Saline or Silicone Gel Implants

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Differences between Saline and Silicone breast implants

Breast implants are made from an outer shell and filling material. The outer shell can be either textured or smooth. There are different shape, size and profile options as well. We will outline each implant aspect here.

Outer Shell of Breast Implants

The shell of the implant is the outer layer that holds the filling. It may also be called the bag, or the envelope. In most cases the shell includes a valve and a patch that covers the spot where the filler is inserted.

The outer shells are made from silicone. This is true no matter what the filling is. However, the silicone used for the construction of the shell is not the same type of silicone used for the filler of silicone implants. They have different properties.

Dr Michael J Brown

In years past, the shell was quite fragile. This meant that many women had problems with the shell breaking. Today’s technology makes a much tougher shell. This reduces the risk of rupture.

breast implants virginia saline siliconeThere are two primary basic shapes for breast implants. It is best to think of them as being either round shaped or anatomic shaped.

For simplicity, the word ‘shaped’ is dropped and we use the term ’round’ for round, and ‘shaped’ for anatomic. The anatomic are also called ‘tear dropped’.

The round breast implants are the same measurements in height and width. So as the height increases so does the width. It is round. The breast implant is positioned in a larger pocket and designed to move around after the surgery. This provides a mobile breast mound.

The shaped implants do not share this characteristic. The height and width are different. Since they have an axis, they must be placed in a pocket that does not allow them to move around. They are also textured to help in not having them rotate. If the shaped breast implant does move out of position, breast implant malposition will occur.

breast implant surfacesSome implants are smooth, while others have a texture on the outside of the shell.  Using a textured implant has been shown to reduce the risk of capsular contracture and malrotation of shaped breast implants.

Capsular contracture relates to the layer of scar tissue that forms around the implant. The formation of scar tissue is to be expected; it is the body’s natural reaction. The area within the scar tissue is called the capsule. When the scar tissue hardens, thickens, or closes in on the implant, this is called capsular contracture. It can happen at any time. If it does, it usually requires surgery to repair. Textured implants in older silicone gel implants were shown to diminish contracture. No studies on today’s implants confirm these older studies.

Malrotation occurs when the implant rotates in such a way to cause it to appear misshapen or asymmetrical. Since the scar sticks to the surface of textured implants, this can reduce the implant’s ability to move inside the breast. This issue is more of a problem with tear-drop shaped implants; as such, tear-drop implants are always textured.

With these observations, textured implants are not the best choice for everyone. They have been shown to have an increased chance of failure. Smooth implants also have the advantage of allowing a more natural movement of the breast. Talk to your plastic surgeon about the pros and cons for your body type and implant type.

breast implant profilesThere are several size options for implants. The size is noted in cubic centimeters (ccs), such as 350 ccs. The implant needs to fit the width of the woman’s chest. For each width, there is a specific breast implant fill volume or range advised. It is important that the implant should not be too large for the woman’s chest. If it is, it will likely be visible through the skin. This can also cause more problems.

Size should be considered in conjunction with the profile of the implant. The profile refers to how flat or raised the implant will be when filled. The profile might also be called projection of the implant. There are low profile implants that have a flatter shape. These are not used often. There are medium or moderate profile implants. These are the most commonly-used. There are also high-profile implants. They are used less often. High profile implants can allow more saline to be used to fill them. However, they become narrower as they fill. This does not usually produce a desired look for most women.

There are differing measurements for different types of implants as well. For example, tear-drop implants will have a base size (the width), a height, and then a projection size as well. The width will be different at the top and bottom halves. The height is the length from the top most to the bottom most point. The projection is measured in the bottom half, where it is the greatest.

While every woman differs, in general adding between 175 and 200 ccs will increase the breast by around one cup size. However, this equation doesn’t hold for all body types, so use it with caution. Talk with your plastic surgeon to assess what size of implant will achieve your goals.

Filling or filler in Breast Implants

Within the US, there are two primary fillers for implants: saline or silicone gel. The filling is the primary component; most implants are named by their fill type. Even though all implants have a silicone outer shell, when someone mentions a silicone implant, they mean one that is filled with silicone gel.

Sterile saline filling is usually put into the device after it has been placed during surgery. This means the incision can be much smaller since the implant is inserted empty. Of course this means a smaller scar will result. Another advantage is that the fill amount can be tailored somewhat. Each implant has a recommended fill range. Some even come with special valves to allow the amount of saline to be adjusted after the surgery.

However, despite the surgical advantages, there are disadvantages too. For example, the saline implants are more likely to have visible rippling. They may also be more likely to be felt through the skin.

Silicone implants are pre-filled with a viscous, semi-solid silicone gel. This is not the same silicone as the shell. Since the implant is pre-filled, this results in the need for a larger incision. (Some saline implants may be pre-filled as well, but this is less common). Silicone implants typically have a softer feel than saline ones. Because of this, and to combat the problems of saline, many prefer silicone despite the larger scar.

Some may be wary of silicone implants because the FDA previously banned their use in 1992 due to safety concerns. (Silicone had been used in breast implants in the US since 1962). After studies were completed, silicone implants were again approved by the FDA in 2006. Three companies –Allergan, Mentor and Sientra – have been approved to create silicone implants for use today. (Dow Corning was put out of business during the controversy). Despite many lawsuits to the contrary, the FDA did not conclude that the implants were the cause of any major illness.

Saline became understandably much more popular during the time silicone was banned. While saline is still more prevalent, silicone is becoming increasingly popular since it was reintroduced in 2006.

Saline and silicone implants both have a risk of breaking. When the shell fails or forms a leak, the filling material leaks into the woman’s body. In the case of saline filling, the saline all leaks out. It is quickly absorbed and is harmless. The implant is left as just the deflated shell and must be removed or replaced. In the case of silicone filling, the rupture may not be immediately noticeable because the silicone does not move as easily. (It is thick semi-solid material, unlike liquid saline). If a woman is concerned about a failure, she can get an MRI to check for leakage.

Silicone gel breast implants have the best feel. Women think their breasts feel natural. In some women, saline breast implant rippling or implant wrinkling can be severe. Silicone gel breast implants tend to lessen this look. So in thin women, these silicone gel breast implants can be useful.

There has been a lot of ‘bad press’ about the safety of silicone gel breast implants. The majority of the controversy began in the ‘80’s. Women claimed their breast implants caused disease. They alleged the implants compromised their immune systems. Lawsuits and news reports prompted action. The breast implant manufacturers and the FDA withdrew the implants from the US. They wanted scientific proof of the silicone gel safety. In 2006, the FDA said there was enough data to support the safety of silicone gel. The FDA now allows the use of silicone gel implants for cosmetic breast augmentation. They have always been allowed breast cancer reconstruction. Dr. Brown was involved with the studies on silicone gel breast implants. He has many years of experience using silicone gel breast implants. Dr. Brown has used silicone gel breast implants since the early ’90’s.

Current use of silicone gel breast implants

Silicone gel breast implants are available to women who are:

  • at least 22 years of age
  • request breast augmentation using silicone gel breast implants
  • request a breast reconstruction to replace lost breast tissue

Patients under 22 can have them, but their use is ‘off-label’. This means that there is no manufacturer’s warranty.

The FDA is still following silicone gel breast implants. There is a 10-year study going on for women getting silicone gel breast implants. This implant study is to continue research on leaks and safety. It is also looking at the lifespan of the breast implants.

This is a silicone gel breast augmentation video. It is only two minutes long. There is no audio. For a longer video with audio, visit Dr. Brown’s YouTube channel.

Silicone gel breast implant construction and cohesive gel

Silicon is found in many things. It is found in sand, quartz, and rock. It is the second most abundant element on Earth. When it is mixed with other elements, it becomes silicone. Silicone can be made into many forms. Silicone is found in many other implants, such as facial implants, pacemakers, and catheters for chemotherapy.

Today’s silicone gel breast implants are cohesive. They are not liquid filled. The gel filler acts as a gummy solid. Cohesive gel clings to itself in the implant. Currently, silicone gel breast implants are available with a single shell and are pre-filled. This means a longer incision is required to place the implant. The length can be 4.5-5.5 cm. This is in contrast to saline breast implants. Saline are placed in empty and then filled. So a 3 cm incision can be used.

History & safety of silicone gel breast implants

The first breast enhancement took place in Germany in the 1800’s. The fat from a woman’s back and placed in her breast. Since then, various breast implant materials were tried. Japanese plastic surgeons were the first to use silicone for breast implants after World War II. They injected silicone directly into women’s breasts, which proved to be dangerous.

In the 60’s, two plastic surgeons made the silicone breast implant. Their implant consisted of a silicone rubber shell filled with a thick silicone gel. In ‘62, a woman received the first silicone breast implant. In ‘65, saline filled breast implants were introduced. In ‘76, the FDA passed the Medical Devices Amendment. This allowed it to review and approve the safety of new medical devices. Since silicone gel breast implants had been on the market for about 15 years, they were grandfathered in.

During the ‘70s and ‘80s, plastic surgeons gained more experience with breast implants. They found that women were pleased with the results of breast augmentation. In the ‘80s, an attorney won a lawsuit against silicone gel breast implants. The woman claimed that her ruptured silicone-gel breast implants caused her pain and suffering. By the late ‘80s, textured surface breast implants were made. The idea was that the textured shell would change how the scar tissue would form. This would reduce the risk of capsular contracture. Studies of the textured shell have shown mixed results as to if this is true or not.

In the ‘90s, the concern that silicone gel breast implants could be causing health issues became publicized. The breast implant manufacturer Dow Corning lost a lawsuit claiming that its breast implants were the cause of a woman’s being sick.

In ‘92, the FDA issued a breast implant suspension. The FDA banned the use of silicone gel breast implants for cosmetic breast augmentation. The exceptions for the continued use of silicone gel breast implants were:

This ban occurred because there was not enough safety information about silicone gel. Saline breast implants were safe.

In the early 2000’s, a report by the the National Academy of Sciences’ Institute of Medicine Report found no link between silicone gel breast implants and connective tissue diseases. The report stated:

…the committee noted that because there are more than 1.5 million adult women of all ages in the US with silicone gel breast implants, some of these women would be expected to develop connective tissue diseases, cancer, neurological diseases or other systemic complaints or conditions. Evidence suggests that such diseases or conditions are no more common in women with silicone gel breast implants than in women without breast implants”. In short, the report did not find any connection between silicone gel breast implants and systemic disease.

They concluded that the principal safety concerns for silicone gel breast implants are localized to the implant site and include:

The National Cancer Institute found ‘no increase in breast cancer related to breast implants’. So by this point, there are two major reports. One says no increase in disease. The other says no increase in cancer.

The Breast Implant Consumer Handbook was released by the FDA in 2004.It is about breast implants. It is to help patients in making decisions.

In 2006, the FDA voted to lift silicone gel breast implant restrictions. Silicone gel breast implants are now available.

Silicone gel breast implants limitations

Silicone gel breast implants limitations are:

  • they are pre-filled
  • the volume cannot be changed
  • breast size differences may be more difficult to match
  • larger silicone breast implants means larger incisions
  • lifespan of silicone gel breast implants is not known.

Silicone breast implants should be watched more closely and may need replacement. Studies are ongoing and with more data from breast MRI’s, plastic surgeons can make better estimates of how long silicone gel implants will last.

Silicone gel breast implants and immune system diseases and unknown risks

Illness has been reported in some women with silicone gel breast implants. Their symptoms are those of diseases of the immune system. As discussed above, there is no scientific evidence that silicone gel increases the risk of disease. However, the possibility cannot be ruled out. The effects of breast implants on patients already with connective tissue disorders is unknown

The risks related to silicone gel are not associated with saline breast implants. Saline filled breast implants only contain salt water. There is no gel fill. However, both types of implants have a silicone shell. Therefore, an increased risk of immune disease from saline breast implants may theoretically exist. How the implants would cause disease is not know. It has not been proven if the body creates cells to attack the silicone. There is little evidence to suggest that removing breast implants and scar tissue will change or prevent the occurrence of disease.

The current research is looking at known symptoms of immune diseases. These are not the same as the list of complaints from these women. The variety of the reported symptoms includes:

  • swelling and/or joint pain, arthritis-like pain;
  • general aching;
  • unusual hair loss;
  • unexplained loss of energy;
  • greater chance of getting colds, viruses, flu;
  • swollen glands or lymph nodes;
  • rash;
  • memory problems, headaches;
  • muscle weakness or burning;
  • nausea, vomiting;
  • irritable bowel syndrome;
  • fever.

You can see how this list is not specific. It would be very difficult to say that they are caused by one thing.

Platinum and silicone gel breast implants

Platinum is a metal used in the making of certain breast implants. Recent reports have found that small amounts of platinum leaks from certain silicone gel breast implants into surrounding tissue. Platinum may cause allergic reactions. There are concerns that leaks from the breast implants may be harmful. FDA scientists reviewed current studies on silicone gel breast implants and platinum leaks and did not find evidence that these factors cause illness.

Silicone gel implant bleed

Another concern of silicone gel breast implants is the leaking of small amounts of the silicone fluid or oil, through the shell. This would then leak into the breast tissue. This silicone fluid could cause complications. There is not enough information to conclude the degree of the health risks from silicone gel leaks or how to measure the amount of gel leak that would cause health risks. Studies have found that the chance of developing a connective tissue disease or related disorder caused by a breast implant is low. However, these studies have not resolved the question of whether silicone gel breast implants could possibly increase the risk of such disorders.