美国曼托(Mentor)公司的MemoryGel® XTRA硅胶

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.

49岁女性脂肪填充上睑后睑下垂10个月，脂肪源自自身大腿内侧，共计进行了两次注射，剂量未知。第二次注射后，出现双侧眼睑下垂。8个月时，对右侧眼睑进行过矫正手术，略有改善。之后就诊于本文作者，并进行了脂肪移除与推进上眼提肌筋膜。（AB）治疗前，检测发现左、右侧提肌分别偏移6mm与7mm；（CD）手术中，两个眼睑腱膜前区域有“脂肪团”，且纤维与周围组织连结（白箭头）。释放纤维并切除部分脂肪，待患者清醒后要求其睁开眼睛，评估是否推进上眼提肌筋膜，最终该患者右侧上眼提肌筋膜推进10mm，左侧推进8mm；（E）术后4天，效果可接受；（F）3个半月后发现左右不对称，左侧矫正不足，右侧矫正过度，而后对右侧进行了“释放”；（G）首次下垂矫正5个月后，患者左侧上眼提肌筋膜又推进2mm；（H）术后1年