Silicone Gel and Breast Implants - Dr. Brian Evans

About Silicone 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 post approval study following which will follow about 40,000 women for 10 years after receiving breast implants. The FDA often requires post market 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 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 post approval studies conducted by the companies.

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. 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 and gummy bear silicone implants, which are somewhat firmer. Another reason that textured silicone implants require 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).

Dr. Brian Evans Plastic Surgeon an experienced, board-certified plastic surgeon who specializes in breast augmentation can be invaluable in helping you decide how large you want to go. Dr. Brian Evans MD can evaluate your anatomy and take accurate measurements of your chest and breasts to determine the proper proportions for your frame. He will also take into account how lax, or loose, your skin is — an important consideration because, for an aesthetically pleasing augmentation, you must have enough tissue to cover the breast implants.
For more details please visit: http://drbrianevans.jimdo.com/