History and Description of Silicone Breast Implants

Breast

History

Silicone breast implants were approved by the U.S. Food and Drug Administration for general usage in November 2006. They may be used on any woman aged 22 and older for both breast reconstruction and cosmetic breast augmentation. The operating surgeon must be certified to use silicone implants by undergoing specialized training. Our plastic surgeon at Rodeo Drive Plastic Surgery is fully certified to implant silicone gel breast implants.

Prior to their recent FDA approval, silicone implants were not routinely used in the U.S. since 1992. They had been banned by the FDA because of concerns of a link between silicone and connective tissue diseases such as arthritis and lupus. While they are now freely available, in the past they only could be used in select patients and by a plastic surgeon who was part of a scientific investigation of silicone breast implants. At Rodeo Drive Plastic Surgery in Beverly Hills, we were one of the designated investigators of silicone implants.

On April 10, 1991, FDA asked the manufacturers to submit evidence that silicone-filled breast implants were safe and effective. However, much of the information was not available. This did not necessarily mean that the breast implants were unsafe, but it did mean that FDA could not, as the law requires, confirm their safety.

With insufficient data on safety and effectiveness, FDA determined that silicone-filled breast implants could not be approved and could not be marketed for the purpose of breast augmentation in healthy women. However, under the law, FDA may extend its review period of devices already on the market if the agency determines that a continued availability of the device is necessary for the public health.

In April 1992, after a careful evaluation of the public health need, the alternatives to silicone-filled breast implants, and the known, potential and suspected risks, FDA reached the conclusion that silicone-filled breast implants should continue to be available for women seeking breast reconstruction because of their public health need. Finally, after more than ten years of rigorous study, the FDA determined that silicone implants posed no patient safety risk and approved them for general usage.

Safety

Since 1992, many studies have been done to look at the safety of silicone implants. These studies have not found a link between silicone breast implants and auto-immune diseases such as lupus and arthritis.

Materials

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.

The silicone gel breast implants of today are quite different than they were years ago. The early silicone gel breast implants had thick shells containing thick gels. These thick shells were replaced in the 70’s and 80’s with thinner shells. These shells had a higher rate of rupture.

Currently, Mentor and Inamed silicone implants have 3 layers of shell surrounding the implant. This reduces the amount of so-called gel bleed. It does, however, make the implants a bit firmer than they were years ago, but again, this is attributed to the thicker shell. Patients do tend to express the opinion that silicone implants are still very soft and natural feeling. However, the number of layers in the implant shell has no actual bearing on the integrity of the implant. The key factor is the chemical make-up of the shell wall, the strength of the material, and the optimal total thickness of the shell. Current implant shell walls are consistently strong with excellent impermeability.

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.

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; in the urogenital tract, including penile prostheses; and in many other applications.

Information courtesy of the National Library of Medicine and LookingYourBest.com

Back to Breast Augmentation Page