard) when waved over the breast area for traceability post-implantation. Motiva Implants® are available with and without a microtransponder. The microtransponder is a device which is placed in the breast implant filler material. It has been separately reviewed and cleared for marketing by the FDA for use as an implantable microchip that is inserted into the subcutaneous tissue of a patient to provide an electronic serial number that may be used to access a database containing the patient’s identity and health information.

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.

How can I register my Motiva Implants®?

1. Open the MotivaImagine App and go to “Register your Implants” or open the MotivaImagine® website and sign up with either Facebook, Google or 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).
• Option B: Electronic Serial Number (ESN).

8. Click “Submit” to the registration of your implant(s).

9. You will receive a confirmation e-mail indicating that your implant(s) have been succesfully registered.

Please send us a support request by clicking here or the "Request Support" button at the bottom of the page.

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

Motiva Implants® are available with a radio-frequency identification (RFID) microtransponder embedded in the silicone gel known as the Q Inside® Safety Techonology. 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.

Q Inside® Safety Technology does not pose any safety concerns for patients. It has been proven to be both safe & effective because it tolerates all conditions to which it will be exposed. 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 per ISO Standard 14630: ”Non-active Surgical Implants”, meaning that it is a device that showed 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 in Motiva Implants® with Q Inside® Safety Technology, MRI should be the first imaging of choice. The Q Inside® Safety Technology is a small and light device comprising 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 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 obscures some breast tissue as well and may cause complications in obtaining a 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.

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.

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.

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 actually improve cancer detection accuracy. with or without the presence of Motiva Implants® with Q Inside® Safety Technology.

If a patient registers her Motiva Implants ^® with Q Inside^® Safety Technology within the first 90 days after implantation she will receive 1 free year extended warranty that entitles the patient for financial aid in case of rupture or capsular contracture Baker grades III or IV, which is subject to terms, conditions and procedures.

5Y Motiva Program^™ : A 5 year extended warranty program is also available for Motiva Implants^® with Q Inside^® Safety Technology registered in the Motiva website or Motiva app, only when a non-refundable fee of $200 has been paid to enroll the patient in the program. Patients must also register their Motiva Implants^® with Q Inside^® Safety Technology during the first 90 days after the initial breast surgery. Patients enrolled in the 5Y Motiva Program ^™, in addition to the replacement product, may also receive financial assistance for each affected implant^a applicable to the cost of the revision surgery in the case of a warranty claim for rupture or capsular contracture Baker grades III or IV, when complying to this terms, conditions and claim procedures. I also includes financial assistance for imaging tests^b.

a:

• €2500 / Euro Zone
• £2500 / U.K.
• $2500 / Rest of the world

b:

• €500 / Euro Zone
• £500 / U.K.
• $500 / Rest of the world

All Motiva Implants® silicone breast implants are covered by the Always Confident Warranty® against rupture for the lifetime of the device and by our Product Replacement Policy in the event of capsular contracture Baker grades III and IV for a period of 10 years. To learn more about our Warranty Program Terms and Conditions click here.

To extend the coverage of your Motiva Implants® silicome breast implants; 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 Implants® silicone breast implants through our website or through the Motiva App within the first 90 days after the initial breast surgery. Patients with Qualified Q inside 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 implanta 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 SilkSurface® Plus without Q inside and Ergonomix® implants without Q inside registered in the Motiva website and Motiva app when a non-refundable feed 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 implantb 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 to the terms, conditions and claim procedures available in Motiva Site and App.
• 5Y Extended Warranty Program. The Motiva 5 year Extended Warranty Program applies only to the qualified SilkSurface® Plus with Q inside and Ergonomix® implants with Q inside registered in the Motiva website and Motiva app when a non-refundable feec 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 Q Inside® Safety Technology, with our 5Y Motiva Program™, in addition to the replacement product customer may also receive financial assistance per impacted implant a 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 to the terms, conditions and claim procedures available in the Motiva Site and App.

a.

€2500 / Euro Zone
£2500 / U.K.
$2500 / Rest of the world
b.

€1000 / Euro Zone
£1000 / U.K.
$1000 / Rest of the world
c.

€200 / Euro Zone
£200 / U.K.
$200 / Rest of the world
d.

€100 / Euro Zone
£100 / U.K.
$100 / Rest of the world

Qualified Motiva breast implant for the 2Y Extended Warranty are as follows:

• Round, SilkSurface® Plus™ without Qid™
• Round, VelvetSurface Plus without Qid™
• Round, Ergonomix without Qid™

Qualified Motiva breast implant for Free First Year and 5Y Extended Warranty are as follows

• Round, SilkSurface® Plus™ with Qid™
• Round, VelvetSurface Plus with Qid™
• Round, Ergonomix with Qid™

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 licensed surgeons. Motiva Implants® standard and extended warranty program do not apply to:

• Removal of intact implants for capsular contracture, Baker Grade I or Baker Grade 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.

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

To file a claim for any of our Warranty Programs or our Product Replacement Policy, Click here For all claim filing you must be accompanied by your surgeon.

Please contact the local representative or Establishment Labs Customer Service Department at customerservice@establishmentlabs.com for guidance on providing the necessary information and support documentation BEFORE any implant is explanted.

For additional guidance on how to file a claim please contact the local representative or Establishment Labs Customer Service Department at customerservice@establishmentlabs.com BEFORE any implant is explanted.

To file a claim for any warranty program patient must accompanied by their surgeon and submit the required documentation as follows:

The following information is required to verify eligibility for financial assistance and/or product replacement under the Extended Warranty Program

• Information to document the patient’s implant information and the patient’s event description FOR-302 Complaint Notification (Customer) / FOR.S-302 Notificación de quejas (Cliente). This document must be completed and signed by the treating surgeon. This report includes vital information that must be accurately stated, such as the device reference, series and lot numbers, volume, base, projection, expiration date and type. It also must contain a detailed description of the event being reported.
• A copy of the operative report for the revision surgery.
• Copies of bills showing operating room, anesthesia, and surgeon fees incurred for the replacement surgery.
• For capsular contracture Baker grades III and IV claims: an ultrasound with the correspondent technician report or an MRI scan and photographs of the patient as clinical evidence; and the doctor’s report on the case showing the appearance of the breast prior to the explant procedure.
• For rupture claims: the explanted product is required; exceptionally when local applicable laws do not allow it please contact Establishment Labs for assistance. When local applicable laws allow it the patient must require for the surgeon to send the removed and decontaminated product following the Explanted Breast Implants Handling Protocol (SID-129).