As of November 17, 2006, women in the U.S. aged 22 and over have the option of choosing both saline and silicone gel filled breast implants. The first implants were filled with silicone gel. As breast implants evolved, saline (salt water) became an accepted alternative fill to silicone, although silicone can look and feel more like a real breast. Whether filled with silicone gel or salt water, the shell of both types is made of a firmer, silicone elastomer.
Background: In 1992, after decades of widespread availability of silicone gel-filled breast implants, FDA Commissioner David Kessler decided that the safety of silicone breast implants had not been established and had silicone breast implants removed from the market. For 15 years, silicone gel-filled implants were available only to breast reconstruction patients and patients undergoing breast revision surgery. In order to receive silicone, women had to enrolled in clinical trials mandated by the FDA.
The ban on silicone was lifted on November 17, 2006. To read articles about the FDA's approval of silicone gel breast implants.
Note: Soy filled implants are no longer available. The risk of infection on rupture from this substance was too high. Some claimed they also smelled bad!
A saline breast implant is a sac (implant shell) made of silicone elastomer (rubber), which is surgically implanted under your chest tissues and/or muscle, and then filled with saline, a saltwater solution, through a valve.
Breast implants have been used for breast augmentation for more than 40 years. Saline implants were long considered an inferior alternative to silicone gel-filled implants, which may look and feel more like a real breast than saline breast implants. Silicone implants were removed from the market by the FDA from 1992 to 2006 and saline (salt water) filled shells became an accepted alternative to silicone. Saline implants were approved by the FDA in 2000 and have always been available to women in the U.S. and worldwide.
Because of the FDA's ban on silicone for approximately 15 years, women had to be enrolled in clinical trials to get silicone implants. As a result, saline implants have been the most frequently used implants in the U.S. for cosmetic breast augmentation. With the availability of silicone as of November of 2006, those statistics may change.
Saline breast implants vary in shell surface (smooth or textured), volume / size (number of cc), shell thickness, profile and shape (round or anatomical), and are even available as expandable implants. Most saline implants are single lumen (only one chamber), and filled during surgery. Pre-filled saline implants were available for a short time but are no longer on the market.
Pros and Cons: Saline implants are more likely than silicone to cause visible rippling and are generally firmer to the touch and less natural in appearance than silicone gel breast implants. Saline implants are filled during surgery and allow the surgeon to make adjustments in the fill during surgery.
Overfilling past recommended manufacturer's guidelines can cause too much firmness. Not filling the implants sufficiently can cause the implant to have a fold which could lead to a failure of the implant know as crease fold failure. In the event of a rupture of a saline breast implant, saline is released and the empty implant can be removed and/or replaced.
Today's silicone gel breast implants are made differently than they were in the 1970s and 1980s. Initially, silicone gel breast implants had thick shells and thick silicone gel fills. In the 1970's, manufacturers began to use thinner shells, which were more likely to rupture. Today, both Mentor and Inamed make silicone implants with multiple layers of silicone elastomer surrounding the implant. This reduces the amount of gel bleed but can make the implants feel and look firmer. They are, however, much softer than saline.
Unlike saline breast implants, silicone gel breast implants are pre-filled. Surgeons order them in the requested size and they cannot be changed. Plastic surgeons have to make longer incisions in most cases to place a silicone gel filled breast implant than a saline filled breast implant, all other things being equal. The incision for silicone is 4cm compared to Saline which is 3cm, as there is not much difference in the size of the incision this is usually a small part in deciding which implant the patient chooses. Silicone implants cannot be placed endoscopically through a navel incision.
Prior to the early 1990's, silicone implants were used most often for breast augmentation surgery in San Diego and across the United States. Then, the "silicone implant scare" occurred, and the FDA removed silicone implants from routine breast augmentation surgery. Saline implants then became the standard for breast enlargements. Silicone implants never disappeared from the market, but their use was limited and based only on specific medical criteria. And, any patient who received silicone implants was required to participate in a long term study.
It can be said that the "silicone implant scare" was triggered by a combination of legal opportunism and some arguable medical "science", coupled with real patients' concerns over breast implant complications. After much debate, and based on extensive medical data, in November of 2006 silicone implants were once again approved by the FDA for use in breast enlargement surgery. The conclusion by the 13-member committee of the IOM (Institute of Medicine of the National Academy of Science) appointed by the Department of Health and Human Services of the US government determined the following at the end of the research:
"Evidence suggests diseases or conditions such as connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions are no more common in women with breast implants than in women without implants."
Both of the countries largest manufacturers of implants, Mentor and Allergan (formerly Inamed) contributed patient records to the implant study and both requested approval by the FDA of their newer silicone gels. And, both companies received approvals.
One of the restrictions included in the recent FDA approval is that the patient must be at least 22 years of age. And, not all types of silicone were approved for general use. For instance, the newer more cohesive implants commonly known as "gummy bear" implants require that the patient participate in a study. It does not mean the product is "unsafe", it just means that it wasn't one of the newer silicone products that made it into the November FDA approval. Both Mentor and Allergan are currently working with the FDA to get these implants added to the list of approved gels.
This FDA conclusion legitimized what most plastic surgeons already believed -- that silicone has always been a safe choice. You can find more information about the particulars of breast implants and the FDA approval by using this link: www.fda.gov/cdrh/breastimplants/qa2006.html.
There are significant improvements in the current gel implants. In the 1970's and 1980's silicone implants had a more liquid consistency inside and the outside shells were thinner and more apt to leak. Today the implants have outer shells that consist of several layers and are now made with an interior "cohesive" gel - one that is more stable and stronger. With the development of the newer gels there are also more implant "profile" choices for the patient helping to give the patients the "look" they want. The choice of multiple shapes and sizes are available in both saline and silicone implants.
Even though silicone implants now have approval from the FDA, saline implants are still a good choice for many women. Saline is available to women 18 years and older, unlike silicone where the minimum age is 22 years (that applies to simple breast augmentation). Saline implants, like their gel counterparts, have silicone shells, but the inside is filled with salt water instead of silicone gel.
So what are the advantages and disadvantages of each? One of the advantages of silicone implants is that they feel more natural to the touch and there tends to be less "rippling" around the edges of the implant. For women who are thin or have small breasts or stretched skin, this is a distinct advantage. One disadvantage of silicone is that the implants come pre-filled and a slightly longer incision is needed at surgery. So for those patients who want the shortest possible scar, saline implants are the only choice.
An advantage of saline implants is that the doctor is able to fill them after they are inserted into the breast pocket. These implants are ideal for patients who want smaller incisions -- examples being those who prefer a transaxillary or transumbilical breast augmentation. Also, if a saline implant should leak it becomes readily apparent as the saline is quickly absorbed by the body. Saline implants cost less than their silicone counterparts and this is frequently a consideration. Understand when making your choice that usually comparable and excellent results can be obtained with either type of implant.
So, if you are over 22 years of age, the decision is up to you. And, in our opinion, either choice is a good one. The best thing to do if you are thinking of having a breast enlargement is to meet with a board certified plastic surgeon. When the physician meets with you, the advantages and disadvantages of each approach will be discussed, based on your anatomy and personal feelings. The FDA approval of silicone implants has removed the silicone "fear factor" from the decision for most patients considering breast augmentation. Now patients have the ability to choose either saline or silicone and that's good!
If you would like to have a breast augmentation or wish to know more about breast enlargement surgery call make an appointment with one of a board certified plastic surgeons and discuss which choice is best for you. It is estimated that there are over one hundred board certified plastic in San Diego alone so you will be able to obtain good and helpful information by visiting a few of these surgeons and discussing your situation with them.
You might also find it helpful to visit the websites of the two implant manufacturers in the United States. Links to their websites are: www.mentorcorp.com and www.allergan.com.
Note: The specific risks and the suitability of breast enlargement surgery for a given individual can be determined only at the time of consultation with a surgeon. All procedures have some degree of risk. The information provided here is not a substitute for a consultation.
Both Dave Stringham & Michele Ellingsen are contributors for EditorialToday. The above articles have been edited for relevancy and timeliness. All write-ups, reviews, tips and guides published by EditorialToday.com and its partners or affiliates are for informational purposes only. They should not be used for any legal or any other type of advice. We do not endorse any author, contributor, writer or article posted by our team.
Dave Stringham has sinced written about articles on various topics from Tummy Tucks Before and After, Health and Breast Enlargements. Dave Stringham is the President of LookingYourBest.com an online resource for Learn more about breast augmenta. Dave Stringham's top article generates over 368000 views. to your Favourites.
Michele Ellingsen has sinced written about articles on various topics from Eyelid Surgery, Tummy Tucks Before and After and Breast Enlargements. Michele Ellingsen is the Vice-President of Business Development at the La Jolla Cosmetic Surgery Center, a state-of-the-art Center. For more informa. Michele Ellingsen's top article generates over 18100 views. to your Favourites.