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Silicone Breast Implants

Silicone Gel Implants: A Brief History

Silicone gel breast implants received FDA approval on
Nov. 17, 2006. And while these implants are now regarded as
safe and effective, FDA monitoring of the products will
continue. Leading manufacturers of breast implants,
Mentor and Inamed, will be required to conduct a
10-year post-procedure study of 40,000 women who
have had augmentation surgery. Such studies are
commonly done to obtain information that can only be
determined after FDA-approved products have been used
for a set period of time and by a designated number of people.

This is especially helpful in the event that products are discovered to be ineffective or unsafe.
These implants received FDA approval after comprehensive reviews were done of the clinical and preclinical studies done on implants made by Mentor and Inamed. As part of the review, independent groups of scientists and advisory panels of experts met with hundreds of shareholders and listened to their comments and feedback. Moreover, FDA inspections were made of the facilities that manufactured silicone gel breast implants to ensure that the buildings were FDA-compliant with Good Manufacturing Practices. A percentage of the core studies indicated that there were problems such as hardening around the implants, pain in the breast, altered sensation in the nipple, and implant ruptures which necessitated revision augmentation surgery. But the majority of women questioned in these studies were pleased with the look and feel of their implants.
A number of independent studies have been conducted since 2000 to find out if there is any link between silicone gel implants and cancer or connective tissue disease. A report released by the Institute of Medicine states that there is no evidence to suggest that silicone gel implants cause either of these diseases. That said, the manufacturers of silicone gel implants have agreed to conduct post-approval studies among women to obtain more information about these issues.    

Silicone Gel

Silicon ranks second only to oxygen as one of the most plentiful elements on the planet, and can be found in rock, sand and quartz.  Silicon is turned into silicone when it is blended with oxygen, carbon and hydrogen.  And silicone is found in a number of forms. Certain oils are made from low-molecular weight silicones. Gels are formed by medium-weight silicones, and rubbers and elastomers can be created out of high-molecular weight silicones. Many types of implants are made from silicone, such as those used for artificial joints, facial implants, drainage systems, and more.
The silicone gel breast implants made by Mentor and Inamed have a silicone gel center surrounded by three layers of shell, which are designed to minimize any gel leakage. These shell layers have made the implants somewhat firmer than models made in the past. However, many women praise the silicone gel implants used today, saying they feel very natural.

A breast implant made from silicone gel is pre-filled with the substance, and no additional filling is required. Pre-filled implants have one distinct disadvantage, in that the incision used to insert them into the body may be slightly longer than for other types of implants, depending on the size of the implant used. Longer incisions are necessary for the firmer types of implants, such as textured silicone implants and so-called gummy bear implants.  

Interesting Facts About Silicone

Silicone isn’t limited to use in pre-filled breast implants, and can be found in a variety of other implants used throughout the body.  Silicone also has many other uses, such as: to make cardio-vascular prostheses, including heart valves; to make catheters, for delivering medications and for heart monitoring; for gastrointestinal conditions; for dental procedures; to boost nerve regeneration; for ear, nose and throat, and respiratory ailments; for skeletal prostheses; in ophthalmology; to expand tissue; as penile prostheses and for other urogenital tract conditions; to minimize scars and wrinkles; and much more.



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