FDA approves a new silicone gel-filled breast implant : RushPRNews - Newswire & Global Press Release Distribution

 
Bookmark and Share

FDA approves a new silicone gel-filled breast implant

June 18, 2013

FDA approves a new silicone gel-filled breast implant

Silver Spring, MD (rushPRnews) 06/18/13 — Agency requires post-approval safety studies to assess rare events

 
The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. The MemoryShape Breast Implants are manufactured by Mentor Worldwide LLC.
 
The FDA’s approval is based on six years of data from 955 women demonstrating that there is a reasonable assurance of safety and effectiveness for this implant. Mentor’s MemoryShape Breast Implant showed similar rates of complications and outcomes as previously approved breast implants. These complications include tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and wrinkling. Fissures or cracks were observed in the gel of some MemoryShape Breast Implants, a characteristic called gel fracture.
 
“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
 
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren. “We will be looking at the results from post-approval studies that will focus on the implants’ long-term safety and effectiveness.”
 
The silicone gel in the MemoryShape Breast Implant contains more cross-linking compared to the silicone gel used in Mentor’s previously approved implant. Cross-linking refers to the bonds that link one silicone chain to another. This increased cross-linking results in a silicone gel that is firmer. The clinical significance of this type of silicone gel is not known. 
 
The FDA requires that Mentor conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease. Lessons learned from previous post-approval studies on silicone gel-filled breast implants informed the design of post-approval studies for Mentor’s MemoryShape Breast Implant.
 
As a condition of approval for the MemoryShape Breast Implants, Mentor must:
 
  • Continue to follow 955 women who received the MemoryShape Breast Implants as part of the pre-market core study that provided safety and effectiveness data for the device approval. These patients will be followed until they have completed their 10-year evaluations for long-term device performance;
 
  • Continue to follow approximately 350 subjects who were implanted with the MemoryShape Medium Height Moderate Profile (CPG Style 321) Breast Implants as part of a pre-market continued access study (not part of the pre-market core study). The patients will be followed until they have completed their 5-year evaluations;
 
  • Conduct a new study of approximately 2,500 women receiving MemoryShape Breast Implants to collect information on long-term local complications (e.g., capsular contracture, re-operation, removal of implant, implant rupture) and less common potential disease outcomes (e.g., rheumatoid arthritis, breast and lung cancer, reproductive complications). These patients will be followed for 10 years;  
 
  • Conduct five case control studies by enrolling 10,750 women to evaluate the potential association between any silicone gel-filled breast implant (including MemoryShape Breast Implants) and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma;
 
  • Evaluate women’s perceptions of the patient labeling; and
 
  • Analyze the MemoryShape Breast Implants that are removed from patients and returned to the manufacturer.
 
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast reconstruction or augmentation. These implants come in different sizes and styles and have either a smooth or textured silicone outer shell that is filled with silicone gel.
 
Breast reconstruction includes primary 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 abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
 
Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
 
With today’s approval, there are now five FDA-approved silicone gel-filled breast implant products available in the U.S. manufactured by three companies: Allergan, Mentor and Sientra.
 
Mentor Worldwide LLC is based in Santa Barbara, Calif.
For more information:
 
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
# # #

Media Contact Name: Morgan Liscinsky
Media Phone: 888-INFO-FDA
Media Web Address: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm356990.htm
Main image credits: FDA
About the author:

FDA is an agency within the Department of Health and Human Services and consists of seven centers and offices

Click here to see all news from this author/company

Filed Under: FDA- Pharmaceutical news, Lifestyle, PRESS RELEASE

RUSH PR NEWS newswire and press release services at rushprnews.com / AH Marketing ahmarketinggroup.com

Content- Legal Responsibility - All material is copyrighted - You may repost but you MUST link back to the original post on your page and acknowledge Rush PR News as the news source. Rush PR News is not legally and/or morally responsible for content of press releases, opinions expressed or fact-checking.

Rush PR News cannot be held legally responsible for material published and distributed through its newswire service or published in its press-room and therefore cannot be sued for published material. Third-party must be contacted directly to dispute content.

Rush PR News is not the contact for material published.

RSSFeed PRESS & SOCIAL MEDIA RELEASES

$20 Off PR Events Coupon. Publish Your Press Release Today

San Francisco 05/31/16 · RushPRNews' motto is PR Made Easy, and we are...

High-Tech Bridge Uncovers Large Number Of Fraudulent Cybersecurity Company Domains

San Francisco, US/ Geneva, Switzerland 05/26/16 · Research into the proliferation of fraudulent domains affecting...

Compliance Map tracks Country of Origin in complex supply chains

Solihull, United Kingdom 05/26/16 · The Compliance Map, a developer of environmental compliance...

Fast Lane Announces Global IT Security Training Partnership with NotSoSecure

Morrisville, NC 05/25/16 ·  - Business news -  Fast Lane Announces Global IT...

Publishing A Magazine To iPad Is Affordable With Twixl Publisher

Santa Cruz, California 05/21/16 · Fear Not: Solution is at hand to combat...

Losode.com making an impression in Virgin Media’s #VOOM 2016

London, United Kingdom 05/19/16 · Losode.com making an impression in Virgin Media’s  #VOOM...

Wayne Gretzky named A Great Canadian for the Canada D’Eh Run

Amherstburg ON 05/18/16 · Participants Voted And They Have Chosen The Great...

VOTE for Losode.com, an innovative fashion destination by Africans #VOOM 2016

LONDON, UK 05/16/16 · CROWDFUNDING CAMPAIGN-  Losode.com, an innovative fashion destination by...

Whom Can You Trust To Make Your Car Keys?

Toronto, Ontario 05/16/16 · Pop-A-Lock, the largest security network in North America,...

How to Fix Common Boiler Problems

Keighley, UK 05/14/16 · We ALL totally rely on our boilers to...

2016 Springtime Public Relations is Made Easy With PR Coupon

SAN FRANCISCO 05/14/16 · Spring 2016 is promising to be a time...

Fast Lane Joins the IoT Talent Consortium

Morrisville, NC 05/12/16 · - Fast Lane (www.fastlaneus.com) has accepted a role as an...

BOSS Mentors Give Local Young Women Entrepreneurial, Etiquette and Lifestyle Skills

Windsor, Ontario 05/10/16 ·  Best Opportunity to Support Self  – Manners and money...

Time to Replace Your Boiler Then Buy British with Ideal Boilers

Keighley, United Kingdom 05/05/16 · Ideal Boilers is a British Manufacturer based in...