Support for Surgeons
Breast Implants
GlutealArmonic®
Samples
Sizers
Qid® Reader
MotivaImagine® Ultralight LED Retractor
Insertion Sleeve
External Sizers System
Services and Help
I have a general question
What are the requirements to get Motiva® Breast 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.
Who should NOT get breast implants?
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.
What complications might occur with breast implants?
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.
How long does the recovery process take after breast augmentation surgery?
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.
Do breast implants interfere with mammography?
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.
Can I breastfeed with breast implants?
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.
How long do Motiva® Implants last?
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.
Which Motiva® Implants will give me a round look?
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.
Which Motiva® Implants will give a more natural anatomical appearance?
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.
Based on what should I choose SmoothSilk® (SilkSurface®) or VelvetSurface® for my implants? Why does it matter?
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%.
Motiva® Implants are divided into three categories: Round, Ergonomix® and Anatomical. What exactly is the difference?
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 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.
What is the difference between Mini/Demi/Full/Corse?
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.
Can you recommend a clinic/surgeon that uses Motiva® Implants in my country?
Please find a local Motiva® Implants surgeon/clinic at the following link: https://motiva.health/surgeons/sign-up-my-practice/
Are Motiva® Implants FDA approved?
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.
Where can I find more information about your products?
Information from our products is available online at www.motiva.health
What is the Qid®?
The Qid® 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.
What are the risks associated with the microtransponder?
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.
I need information about implant registration
What are the requirements to get Motiva® Implants?
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.
I have problems registering my implants, what should I do?
Please send us a support request by clicking here or the "Request Support" button at the bottom of the page.
I have problems registering my implants, what should I do?
The picture below is where the Electronic Serial Number (ESN), Serial number (SN) and online validation code (VC) are located on your Patient card.
I need information about breast screening
Why are Motiva® Implants available with RFID technology?
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.
Are There Any Safety Concerns for Patients With Motiva® Implants with Qid®?
Qid® 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. Qid® 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.
Can Qid® affect MRI evaluation for a potential implant rupture?
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. The Qid® 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 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.
What specifically causes artifacts?
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.
What Information Needs to Be Provided to the Radiologist Prior to an MRI of Motiva® Implants with Qid®?
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.
Are There Alternative or Additional Imaging Modalities That Will Improve Visualization of the Artifact-Affected Area?
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.
Other Than Improved Imaging Visualization, Are There Any Other Benefits to Adding a Second Imaging Modality?
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 Qid®.
What extended warranty programs are available for Motiva® Implants with Qid®?
If a patient registers her Motiva® Implants with Qid® 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 Qid® 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 Qid® 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 implanta 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 testsb.
a:
- €2500 / Euro Zone
- £2500 / U.K.
- $2500 / Rest of the world
b:
- €500 / Euro Zone
- £500 / U.K.
- $500 / Rest of the world
I need information about warranties
Are all Motiva Implants® are covered for the lifetime of the device?
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.
How can I extend the coverage of my Motiva Implants®?
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
Do all the Motiva Implants® qualify for the extended 2 and 5 years warranty?
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™
In what cases does the extended warranty not apply?
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.
How Should I File a Warranty Claim?
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.
I want to file a complaint
Filing a Complaint
For additional guidance on how to file a complaint please contact the local representative or Establishment Labs Customer Service Department at customerservice@establishmentlabs.com BEFORE any implant is explanted.
To file a complaint 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). You can fill out this document manually by downloading the PDF, or you can fill it out online by clicking here. 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 complaints: 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 complaints: 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).
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I have a general question
What are the requirements to get Motiva® Implants GlutealArmonic®?
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.)
What complications might occur with gluteal implants?
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.
How long do Motiva® Implants GlutealArmonic® last?
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.
What is a microtransponder?
The microtransponder is indicated for use as a miniature, implantable microtransponder that is inserted into the GlutealArmonic® implant. The microtransponder in the GlutealArmonic® implant provides the patient a unique electronic serial number that may be used to access a database containing the gluteal implant information (serial and lot numbers; reference number; volume, size and projection, model, surface type, manufacturing date, etc.)
Is the microtransponder MRI safe?
It is MRI conditional, patients with gluteal implants containing a microtransponder may safely undergo MRI diagnostics in up to 3 Tesla cylindrical systems.
Will I need to wear a compression garment after my butt augmentation?
Yes, a compression garment should be worn for a few days following your butt augmentation.
How much does the recovery period last? When can I exercise or return to strenuous activity?
The recovery period from a gluteal area enhancement surgery with gluteal implants lasts 4 - 6 weeks. You must avoid strenuous activities such as bicycling and jogging for at least 4 weeks.
I want to file a complaint
Filing a Complaint
- 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), to Other topics.
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I have a general question
How can I order some samples?
Please contact your local distributor.
Where can I find the product catalogue?
For further information, please contact your local distributor.
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I have a general question
What are the indications for the Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®?
Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term breast implant to use. Prior to using the Intraoperative, Single-use, Sterile, Silicone Breast Sizers, the physician should be familiar with all the literature associated with the Motiva Implant Matrix® implants to be used
Could this device be reused or re-sterilized?
Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® MUST NOT BE REUSED OR RESTERILIZED UNDER ANY CIRCUMSTANCE. They are intended for SINGLE USE ONLY and are designed for TEMPORARY USE AND MUST NOT BE LONG-TERM IMPLANTED. The Sizers’ boxes are specifically labeled “SINGLE-USE- DO NOT RESTERILIZE” and "NOT FOR LONG-TERM IMPLANTATION". The patch also identifies the devices as SIZER. NEVER, UNDER ANY CIRCUMSTANCE, ATTEMPT TO RESTERILIZE THIS DEVICE.
Why are the sizers tinted?
The filling gel is tinted with pigments, in order for the Sizers to be clearly differentiated from the long-term implantable devices. This visual indicator is a very important feature because the sizers are single-use, temporary devices that must never, under any circumstance, be for long-term implanted and must be discarded after being used.
What are the contraindications of the Intraoperative Sizers?
THE USE OF INTRAOPERATIVE, SINGLE-USE, STERILE, SILICONE BREAST SIZERS MOTIVA IMPLANT MATRIX® AS LONG-TERM BREAST IMPLANTS IS ABSOLUTELY CONTRAINDICATED. The use of these devices as long-term implants may result in serious endangerment to the patient´s health and safety. Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are contraindicated in the same cases where MIM® Breast Implants are contraindicated. Please refer to the Motiva Implant Matrix® Silicone Breast Implants Product Insert for information on the implants contraindications.
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I have a general question
What is the Qid® Reader?
Qid® is a revolutionary, FDA cleared, first of its kind technology that provides the patient with an electronic serial number from within their body for complete control and verification of the breast implants. This ensures extended safety and wellbeing for the patient and precise data in the unlikely event of a recall or an adverse event.
Following surgery, the patient can return to the surgeon´s to have her implant(s) verified and registered via the Motiva Qid® Handheld Reader. The 15-digit number delivered to the reader corresponds with a secure, online database that can be accessed via the internet and by the surgeon and the patient only.
How do I read the code?
The start button is located on the back of the reader. To power the unit on, simply push on the symbol located on the back panel by the words “press here” and then release.
The display screen will show Motiva Qid® Reader “Reading” and the reader will emit a single beep. If no valid Electronic Serial Number (ESN) is found within 20 seconds, then the display window will indicate “No Device Found” and the reader will again emit a single beep. If there is no activity within 40 seconds, the reader will automatically turn off.
The outer surface of the Motiva Q Inside™ Reader is the reading area. When a valid ESN is found, the reader will emit a double beep sound and the complete ESN number will be shown on the display screen.
What can I do if the Electronic Serial Number is not found?
When an ESN is located, you will hear a beep, followed by a 15-digit numeric sequence shown on the display screen. If no MT is found, try reading again moving slowly in different directions and varying the angles of the reader on the breast area. If no ESN is still found, re-test the Motiva Q Inside™ Reader with the test ESN provided.
Further operation instructions for the Motiva Qid® Reader are located in the User Manual, which can be downloaded from the flash drive included with the reader.
How should the Motiva Qid® Reader be cleaned and maintained?
The Motiva Qid® Reader reader should never be submersed in liquid or placed in any sterilization equipment. It can be easily wiped down with a Steriwipe® or by moistening a cloth with a disinfecting solution.
How is the Motiva Qid® Reader recharged?
When the battery is running low on the Motiva Qid® Reader, the following message will appear on the display screen - “Battery Low”. To recharge the battery, simply plug the USB cable into the back of the reader and into an available USB port.
A fully discharged battery will need to charge for up to three and half hours in order to be fully recharged. During the charging cycle, the display will switch off. To check if the battery has finished charging, simply press the start button and the display screen will inform you if it is still “Charging” or “Charged”.
What are the technical specifications of the Motiva Qid® Reader
- The device is ROHS compliant and meets ISO 11784 and 11785
- Dimensions are 135mm diameter x 33mm (5.315 inches diameter x 1.299 inches deep)
- Weight is 70g (2.4962 ounces)
- Reads per charge are 8 second scans x 1000. The battery capacity can vary in time with normal use
- Charge time is 3.5 Hours
- Operating temperature is 0°C to +50°C (32° F to +122° F)
- Software - Windows 98 or later
- Warranty - 1 Year manufacturer’s warranty against defects in materials or workmanship that prevent its use
- Atraumatic handling minimizes tissue damage and increases graft viability.
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I have a general question
What is the indicated use of MotivaImagine® Ultralight LED Retractor?
The MotivaImagine® Ultralight LED Retractor is a single-use cordless retractor with an integrated LED light source. It is indicated for use in retracting soft tissue to enhance exposure during surgical procedures.
The MotivaImagine® retractor was designed for use in breast augmentation procedures – in particular, Motiva MinimalScar®, which involves the use of innovative, minimally invasive tools and techniques to reduce incision length down to nearly half its standard size.
Is the MotivaImagine® Ultralight LED Retractor FDA cleared and CE certified?
It is FDA cleared and CE certified.
What makes the MotivaImagine® retractor different from other retractors on the market?
The MotivaImagine® Bulb-Cannula Kit includes:
- The MotivaImagine® retractor, which is 20 mm wide, is narrower than a standard retractor to provide better visualization via smaller incisions (such as those made during Motiva MinimalScar™ breast augmentation procedures)
- As it is made of plastic, it weighs less than other retractors, making it easier to handle during surgery
- One bulb injector
- It has an integrated LED light source to allow for better visualization of the surgical area
The MotivaImagine® retractor also possesses depth marks/measuring guidelines in 10 mm increments for precise pocket measurement.
Can this device be sterilized or reused?
The MotivaImagine® retractor is not compatible with gamma radiation or autoclave sterilization and should never be sterilized by any method. Never reuse this device, as its strength may be significantly compromised after initial use and the resulting risk to the patient and/or user is unknown.
Contact us if you would like further information about the MotivaImagine® retractor, and to find out who distributes it in your country.
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What is an insertion sleeve?
The MotivaImagine® Insertion Sleeve is a sterile, transparent, cone shaped sleeve constructed of a flexible, polymeric film and has a lubricious hydrophilic coating on the inside surface, intended to to assist with the delivery of silicone gel implants by providing a shell-tissue interface with less friction during insertion of the implant.
Could this device be reused or resterilized
This product is intended for single use, one patient only. Each MotivaImagine® Insertion Sleeve is sterilized by ethylene oxide in a sealed, double-pouched configuration. Sterility is maintained only if the package seals are intact. Do not re-sterilize the sleeve. Re-use or re-sterilization should not be performed under any conditions as contamination or infection may occur. Attempts to re-use or re-sterilize may cause diminished product performance, including loss of lubricity, potentially causing implant damage, including rupture.
Questions about Product Warranty?
Establishment Labs stands behind the MotivaImagine™ Insertion Sleeve (EL-001). If you experience any difficulties attributable to the materials or manufacturing defects, we will replace the product. Please place your claim by clicking here.
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I have a general question
How can I order external sizers
Please contact your local distributor.
Where can I find the product catalogue?
For further information, please contact your local distributor.