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Submitted URL: http://mentordirect.com/
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Submission: On September 26 via api from US — Scanned from CA

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                      <div class="slide_text" style="width:225px;"> From the worldwide leader<br> in breast aesthetics<sup style="top:0.1em;font-size:8px;">1</sup>, a shaped <br>implant with
                        <i style="color:#333;">proven projection <br>performance and peace of mind</i>. <div style="font-size:10px;padding-top:51px;font-weight:normal;">1 Data on file at Mentor Worldwide LLC.</div>
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                      <div class="slide_text"> EXPANSION REIMAGINED. <div style="padding-top:5px;"></div> Engineering Precise Pocket Control. </div>
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                      <div style="position: absolute; top: 95px; left: 40px; width: 320px; height: 65px; color:#074a8d; font-size:32px;">MemoryGel<sup>®</sup> Xtra Breast Implants</div>
                      <div class="slide_text" style="width:335px;"> The soft, natural feel your patients desire with the increased projection, fullness and firmness. <sup style="top:0.1em;font-size:8px;">1</sup>
                        <div style="font-size:10px;padding-top:51px;font-weight:normal;">1 In-person consumer survey with 45% respondents.</div>
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                      <div style="font-size:10px;padding-top:51px;font-weight:normal;position: absolute; top: 225px; left: 440px; width: 220px;">© Mentor Worldwide LLC 2017 049328-170921</div>
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                                        MemoryGel<sup>®</sup> Breast&nbsp;Implants
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										MENTOR<sup>®</sup> MemoryShape<sup>®</sup> Breast Implants
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                                        MENTOR<sup>®</sup> ARTOURA<sup>™</sup> Breast Tissue Expander
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      <div class="FDA-footer-warning__header"> WARNING: </div>
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          <p> Breast implants are not considered lifetime devices. The longer people have them, the greater the chances are that they will develop complications, some of which will require more surgery. </p>
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          <p> Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This cancer occurs more commonly in patients with textured breast
            implants than smooth Implants, although rates are not well defined. Some patients have died from BIA-ALCL. </p>
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          <p> Patients receiving breast implants have reported a variety of systematic symptoms such as joint pain, muscle aches, confusion chronic fatigue, autoimmune diseases and others. Individual patient risk for developing these symptoms has not
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      <p> Caution: US law restricts this device to sale by or on the order of a physician. </p>
      <p> The sale and distribution of Mentor Breast Implant Devices are restricted to users and/or user facilities that provide information to patients about the risks and benefits of the device prior to its use in the form and manner specified in
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  <div class="footer-copyright"> © Mentor Worldwide LLC 2024 049328-160315, 049328-170419, 084025-171211. All Rights Reserved.<br> This site is published by Mentor Worldwide LLC which is solely responsible for its contents.<br> This site is intended
    for Healthcare Professionals in the United States.<br> * Pages display best on Internet Explorer 8 and above * <div style="height: 10px;"></div>
    <p>MENTOR<sup>®</sup> MemoryGel<sup>®</sup> Breast Implants, MENTOR<sup>®</sup> MemoryShape<sup>®</sup> Breast Implants, and MENTOR<sup>®</sup> Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old
      for MemoryGel<sup>®</sup> Implants and MemoryShape<sup>®</sup> Implants, and 18 years old for Saline Implants) or for breast reconstruction. Breast implant surgery should not be performed in women with active infection anywhere in their body,
      with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions, or who are currently pregnant or nursing.</p>
    <p>Breast implants are not lifetime devices and breast implantation may not be a one-time surgery. The most common complications for breast augmentation and reconstruction with MemoryGel<sup>®</sup> Implants include any reoperation, capsular
      contracture, and implant removal with or without replacement. The most common complications with MemoryShape<sup>®</sup> Implants for breast augmentation include reoperation for any reason, implant removal with or without replacement, and
      ptosis. The most common complications with MemoryShape<sup>®</sup> Implants for breast reconstruction include reoperation for any reason, implant removal with or without replacement, and capsular contracture. A lower risk of complication is
      rupture. The health consequences of a ruptured silicone gel breast implant have not been fully established. MRI screenings are recommended three years after initial implant surgery and then every two years after to detect silent rupture. The
      most common complications with MENTOR<sup>®</sup> Saline-filled Implants include reoperation, implant removal, capsular contracture, breast pain, and implant deflation. </p>
    <p>For MemoryGel<sup>®</sup> Implants, patients should receive a copy of Important Information for Augmentation Patients about MENTOR<sup>®</sup> MemoryGel<sup>®</sup> Breast Implants or Important Information for Reconstruction Patients about
      MENTOR<sup>®</sup> MemoryGel<sup>®</sup> Breast Implants. For MemoryShape<sup>®</sup> Implants, patients should receive a copy of Patient Educational Brochure – Breast Augmentation with MENTOR® MemoryShape<sup>®</sup> Breast Implants or Patient
      Educational Brochure – Breast Reconstruction with MENTOR<sup>®</sup> MemoryShape<sup>®</sup> Breast Implants, and a copy of Quick Facts about Breast Augmentation &amp; Reconstruction with MENTOR<sup>®</sup> MemoryShape<sup>®</sup> Breast
      Implants. For MENTOR<sup>®</sup> Saline-filled Implants, patients should receive a copy of Saline-Filled Breast Implants: Making an Informed Decision. Your patient needs to read and understand the information regarding the risks and benefits of
      breast implants, with an opportunity to consult with you prior to deciding on surgery. </p>
    <p>The ARTOURA<sup>™</sup> Breast Tissue Expander or CONTOUR PROFILE<sup>®</sup> Breast Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect
      procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. Do not use the ARTOURA<sup>™</sup> Tissue Expander nor CONTOUR PROFILE<sup>®</sup> Tissue Expander in
      patients where an MRI may be needed. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. The incidence of extrusion of the expander has been shown to increase when the expander has
      been placed in injured areas.</p>
    <p>For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR<sup>®</sup> Implantable Devices, which include MENTOR<sup>®</sup> Saline-filled Implants, MemoryGel<sup>®</sup> Implants,
      MemoryShape<sup>®</sup> Implants, ARTOURA<sup>™</sup> Expanders, and CONTOUR PROFILE<sup>®</sup> Expanders, please refer to the Product Insert Data Sheet provided with each product or visit www.mentorwwllc.com.</p>
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From the worldwide leader
in breast aesthetics1, a shaped
implant with proven projection
performance and peace of mind.
1 Data on file at Mentor Worldwide LLC.
EXPANSION REIMAGINED.

Engineering Precise Pocket Control.
MemoryGel® Xtra Breast Implants
The soft, natural feel your patients desire with the increased projection,
fullness and firmness. 1
1 In-person consumer survey with 45% respondents.
© Mentor Worldwide LLC 2017 049328-170921
MemoryGel® Breast Implants
MENTOR® MemoryShape® Breast Implants
MENTOR® ARTOURA™ Breast Tissue Expander
 * 1
 * 2
 * 3
 * 4



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WARNING:

 * Breast implants are not considered lifetime devices. The longer people have
   them, the greater the chances are that they will develop complications, some
   of which will require more surgery.

 * Breast implants have been associated with the development of a cancer of the
   immune system called breast implant-associated anaplastic large cell lymphoma
   (BIA-ALCL). This cancer occurs more commonly in patients with textured breast
   implants than smooth Implants, although rates are not well defined. Some
   patients have died from BIA-ALCL.

 * Patients receiving breast implants have reported a variety of systematic
   symptoms such as joint pain, muscle aches, confusion chronic fatigue,
   autoimmune diseases and others. Individual patient risk for developing these
   symptoms has not been well established. Some patients report complete
   resolution of symptoms when the implants are removed without replacement.

Caution: US law restricts this device to sale by or on the order of a physician.

The sale and distribution of Mentor Breast Implant Devices are restricted to
users and/or user facilities that provide information to patients about the
risks and benefits of the device prior to its use in the form and manner
specified in approved labeling to be provided by Mentor Worldwide LLC.

© Mentor Worldwide LLC 2024 049328-160315, 049328-170419, 084025-171211. All
Rights Reserved.
This site is published by Mentor Worldwide LLC which is solely responsible for
its contents.
This site is intended for Healthcare Professionals in the United States.
* Pages display best on Internet Explorer 8 and above *


MENTOR® MemoryGel® Breast Implants, MENTOR® MemoryShape® Breast Implants, and
MENTOR® Saline-filled Breast Implants are indicated for breast augmentation in
women (at least 22 years old for MemoryGel® Implants and MemoryShape® Implants,
and 18 years old for Saline Implants) or for breast reconstruction. Breast
implant surgery should not be performed in women with active infection anywhere
in their body, with existing cancer or pre-cancer of their breast who have not
received adequate treatment for those conditions, or who are currently pregnant
or nursing.

Breast implants are not lifetime devices and breast implantation may not be a
one-time surgery. The most common complications for breast augmentation and
reconstruction with MemoryGel® Implants include any reoperation, capsular
contracture, and implant removal with or without replacement. The most common
complications with MemoryShape® Implants for breast augmentation include
reoperation for any reason, implant removal with or without replacement, and
ptosis. The most common complications with MemoryShape® Implants for breast
reconstruction include reoperation for any reason, implant removal with or
without replacement, and capsular contracture. A lower risk of complication is
rupture. The health consequences of a ruptured silicone gel breast implant have
not been fully established. MRI screenings are recommended three years after
initial implant surgery and then every two years after to detect silent rupture.
The most common complications with MENTOR® Saline-filled Implants include
reoperation, implant removal, capsular contracture, breast pain, and implant
deflation.

For MemoryGel® Implants, patients should receive a copy of Important Information
for Augmentation Patients about MENTOR® MemoryGel® Breast Implants or Important
Information for Reconstruction Patients about MENTOR® MemoryGel® Breast
Implants. For MemoryShape® Implants, patients should receive a copy of Patient
Educational Brochure – Breast Augmentation with MENTOR® MemoryShape® Breast
Implants or Patient Educational Brochure – Breast Reconstruction with MENTOR®
MemoryShape® Breast Implants, and a copy of Quick Facts about Breast
Augmentation & Reconstruction with MENTOR® MemoryShape® Breast Implants. For
MENTOR® Saline-filled Implants, patients should receive a copy of Saline-Filled
Breast Implants: Making an Informed Decision. Your patient needs to read and
understand the information regarding the risks and benefits of breast implants,
with an opportunity to consult with you prior to deciding on surgery.

The ARTOURA™ Breast Tissue Expander or CONTOUR PROFILE® Breast Tissue Expander
can be utilized for breast reconstruction after mastectomy, correction of an
underdeveloped breast, scar revision, and tissue defect procedures. The expander
is intended for temporary subcutaneous or submuscular implantation and is not
intended for use beyond six months. Do not use the ARTOURA™ Tissue Expander nor
CONTOUR PROFILE® Tissue Expander in patients where an MRI may be needed. The
device could be moved by the MRI causing pain or displacement, potentially
resulting in a revision surgery. The incidence of extrusion of the expander has
been shown to increase when the expander has been placed in injured areas.

For detailed indications, contraindications, warnings, and precautions
associated with the use of all MENTOR® Implantable Devices, which include
MENTOR® Saline-filled Implants, MemoryGel® Implants, MemoryShape® Implants,
ARTOURA™ Expanders, and CONTOUR PROFILE® Expanders, please refer to the Product
Insert Data Sheet provided with each product or visit www.mentorwwllc.com.

 
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