Silicone Implants FDA Gives Cohesive Gel the Green Light

By Leeann Morrissey © 2007-2009
PlasticSurgery.com Staff Writer

A good doctor will provide you with valuable information about breast augmentation; however, a great doctor will asses both your needs and your goals to help you determine what surgical path — if any — you should embark on. Your doctor should have your best interest in mind and help you develop realistic enhancement goals individualized to your body.

With technological advances in the medical field, plastic surgery is becoming more common. Breast augmentation surgery is one of the most requested procedures in the United States. According to the American Society of Plastic Surgeons (ASPS), more than a quarter of a million women underwent breast augmentation surgery in 2006.

Silicone Implants InformationThere are various reasons women desire breast implants. They are used to increase bust size, lift breasts that have begun to sag due to age, pregnancy or weight loss, or they can be used to recreate a breast that has been removed after a mastectomy. Each woman may have a different reason for wanting implants, but the end result should be the same — complete satisfaction.

Silicone Gel-Filled Breast Implants

In November 2006, the Food and Drug Administration (FDA) approved the use of silicone gel filled breast implants after 14 years of extensive study. Silicone breast implants were originally banned in 1992 because they were presumed to cause major illnesses, such as cancer and lupus. After thorough examination, it has been proven otherwise and two companies, Mentor Corporation and Allergan Corporation (formerly Inamed Corporation), have been approved to market their products. Allergan now provides the Inamed ® Silicone-Filled Breast Implants and Mentor offers MemoryGel ™.

Due to the long debate over the use of silicone, many women might still be confused about the safety of this newly-approved implant. Before you take a stance "for" or "against" silicone, consult a breast implant doctor.

Whether you are interested in silicone gel breast implants or saline, you still have a variety of factors to consider:

  • Cost: Is financing available?
  • Recovery: How long does it take?
  • Techniques: Is the implant inserted above or beneath the muscle?
  • Sizes: Will my new breasts look proportionate to my body?
  • Scars: Will they be extensive and noticeable?

These factors are relevant to both saline and silicone implants and may help to determine if breast enhancement is an option for you.

Since no device is foolproof, it is likely that the implants, both saline and silicone, will need to be replaced in the years to come.

Silicone Gel Breast ImplantsAlthough silicone is increasingly popular, saline implants provide some benefits that silicone cannot offer. Because the saline implant has a flexible fill volume, your doctor can make the necessary adjustments during surgery as opposed to the pre-set volume that silicone gel filled implants offer. For women with slight breast asymmetry, saline implants might allow for better precision (or "fine-tooth adjustment" according to PlasticSurgery.com‘s board certified medical reviewer Dr. Lisa Cassileth, a Beverly Hills plastic surgeon). Saline implant placement may also be placed through smaller scars because the implant is filled after it has been inserted. Silicone implants, on the other hand, typically require about a two-inch incision used for insertion; limiting a woman’s options for placement.

Silicone implants — which are made of cohesive gel — are available for wide use in the United States. These implants provide a natural look and feel. According to New York plastic surgeon Brad Jacobs, M.D., silicone gel implants are a "mechanical miracle." He says that this type of implant is designed to outlast the patient and they are less likely to require multiple replacement operations in the future, as compared to saline implants.

To ensure that silicone gel filled breast implants are indeed safe, the FDA is requiring that the manufacturing companies:

  • Conduct a large post-approval study (asking patients to undergo an MRI three years after surgery, and consistently every two years afterwards)
  • Continue their core studies for 10 years
  • Conduct a focus group study
  • Continue laboratory studies
  • Track each implant

According to Mentor, they have adhered to the highest standard of safety through testing and clinical trials. You and your doctor can review both Mentor and Allergan’s findings during a consultation.

Find a Breast Augmentation Surgeon!

Now that silicone gel breast implants have received the green light, we might see the number of breast augmentation surgeries soar in the years to come. Dr. Jacobs feels that silicone gel is the future of breast implants. "We are about to see the end of saline shortly," he said. But only time will tell if silicone will replace saline. What is for certain? Women need to find the best surgeons who they are most comfortable with.

In order to know if silicone gel implants are right for you, it is imperative that you find a plastic surgeon who is well-knowledgeable and experienced. Feel free to browse through our breast augmentation before and after photos to get an idea of how breast implants can be beneficial to your overall appearance.

PlasticSurgery.com can also help you locate a breast augmentation specialist in your area!