Saline And Silicone Breast Implants

Silicone breast implants have been available in the United States since the early 1960s. They were invented by two surgeons in Houston and rapidly became popular. Until 1976, there was no government agency with the authority to regulate implantable medical devices. The FDA was given that authority and decided to grandfather in breast implants as they had already been in wide use for a decade and a half.

Around 1991, people started asking questions about the safety and reliability of silicone breast implants, so the FDA went back to the manufacturers and said, "Listen, we're going to ask you to do what we should have probably asked you to do 15 years ago. You say these implants are safe. You need to set up studies and prove it."

So in essence, there is a misconception that silicone implants were "taken off the market". In actuality what happened is anyone who wished to have silicone implants had to meet one of three specific criteria and then enter into an FDA-approved study by the implant companies. Canada followed the U.S. lead. Keep in mind, South America, Europe and Asia felt no need to follow suit and added no restrictions whatsoever to silicone implant usage during the next 15 years.

In November of 2006, the FDA studied the results of the 15-year study and was satisfied with the safety of silicone implants. They have removed all restrictions on their use with the exception of age. The patient has to be 22 years of age or older in order to have silicone implants. During this lengthy time of study, there has never been a single scientifically done study implicating silicone implants with any of the diseases that were frequently discussed in the 1990s. Though silicone implants carry the same potential risks or complications as the saline implants, there is nothing inherently unstable that invokes a unique disease.

So, what is the science of silicone? Silicone is one of the most common elements on Earth. It is what sand is made of. It is what glass is made of. It is in every person living in the United States. It is in everything that we eat. When you pick up a box of salt at home there are only two ingredients: salt and calcium disilicate, which is added as a drying agent, which is why "when it rains if pours". So everything with salt in it has silicone in it as well. Silicone coats every needle, catheter tip, and syringe in a hospital. It is estimated that a diabetic giving himself insulin shots twice a day has more free silicone in his body than a woman with intact breast implants.

How is the choice to be made then between a saline and silicone breast implant? I have frequently remarked that a woman who has never had breast implants is going to be happy with either. However, a woman who has had both types of implants is going to have a preference for the silicone.

The only downside to the silicone implant is that it is a more expensive implant than the saline. However, there are numerous advantages. First it is resistant to showing rippling through the skin whereas a saline has that inherent property. This is why saline implants are virtually always placed under the breast and the muscle to try to hide that. Nevertheless, since the muscle only covers the upper middle third of the implant, when a woman with saline implants leans forward it is usually easy to see subtle rippling along the side of the breasts.

The silicone breast implant unquestionably feels softer and more lifelike than the saline which has a more water balloon feel for most people. In addition, even though the leakage rate for saline implant is quote low (under 1% per year), that leakage rate starts immediately after breast augmentation surgery. With silicone implants it is very unusual to have a leak in the first 10-12 years. That is not to say that they all suddenly start leaking. It is just uncommon in the first 10 or 12 years.

The silicone implant being softer and more passive has a lesser chance of being displaced out of the pocket requiring revisional surgery.

Advantages of the saline implant are its lower cost. In addition, some patients prefer a firmer, more augmented look, and saline implants can offer that. Also, the saline implants are inflated at the time of surgery, and so there can be some adjustment in the size during the operation for women who have some asymmetry or undergoing a procedure where the final desired size is not clear preoperatively.

Last of all, the FDA does recommend that women with silicone implants have an MRI to evaluate their integrity every three years. The FDA recommends this, but it is up to the individual patient whether she wishes to comply with that. In light of the fact that no other country recommends periodic MRIs and because of the fact that an MRI could actually suggest an implant is ruptured, when in fact it is intact, is the reason why the compliance rate for periodic MRIs is likely well under 10% of patients.

The silicone implants that we use today are far superior to what was available just five years ago. We only use American brand companies (Allergan and Mentor) and the implants are the so-called fifth generation implants. The material inside is known as cohesive gel or memory gel or "gummy bear gel". What that means is in the past when a silicone implant was cut in two the gel would leak out like syrup. The new implants we use have a different structure of the gel such that if an implant is cut in half it stays put like two blocks of Jello. So there is no capacity for silicone gel to migrate or move around in the body. Furthermore, the stories of silicone gel migrating over the body with the older implants were highly exaggerated. Whenever an implantable device is placed in the body (whether it be a breast implant, a joint replacement or a pacemaker) within the first week the patient's body makes a layer of tissue around it called a capsule. The capsule is the patient's own tissue. That is why when an implant leaked even 20 years ago it was almost always held within that pocket or capsule. The most common way a woman would find a silicone implant had leaked was accidentally through a mammogram or MRI.

I hope this has been helpful and useful information for you. You now know more than 99% of people in the world about silicone implants. We look forward to helping you through your entire decision-making process.