4月26日，美国曼托(Mentor)公司宣布其产品MemoryGel® XTRA硅胶乳房假体获FDA认证，将于美国市场内销售，该产品能够帮助乳房重塑、隆胸或矫正手术实现更好的丰满度与突度。
Mentor® Announces FDA Approval for MemoryGel® XTRA Silicone Gel-Filled Breast Implants
IRVINE, Calif., April 26, 2017 /PRNewswire/ -- Mentor Worldwide LLC,
a global leader in breast aesthetics, today announced that it has
received approval from the U.S. Food & Drug Administration (FDA) to
market MemoryGel® Xtra silicone gel-filled breast implants in the U.S.
The new addition to the company's top-selling global brand of breast
implants offers extra fullness and projection to women undergoing breast
reconstruction, augmentation or revision surgery.
"I look
forward to being able to provide women with this new style of implant to
consider, as they evaluate the options associated with breast implant
surgery," said Dr. Louis Strock,* American Board of Plastic Surgery,
Diplomate. "MENTOR® MemoryGel® implants, with their soft, natural feel,
have been a great fit for many of my patients throughout the years. Each
enhancement to the MemoryGel product line has been thoughtfully
designed with patients in mind."
MENTOR® MemoryGel® Xtra implants will soon be available to customers in the U.S.
ARTOURA Breast Tissue Expander with a Smooth Shell
The company also announced a new addition to its ARTOURA Breast
Tissue Expander line, an expander with a smooth shell that will be
available throughout the U.S. This product widens options for
reconstructive surgeries and provides an alternative for surgeons who
may prefer a smooth expander.
The MENTOR® ARTOURA Breast
Tissue Expander is the only expander with Dynamic Control Technology
designed to provide a precise, controlled expansion. The reliable,
contoured MENTOR® ARTOURA Breast Tissue Expander simplifies expander
selection and provides a more seamless transition to final implant
selection.
"Since its launch in 2015, the MENTOR® ARTOURA
expander platform has proven to be a welcome innovation in breast tissue
expander technology," said Dr. Salvatore J. Pacella,* Division Head,
Plastic Surgery Scripps Clinic and Green Hospital in La Jolla,
California. "Having a new smooth shell configuration, in addition to the
existing SILTEX® textured shell, gives me the ability to select an
appropriately surfaced expander for my patients, which has previously
not been available. I've continued to add the smooth-shelled ARTOURA
Expander into my practice and have been very pleased with the
performance of the device, particularly with the final aesthetic result
after expander-to-implant exchange."
The ARTOURA Expander is
available in two projections and achieves a full profile at a range of
fill volumes which enables a match with corresponding MemoryShape® and
MemoryGel® Breast Implant options.
About Mentor Worldwide LLC
Mentor Worldwide LLC, part of Johnson & Johnson Medical Devices
Companies, is a leading supplier of breast implants in the global
aesthetic market. The company develops, manufactures, and markets
innovative, science-based products for surgical and non-surgical medical
procedures that allow breast surgery patients to improve their quality
of life. The company is focused on two strategic areas: breast
reconstruction and breast augmentation. MENTOR® is the only manufacturer
whose silicone breast implants are made in the U.S.A. For more
information about MENTOR® visit: www.mentorwwllc.com
Important Safety Information:
The MENTOR® Collection of Breast Implants are indicated 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 breasts who have not received adequate treatment for those conditions
Who are currently pregnant or nursing
Safety and effectiveness have not been established in patients with
autoimmune diseases (for example lupus and scleroderma), a weakened
immune system, conditions that interfere with wound healing and blood
clotting, or reduced blood supply to breast tissue. Patients with a
diagnosis of depression, or other mental health disorders, should wait
until resolution or stabilization of these conditions prior to
undergoing breast implantation surgery.
There are risks
associated with breast implant surgery. You should be aware that breast
implants are not lifetime devices and breast implantation may not be a
one-time surgery. You may need additional unplanned surgeries on your
breasts because of complications or unacceptable cosmetic outcomes. Many
of the changes to your breast following implantation are irreversible
(cannot be undone) and breast implants may affect your ability to
breastfeed, either by reducing or eliminating milk production.
Breast implants are not lifetime devices and breast implantation may not be a one-time surgery.
The most common complications for breast reconstruction with MENTOR®
MemoryGel® Breast Implants include any reoperation, implant removal
with or without replacement, and capsular contracture.
The
most common complications with MENTOR® MemoryShape® Breast 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 for breast reconstruction with MENTOR®
Saline-filled Breast Implants include reoperation, implant removal,
capsular contracture, breast pain, and implant deflation.
Detailed information regarding the risks and benefits associated with
MENTOR® Breast Implants is provided in several educational brochures.
For MemoryGel® Implants: Important Information for Reconstruction
Patients about MENTOR® MemoryGel® Breast Implants. For MemoryShape®
Implants: Patient Educational Brochure – Breast Reconstruction with
MENTOR® MemoryShape® Breast Implants and Quick Facts about Breast
Augmentation & Reconstruction with MENTOR® MemoryShape® Breast
Implants. For MENTOR® Saline-filled Implants: Saline-Filled Breast
Implants: Making an Informed Decision. These brochures are available
from your surgeon or visit www.mentorwwllc.com. It is important that you
read and understand these brochures when considering MENTOR® Breast
Implants.
The 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. CONTOUR
PROFILE® Expanders should not be used 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. Detailed information about
indications, contraindications, warnings, and precautions associated
with the use of CONTOUR PROFILE® Expanders are provided in the Product
Insert Data Sheet available online at www.mentorwwllc.com.
* Dr. Strock and Dr. Pacella are paid consultants to Mentor Worldwide LLC.
