Silicone Gel Breast Implants Approved by FDA

This is great news for all women interested in having any kind of breast augmentation. On November 17, 2006, the Federal Drug Administration (FDA) approved the use of silicone gel breast implants for all women aged 22 and over.

Dr. Placik’s experience with silicone gel implants

Since 1990, I (Dr. Placik) have performed silicone gel placements for well over 15 years.

In 1994, I drafted a letter regarding the safety of silicone gel filled implants in nursing women which was published in the prestigious medical peer reviewed journal JAMA.

In 1995, I joined the practice of two plastic surgeons that had been previously carried out silicone breast enhancements since the 1960’s (over 40 years). Since 2000, I have been the sole plastic surgeon (in our practice) managing the care of all of our patients with silicone gel implants and have extensive experience with them.

From 2000 until the present, I have acted as the Primary Investigator for the Investigational Review Board at Northwest Community Hospital’s Adjunct Study Protocol for Mentor silicone gel filled implants. This has allowed me to continue to place these implants under the strict guidelines set forth by the FDA following the 1992 moratorium on silicone gel filled implants for cosmetic breast enlargement. While other plastic surgeons refused to participate due to the burdensome paperwork and bureaucracy, I have been overseeing the care (including surgical removal and replacement of implants) on individuals who had silicone implants placed prior to 1992 for cosmetic breast enhancement. After 1992, I have been carried out silicone breast enlargements for breast reconstruction after disease or injury.

After November 17th 2006, when the silicone gel implants were recently approved for cosmetic breast enhancement in women aged 22 and over, I completed both the Mentor and Allergan physician certification programs as mandated by the FDA.

Previous safety concerns satisfied

In 1992, the FDA restricted silicone gel implants to breast reconstruction and for a few other women for whom saline implants were a poor choice. This was prompted by the public perception during the 1970s & 1980s that silicone implants seemed to have a tendency to rupture and leak. Some people questioned whether these leaks were causing other medical conditions or diseases. In the 14 years since 1992, many studies have been done on the safety of silicone implants, and none has established any causative connection with any disease whatsoever.

Improved implants

The silicone implants now approved for general use have somewhat thicker shells than those used before 1992, and are filled with a thicker silicone gel. They come pre-filled in a variety of sizes, and are securely sealed so that there is virtually no chance of any leakage.

What is silicone?

The word silicone with an “e” at the end refers to a group of chemical compounds that vary in thickness from liquid to gels to a rubbery consistency. They contain, among other things, silicon, with no “e” at the end, which is an element, like nitrogen, carbon, or iron. It’s the second most common element on the planet, after oxygen. When combined with oxygen it forms silica, the most common substance on earth. We know silica in familiar forms, such as sand, quartz, and crystals. Silicone is used in many everyday items such as hand lotion, hairspray, soaps, processed foods and chewing gum.

The type of silicone gel used in breast implants has a consistency like jell-o, or thicker in some, so that it stays in one piece. If an implant shell were to rupture, the silicone gel would not run out like syrup or water, but would stay put. However, ruptures are now very unlikely.

Advantages of silicone gel implants

They closely resemble breast tissue and have a natural look and feel. They have fewer tendencies to ripple, in any way that could be seen or felt, than saline implants do. They also weigh a little less for each size than saline implants.

They come either round or teardrop-shaped, and with a smooth surface or a textured one. They can be inserted from the same incision locations as saline-filled implants. Those locations are:

In the armpit (transaxiliary)

Below the breast, in the crease (inframammary)

Below the nipple, where the skin changes color (areolar)

Since the silicone implants come pre-filled, the incision must be slightly longer than for saline implants, but is still small and well hidden. For more information about the implant procedure, see thebreast enlargement page.

The two companies whose silicone gel breast implants have been approved (because they’re the only two companies who have met all the FDA’s demands as to documentation and proof of safety), areMentor Corp. and Allergan Corp. (formerly called Inamed Corp.), which are both in California.

The implants manufactured by Mentor Corporation are called MemoryGel™ implants and have been in use for nearly 20 years, according to the Mentor website.

MemoryGel™ implants feature a cohesive, gelatin-like substance that acts as a solid rather than a liquid. It holds together uniformly while still retaining the natural give of breast tissue. From:

Allergan Corporation, the other manufacturer of the FDA’s approved silicone breast implants, offers its Inamed® silicone breast implants with strong confidence as to their safety and effectiveness:

Allergan has a global reputation of providing safe, effective and high quality breast options for over 25 years. Now, the FDA has evaluated and determined that INAMED® Silicone-Filled Breast Implants are safe for use in breast augmentation and reconstruction surgery. From:

Breast augmentation popular

Saline-filled implants have been effective and increasingly popular with American women. Now that we can choose either saline or silicone implants, breast augmentation is sure to become even more in demand. According to both the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society of Plastic Surgeons (ASPS), about 300,000 women opted to have breast augmentation during 2005. And further, almost 58,000 women had breast reconstruction. Many studies have shown that all types of breast enhancement bring psychological and physical benefits to those women who elect to have them done.

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If you would like to learn more about silicone gel breast implants, please call or email us. Dr. Placik offers initial consultations where he will listen to your concerns and desires, answer your questions, and suggest possibilities for helping you to reach your goals. Contact us today.