Für weitere Multimediale Inhalte, wechseln Sie bitte in den Loginbereich.

Anmelden Registrieren

ESTABLISHMENT LABS - MOTIVA BRUSTIMPLANTATE

Mit über 30 Jahren Erfahrung in der Entwicklung und Herstellung qualitativ hochwertiger Brustimplantate hat sich Establishment Labs zum Ziel gesetzt, ein Produktsortiment zu entwickeln, das in puncto Sicherheit und Design seinesgleichen sucht. Dies ist mit der Brustimplantat-Serie Motiva Implant Matrix® auf höchstem Niveau gelungen. Mit ihr finden Arzt und Patientin eine breite Produktpalette vor.

Eine sehr große Auswahl an Formen und Größen ermöglichen Ihnen als Arzt optimale ästhetische Ergebnisse.

Dabei stehen bei unseren Innovationen, wie dem ProgressiveGel Ultima™ sowie der Q Inside Safety Technology™ höchste Qualität und Sicherheit im Fokus. Alle Produkte von Establishment Labs haben ein gemeinsames Ziel: sowohl Ihnen als Arzt als auch den anspruchsvollen Patientinnen von heute ein Mehr an Sicherheit bei Brustaugmentationen zu geben.

Durch die spezielle Mikro- und Nanotexturierung heben sich die Motiva Brustimplantate deutlich von dem derzeitigen durch Zucker- oder Salzbehandlung entstehenden Texturierungsstandard ab und schaffen so eine neue und äußerst schonende Oberfläche. Dieses neue, patentierte Verfahren zeigte in Tests und Studien bereits seine hervorragende Wirkung (siehe Webinhalte im Loginbereich dieser Website).

Hier finden Sie unseren Patientenflyer:

Dokument download

 

Aktuelle Fragen bzgl. der Sicherheit der Motiva Implants®

General Questions

What are the requirements to get Motiva Implants® 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, with existing carcinoma of the breast (without mastectomy), with advanced fibrocystic disease considered premalignant (without accompanying subcutaneous mastectomy), with any disease clinically known to impact wound-healing ability, with tissue characteristics clinically incompatible with mammoplasty, with any condition – or treatment – determined by the surgeon to constitute an unjustifiable surgical risk and 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, Anaplastic Large Cell Lymphoma (ALCL) and others. Talk to your doctor about other complications.

How long does it take the recovery process 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.

Does the breast implants Interfere with Mammography?

You should inform your examiners about the presence, type, and placement of their 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 breast feed, either by reducing or eliminating milk production. Although most women with breast implants who attempt nursing have successfully breast-fed 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 breast-feeding 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® gives a more natural appearance?

Motiva Implants® Ergonomix® with ProgressiveGel ULTIMA, were designed for women who look for 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 Silk or Velvet surface for my implants? How 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. Therefore, those features decrease complications after breast augmentation. Choosing one surface against the other would depend on the surgeon preferences. The most used is SilkSurface® which has the smaller surface dimensions. Other surgeons prefer VelvetSurface® because it has a higher roughness. Both Motiva Implants® surfaces have faq-an low complications rates, less than 1%.

Motiva Implants® are divided into three categories: Round, Ergonomix and Anatomical. But 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’s Ergonomix® implants avoids 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 sizes 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: www.motivaimagine.de

Are Motiva Implants® FDA approved?

No. But we have started with the FDA clinical investigation trial to become a FDA certification. Motiva Implants® are CE mark approved.

Where can I find more information about your products?

Information from our products is available online at www.motivaimplants.com

What is the Q Inside Safety Technology?

The Q Inside Safety Technology is the world’s first FDA approved transponder for use in humans cleared in 2004 and the only one with CE-Mark when used in a breast implant, which 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 recognition post-implantation. Motiva Implants® may or may not contain a microtranspoder. The microtransponder is a device which is placed in the breast implant filler material. This microtransponder has been separately reviewed and cleared for marketing by the U.S. Food and Drug Administration for use as an implantable microchip that is inserted into the subcutaneous tissue of a patient to provide the patient 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.

Implantatsregistrierung

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.

What is the SN / ESN?

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

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 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.

Are There Any Safety Concerns for Patients With Motiva Implants® with Q Inside Safety Technology?

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.

Can Q Inside Safety Technology 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 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.

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 Q Inside Safety Technology?

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?

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 Q Inside Safety Technology.

What extended warranty programs are available for 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 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

Download Q Inside Safety Facts

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 implanta 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.

 

5-JAHRES-STUDIE

Die Ergebnisse der Ende September veröffentlichen 5-Jahres-Studie von Establishment Labs über den Einsatz verschiedenster Brustimplantate ist nun öffentlich; die Ergebnisse belegen die äußert gute Verträglichkeit und das geringe Risiko der Motiva-Implantate.

Die wohl wichtigsten Daten dieser Studie: insgesamt gab es bei 102.498 Implantaten 95 Reklamationen; 16 davon waren auf Produktfehler zurückzuführen. Es ist kein einziger Fall von Doppelkapselbildung, späteren Seromen oder ALCL aufgetreten.

Dokument download

 

MOTIVA OBERFLÄCHEN

Die Oberflächen der Motiva Implantate werden komplett ohne Zucker oder Salz hergestellt. Dies bewirkt zum einen eine wesentlich sanftere und einheitlichere Struktur als auch eine wesentlich bessere Verträglichkeit der Implantate. Aktuelle Studien zeigen einen Zusammenhang zwischen aggressiver Texturierung mit Zucker oder Salz und späteren Komplikationen wie zum Beispiel ALCL.

  • Sichere Hüllenoberfläche ohne aggressive Vertiefungen. Keine Reste von Salz- oder Zuckerkörnern.
  • Optimierte, einheitliche Hüllenoberfläche
  • Einheitliche Implantatshülle ohne die traditionellen “dünnen Stellen”
  • SilkSurface™ – NanoSurface™ – 8.000 Kontaktpunkte mit einer Tiefe von 16 Mikron pro cm²
  • VelvetSurface™ – MicroSurface™ – 1.800 – 2.200 Kontaktpunkte mit einer Tiefe von 40-100 Mikron pro cm²

Die Motiva Implant Matrix® Oberflächen werden in einem einzigen, schonenden Schritt erzeugt. Eine kontrollierte Oberflächenbehandlung wird durch den Motiva 3D Inversion™ Herstellungsprozess erreicht, wobei kein Fremdmaterial hinzugefügt wird. Dies führt zu folgenden Ergebnissen:

SilkSurface™ NanoSurface™

8000 Kontaktpunkte mit einer Tiefe von 16 Mikron pro cm²

VelvetSurface™ MicroSurface™

1800-2200 Kontaktpunkte mit einer Tiefe von 40-100 Mikron pro cm²

Eigenschaften & klinische Vorteile

  • Sichere Hüllenoberfläche ohne aggressive, durch kristalline Texturbehandlungen erzeugte Vertiefungen.
  • Keine Reste von Salz- oder Zuckerkörnern.
  • Optimierte, einheitliche Hüllenoberfläche, dadurch verbesserte Implantatseinführung, bessere Gewebefixierung und ein geringeres Risiko einer Implantatsrotation.
  • Einheitliche Implantatshülle ohne die traditionellen “dünnen Stellen”, die das Implantat weniger stabil machen, seine Haltbarkeit einschränken und die Trennschicht verschlechtern.
  • Kontrollierte Oberfläche, die ein Einführen des Implantats durch einen sehr kleinen Einschnitt ermöglicht und die das Risiko einer Doppelkapsel und eines Spätseroms vermindert.

Der Bedarf an Innovationen in der Brustimplantat-Industrie ist größer denn je: Wir begegnen dieser Nachfrage mit unserem an die Bedürfnisse der Patientin ausgerichteten Implantat-Konzept. Für Chirurgen bieten unsere Innovationen nie dagewesene Möglichkeiten, um noch sicherer arbeiten zu können.
- Salvador Dada-Santos, Production and Operations Manager

 

ELEKTRONISCHE SERIENNUMMER

  • Auslesen der Daten aus maximal 30 cm Entfernung
  • Optimale Nachverfolgbarkeit des Implantates
  • Spezifische Daten der Implantate direkt abrufbar in diesen gespeichert

Die Q Inside Safety Technology™ von VeriTeQ beinhaltet den ersten elektronischen Ausweis zur passiven Funkerkennung und Identifikation von Brustimplantaten (RFID - radio frequency identifcation). Es ist der erste für Menschen verwendete und von der FDA genehmigte elektronische Ausweis der Welt. Er ist auch der einzige, der in einem Brustimplantat mit einer CE-Kennzeichnung Verwendung findet. Die Q Inside Safety Technology™ bietet medizinischem Personal am Behandlungsort sichere und genaue Daten über das entsprechende Brustimplantat. Die Q Inside Safety Technology™ besteht aus einem biokompatiblen, mit einer unverwechselbaren, 15-stelligen Zahlenreihe versehenen elektronischem Ausweis, der ausschließlich mithilfe eines firmeneigenen Handlesegeräts direkt über der Haut ausgelesen werden kann. Die 15-stellige Zahl kann mittels einer Datenbank verifiziert werden. Die vom Patienten autorisierte Person erhält hier relevante Daten zum eingesetzten Implantat und dem Eingriff.

Durch die Q Inside Safety Technology™ haben Ärzte und Patientinnen nicht-invasiv die Möglichkeit, Daten über das Implantat zu erhalten. Anders als bei Produkt- und Garantiekarten, die eine Patientin bei einer Brustver-größerung oder -rekonstruktion normalerweise erhält, ist bei der Q Inside Safety Technology™ ein Verlieren oder Verlegen des Behandlungspasses ausgeschlossen. Brustimplantate, die mit der Q Inside Safety Technology™ ausgestattet sind, können im Falle eines Sicherheitsproblems oder einer Rückrufaktion ganz einfach nachverfolgt und kontrolliert werden. Damit geben Sie Ihren Patientinnen ein maximales Plus an Sicherheit, Transparenz und Wohlergehen.

Die Q Inside Safety Technology™ ist eine von der FDA zugelassene Technologie, die eine elektronische Seriennummer im Körper der Patientin zur Verfügung stellt und Kontrolle und Verifizierung des Implantates nicht-invasiv ermöglicht. Dies schenkt Sicherheit und Wohlbefinden auch im Falle eines Rückrufes oder eines widrigen Ereignisses.
-Scott Silverman, CEO VeriteQ Corporation

 

BLUSEAL®

SICHTBARE SPERRSCHICHTANZEIGE

  • Minimierung von Geldiffusion
  • Verminderung des Risikos einer Kapselkontraktur
  • Übertreffen der ISO und ASTM Richtlinien um ein Vielfaches

Volle Sicherheit durch unsere sichtbare Sperrschichtanzeige.

Unsere einzigartige und patentierte Barrieretechnologie BluSeal® ist eine Sicherheitseigenschaft, die nur Motiva Implant Matrix® Implantate aufweisen. Die zusätzliche Barriereschicht minimiert die Diffusion von Silikon in den Körper (eine Eigenschaft, die in der Branche seit über 20 Jahren Standard ist), indem sie das Austreten des Gels auf ein Minimum reduziert; somit wird bei allen Motiva-Implantaten das Risiko einer Kapselkontraktur erheblich vermindert.

Chirurgen können mit der BluSeal®-Barriereschicht die wichtige Sicherheitseigenschaft um das gesamte Implantat herum selbst überprüfen und 100% sicher sein, dass diese Eigenschaft in jedem Motiva Implant Matrix® Produkt vorhanden ist. Die BluSeal®-Barriereschicht erfüllt dabei die strengsten Qualitäts- und Sicherheitsstandards der American Society of Testing and Materials und der ISO.

 

TRUEMONOBLOC®

HOCHLEISTUNGSHÜLLE

  • Verbindung der Einzelteile des Implantates mit der gleichen Zugkraft
  • Verbesserung der mechanischen Eigenschaften
  • Erleichtertes Einführen des Implantates

Unsere TrueMonobloc® Technologie verbindet alle Einzelteile des Implantats mit der gleichen Zugkraft. Dadurch kann die Hülle als ganze Struktur dienen, was das Einführen erleichtert und die mechanischen Eigenschaften des Implantats unter Spannung verbessert.

Die mechanischen Testergebnisse der Motiva Implant Matrix® übertreffen die Spezifikationen der ASTM F-703: Standardspezifikation für implantierbare Brustprothesen (Sektion 9.2), die von der FDA und von ISO 14607:2009 (Sektion 7.0) vorgeschrieben sind.

 

GARANTIEPROGRAMME

» Übersicht Garantieprogramme

Eine kurze Übersicht beider Programme, die nachfolgend genauer beschrieben werden:

Dokument download

» 2Y Motiva Program

Das 2y Motiva Program stellt eine Zusatzgarantie für alle Implantate ohne QID-Technologie dar.

Dokument download

» 5Y Motiva Program

Das 5y Motiva Program stellt eine Zusatzgarantie für alle Implantate mit QID-Technologie dar.

Dokument download

 

TRUETISSUE TECHNOLOGY™ – ERGONOMIX™

  • Formannahme erst nach der Implantation
  • Keine Rotation und keine Implantatsverhärtung
  • Höchste Projektion im unteren Bereich

Unsere Motiva Ergonomix™ Implantate haben wir auf Basis der Wünsche von Patienten und Ärzten entwickelt. Plastische Chirurgen bemängeln schon lange das Problem von Rotationen bei anatomisch geformten Implantaten. Patientinnen klagen über ein unnatürliches Gefühl und Verhalten nach der Operation. Unser Designteam nahm die Herausforderung an, die herkömmlichen anatomischen Implantate zu überdenken, wobei sie die neuesten verfügbaren Verfahrensweisen anwendeten. Die Antwort kam dann von der erfahrenen Führungsspitze von Ergonomix:

Motiva Ergonomix™ Implantate sind zu 100% gefüllte Implantate, die ihre Form erst nach der Implantation anpassen, und das Aussehen eines traditionellen, „anatomischen“ Implantates annehmen. Jedoch verursachen sie nicht die klassischen Probleme der Rotation und Implantatsverhärtung. Die TrueTissue Technology™ ist die Verbindung einer klassischen elastischen Elastomer-Hülle und den speziellen rheologischen Eigenschaften des ProgressiveGel Ultima™, die in Verbindung mit der Schwerkraft den höchsten Punkt der Projektion in den unteren Bereich bringt, wenn sich die Patientin in stehender Position befindet. Wenn die Patientin flach auf dem Rücken liegt, wird sich das Implantat genau wie eine natürliche Brust verhalten und die höchste Projektion wandert zur Mitte der Brust. Motiva Ergonomix™ Implantate passen sich mithilfe der Schwerkraft der Position der Patientin an und erzielen so ein sehr natürliches Resultat.

Wieso Ergonomix™?

Wir haben die rheologischen Eigenschaften der natürlichen Brust studiert, um das hochelastische ProgressiveGel Ultima™ für ein sehr weiches, natürliches Gefühl zu entwickeln. Das ProgressiveGel Ultima™ wird mit der besten Nusil-Technologie für Silikonmaterial hergestellt und verformt sich nicht während der Implantation.

TrueTissue Dynamics™ ist der neue Standard für ein natürliches Verhalten der Brustimplantate nach der Operation. Die TrueMonobloc™ Konfiguration und das ProgressiveGel Ultima™ fungieren gemeinsam, um das natürliche Verhalten der Brust nachzuahmen und den Patientinnen ein Gefühl von Selbstsicherheit im Alltag zu vermitteln.

Unser firmeneigenes SilkSurface®, mit seiner NanoSurface Technologie™, klebt nicht am umliegenden Gewebe. So erlaubt es dem Implantat, sich den natürlichen Bewegungen anzupassen und verhindert die Abnutzung, die bei Salz- oder Zuckertexturierung auftreten kann, wenn die Frau physisch sehr aktiv ist.

 

MOTIVA GELARTEN

INNOVATIVE GELFORMEN

  • Unterschiedliche Gelarten für unterschiedliche Bedürfnisse
  • Maximale Kontrolle der rheologischen Eigenschaften
  • Hochgradig kohäsiv

Optimale Viskoelastizität

Wir bei Establishment Labs haben alle Implantate in der Matrix so entwickelt, dass drei verschiedene, hochgradig kohäsive Gels zur Verfügung stehen: Unser Progressive Gel, Progressive Gel PLUS™ und Progressive Gel Ultima™ kann je nach spezifischem Ziel der Augmentation und individuellem Wunsch der Patientin gewählt werden.

Eine maximale Kontrolle der rheologischen Eigenschaften unserer Silikongele, ihre Viskosität und Elastizität ist zu jedem Zeitpunkt sichergestellt.

Unsere Silikongele erfüllen die ASTM F 703-07 Spezifikation für implantierbare Brustprothesen - Sektion 9.2.1.4 - die von der FDA bezüglich der Gelkohäsion anerkannt ist. Wir erfüllen mit unseren Produkten Progressive Gel™, Progressive Gel PLUS™ und Progressive Gel Ultima™ weiterhin die Sektion 10.2, die als Richtlinie zur Beschreibung der Festigkeit der GelBeschaffenheit für Brustimplantate von der FDA vorgeschrieben ist.

Die Rheologie befasst sich mit der Bewegung und Deformierung von Material, auf das eine Kraft einwirkt. Zwei Extreme rheologischen Verhaltens sind:

  • Elastisches Verhalten – z. B. gänzlich steife Feststoffe – hier kehrt sich die Deformierung spontan um, wenn die Kraft nicht mehr einwirkt.
  • Viskoses (oder plastisches) Verhalten – z. B. ideal Newtonsche Flüssigkeiten – hier endet die Deformierung, wenn die Kraft nicht mehr einwirkt.

Zwischen diesen beiden Verhaltensweisen liegen die meisten reellen Substanzen; sie sind meist viskoelastisch.

 

TWINPACK™

VERBESSERTE NACHVERFOLGBARKEIT

  • Produkte sind immer gleich alt – bessere und erleichterte Verfallsdatenkontrolle
  • Gleiche Chargen bei gleichen Implantaten
  • Einfachere Zuordnung bei Rückrufaktionen

Mit dem TwinPack™ Verpackungssystem erhält die Patientin ein Paar Implantate, das garantiert zu 100% aus derselben Produktionscharge stammt. Dadurch wird sichergestellt, dass nur identische Implantate verwendet werden. Vorbei sind die Zeiten sich unterschiedlicher Implantatqualität oder verschiedener Ablaufdaten. Sowohl die Nachverfolgbarkeit der Implantate als auch die Sicherheit der Patientinnen werden so erheblich verbessert.

 

VIDEOS

Für weitere Multimediale Inhalte, wechseln Sie bitte in den Loginbereich.

Anmelden  Registrieren