Silicone Gel Breast Implants Information
Silicone Gel Breast Implant Studies / Cohesive Silicone Gel Breast Implants

FDA Approves Silicone Gel Breast Implants

On November 17, 2006, the FDA approved silicone gel implants.  Now that the products have been determined to be safe and effective, the FDA will continue to monitor them by requiring each breast implant manufacturer (Mentor and Inamed)  to conduct a large postapproval study following which will follow about 40,000 women for 10 years after receiving breast implants.  The FDA often requires postmarket studies to answer important questions that can only be answered once a product is in broader use, such as the incidence of rare adverse events. 

The FDA’s decision to approve these implants was based on a thorough review of each company’s clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders.  In addition, the FDA conducted inspections of each company’s manufacturing facilities to determine that they comply with the FDA’s Good Manufacturing Practices.  Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery.  However, the majority of women in these studies reported being satisfied with their implants. 

In the past decade, a number of independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer.  The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases.  However, these issues will be addressed further in the postapproval studies conducted by the companies.

To learn more, please visit the following links:

Memory Gel - Mentor's website on Silicone Gel Breast Implants

Breast Implants Today - Inamed's website on Silicone Gel Breast implants

About Silicone Gel

Silicon is the second most abundant element on earth, next to oxygen.  Silicones are actually a family of chemical compounds.  They are made of silicon, which is a naturally occurring element found in sand, quartz, and rock.  When silicon is mixed with oxygen, hydrogen, and carbon, it becomes silicone.  Silicone can be made in a variety of forms.  Low molecular weight silicones form oils.  Middle molecular weight forms gels, and high molecular weight forms elastomers and rubbers. Silicone is found in many other types of implants, such as facial implants, artificial joints, drainage systems, etc.  

Currently, Mentor and Inamed  silicone implants have 3 layers of shell surrounding the silicone gel.  This reduces the amount of gel bleed.  It does, however, make the implants a bit firmer than they were years ago, but this is attributed to the thicker shell.  Speaking from my own personal experience with silicone gel breast implants, the silicone implants of today are still very soft and natural feeling.

Silicone gel breast implants come pre-filled, meaning that there is no fill to be added.  The only real drawback to a pre-filled implant is that the incision will have to be a bit longer, depending on the size of the implant to be inserted.  This is especially true for textured silicone, which is a somewhat firmer than the smooth silicone, due to the thickness of the shell.  Another reason that textured silicone requires a longer incision is the fact that the shell is textured.  Because silicone gel breast implants come pre-filled, they cannot be inserted via the TUBA incision (nor can any other type of pre-filled implant).  

 

Silicone is used not only in breast implants but also in implants located literally throughout every part of the body.  It has been used: to construct heart valves and other cardio-vascular prostheses; to fashion catheters which are used for purposes ranging from drug delivery to cardiac monitoring; in dentistry; in the gastrointestinal tract; as a facilitator for nerve regeneration; in ophthalmology; in the ear, nose, throat, and respiratory tract; as a prosthesis or ingredient in prostheses for many parts of the skeletal system; as a tissue expander; as a cosmetic agent for treatment of scars and wrinkles; in the urogenital tract, including penile prostheses; and in many other applications. Information courtesy of the National Library of Medicine

  
Becker Expandables - Double lumen saline / silicone gel reconstruction breast implant

It's very important to know the difference between the Becker Expandable and the Spectrum Expandable implant.  Dr. Hilton Becker, in conjunction with Mentor Corp., designed the Becker Expandable in 1984.  There are two types of Becker Expandable implants available.  They are the Classic Becker, and the Becker 50.  The Classic Becker has 75% saline in the inner lumen, and 25% gel in the outer lumen.  The Becker 50 has 50% saline in the inner lumen, and 50% gel in the outer lumen.  The saline is for expansion and fluid volume adjustment.  The Becker Classic is mainly a reconstructive device and can be used as a tissue expander, as well as a long term implant.  The gel in the outer lumen is for the soft feel, and less rippling under thin tissues.
 

The Becker Expandable was the first permanent tissue expander designed specifically for reconstructive purposes.  In the late 1980's, this implant/expander found it's way into general breast augmentation.  However, after the FDA imposed the moratorium on silicone gel breast implants, the use of the Becker Expandable was restricted, but was replaced with the Spectrum Expandable implant.  Becker Expandables are still in use, but due to cost ($2000 - $2200 per implant), they're really not suitable for general breast enlargement.  
 

 

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