Breast implants safety information

Breast implants are not lifetime devices. The longer a woman has implants, the more likely it is that she will need to have surgery to remove them.

The most frequent complications and adverse outcomes experienced by breast implant patients include capsular contracture, reoperation, and implant removal (with or without replacement). Other common complications include implant rupture with deflation, wrinkling, asymmetry, scarring, pain, and infection. In addition, women with breast implants may have a very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL).

There is no apparent association between saline-filled breast implants and connective tissue disease, breast cancer, or reproductive problems. However, in order to rule out these and other rare complications, studies would need to be much larger and longer than those conducted so far.

Safety Studies

Each year, thousands of women undergo breast augmentation surgery and experience no major complications. However, one must fully understand the risks as well as the benefits of this procedure. A recent study with a follow-up of at least ten years showed that nearly 96 percent of women with saline-filled breast implants who were surveyed would make the same choice again. This study was performed at the University of Minnesota in consultation with the Food and Drug Administration (FDA). Of 450 patients, 93 percent reported they were satisfied or very satisfied with their breast implants, and 71 percent rated their breast implants as soft and natural.

After a comprehensive evaluation of the evidence for the Association of Silicon Breast Implants with human health conditions, the Institute of Medicine concluded in June that there is "no definitive evidence linking breast implants to cancer, neurological diseases, neurological problems or other systemic diseases."

Many of the changes to the breast following implantation should be considered irreversible. If it is necessary or one chooses to have the implants removed, there may be dimpling, puckering or wrinkling, or other changes to the breast. Breast implants may affect the ability to produce milk for breast feeding. Breast implants may not prevent your breasts from sagging after pregnancy.

Long-Term Effects

There are millions of women who have had this surgery done since the 1970s who continue to live in harmony with their implants.

Breast augmentation may not be a one-time surgery. It is possible that there will be a need for additional surgery and doctor visits over the course of your life.
Breast implants should not be considered lifetime devices. It is possible that a woman will undergo implant removal with or without replacement over the course of her life.

Sources:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071228.htm
http://www.breastaugmentation.com/safety.shtml

What is a breast implant?

Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction). They are also used in revision surgeries, which correct or improve the result of an original surgery.

There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, and shape (contour).

Saline-filled, silicone gel-filled, and alternative breast implants may be indicated for breast augmentation and/or breast reconstruction, which are defined as follows:

Breast augmentation. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of an original primary breast augmentation surgery (i.e., revision-augmentation).

Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of an original primary breast reconstruction surgery (i.e., revision-reconstruction).

Sources: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071228.htm

Breast Implants Style and Size

What Size Breast Implant Should I get ? 

This is an incredibly important question. Some people are sure that they would like to be  a full C and a mid D or a Double D. Others are more concerned that someone will notice and only want to make a conservative change.

A very important concept is that you do not want to make this decision based on a fear that someone will notice. If you want to go "incognito" wear more conservative clothing for a while. The goal is to look great in a bathing suit and a dress. Many "conservative" people are disappointed later that they didn't go large enough.

Bra cup size varies between manufacturers, styles and how you wear your bra. Different style bras fit differently. Some people wear their bra so that they bulge out of the top, others wear it so loosely that you can't  find their breast inside!

Never look at someone else's choice of implant. It's what you start with--- plus what you add--- superimposed upon the shape of your own body. The same size implant may look completely different on another person.

The variation is so great that I have my patients come to the office with a flat panel sports bra and we put different size implants in the bra in front of a mirror. I encourage them to bring bathing suits, dresses, and any other clothing that they like to wear. This really gives you a good idea of what you will look like at each size.

Due to differences in clothing a "C" cup is not always a "C". Looking in the mirror and seeing what you look like 300cc bigger is simple physics! Your present chest plus 300cc has to look very similar to what you will look like with 300cc implants.

Most of the implants that are chosen by my patients are between 250cc and 675cc. Some are smaller and some larger. The largest implant available legally today is 1200cc.

Formulas, standards and comparisons may work in theory, but we all know that if you ask two women with exactly the same size breast what size they are, one may be absolutely certain she is a C while the other is sure she is a D. I don't think that "standards" work!  Breast size is often "in the eye of the beholder!"

Be highly aware of the width of the implants. If you place implants flat on a table, there is little difference in the height. It isn't that larger implants will stick out that much more. The reall difference is in how big the space will be between your breasts. If you have a wide rib cage and nipples placed out to the sides and you pick small implants, there will be a huge gap between your new breasts. This is usually not what you want. It isn't about your height and weight. Its about your rib cage width and where your nipples are!

What are the choices of implant positions? 

The easiest surgical placement of the implant is under the breast tissue (submammary).

A slightly more difficult surgical placement is under the chest muscle (submuscular or subpectoral) but this position is associated with a lower incidence of capsule contracture and slightly less occurrence of rippling. There is more pain postoperatively than with a submammary placement.

What are the options for implant size? 

The ultimate size of the breast is mainly a personal decision by the patient. Cup size is an inexact estimate of the final size since cup sizes vary with the bra manufacturer and how tight or loose the patient wears her bra as well as how much breast tissue is already present. Describing the preferred cup size does aid the surgeon, but it also helps to look at pictures or photos to show the physician the desired final look.

The most accurate method of estimating the implant size (in ounces) is to fill a plastic bag with measured amounts of water and place in a bra with the patient's estimated cup size. One can see with the bra on and covered by a sweater what the final result will approximate.

Patients most often comment that, "I wish I had gone larger," although there is a rare patient who feels she is too large.

A sports bra holds the implants against your chest like your natural tissue will. "Trying On" the implants in front of a mirror with several different outfits, in my opinion, is the best way to proceed.

Source:
http://www.webplastics.com/breast9.htm
http://www.breastimplantsusa.com/plastic-surgery-articles/breast-augmentation-faq-78.htm

Types of Breast Implants

The main components of breast implants include:

- the shell (the outside layer, sometimes called the envelope or lumen)
- the filler (inserted into the shell)
- the patch (covers the hole where the filler is inserted into the shell)

Typically the shell is made of a single layer ("single lumen"), but some implants have a double layer — a shell within a shell ("double lumen").

Silicone Shells for Both Saline and Silicone Implants

Both silicone and saline breast implants have an outer shell made of silicone-rubber material. But when someone refers to a "silicone breast implant," they mean the filler of the implant, not the shell. Thera are two types of implants:

- saline filled, silicone-rubber shell
- silicone gel-filled, silicone-rubber shell

Generally, the silicone-rubber shell is made of:

- Cured long strands of silicones
- Approximately 20 percent finely powdered silica tightly bound to the silicone polymers
- Small amounts of other materials
- Saline Filled Breast Implants

Saline Filled Breast Implants

Saline implants are filled with a sterile saline solution — the same type of salt water used in general surgery and for other internal purposes.

There are several types of saline-filled breast implants. These types vary depending on whether saline is prefilled before breast surgery or is filled during surgery, and whether the volume of the implant is adjustable.

Common saline implants:

- Single lumen ("lumen" is the outside shell) — prefilled at the factory to a fixed volume. There are no valves for filling during surgery or for adjusting after surgery.
- Single lumen — filled with a fixed volume of saline during surgery through a valve. After surgery there are no adjustments to the implant volume.
- Single lumen — filled during surgery. After surgery, the volume of the implant can be adjusted by adding or extracting saline through a valve in the implant.

Silicone Gel-Filled Breast Implants

Silicone breast implants came on the market in 1962, but the FDA stopped sales of these implants in 1992 due to safety concerns. After a thorough investigation, the FDA re-approved silicone-gel filled implants in 2006.

These implants are now approved for women of all ages who need breast reconstruction and for women age 22 and older for breast augmentation. The reasoning behind the age restriction is that a woman's breast tissue is still developing into her 20s, and the powers-that-be at the FDA feel that women age 22 and older are more able to make informed, educated decisions than their younger counterparts.

The filler in silicone gel-filled breast implants is composed of silicone oil, cured large silicone, a small amount of uncured silicones and other materials. Silicone is a very safe compound and has been widely used in a number of medical applications for many decades.

There are several types of silicone-filled breast implants:

- Single lumen — prefilled by the manufacturer to a specific volume of silicone gel.
- Double lumen — the inner lumen is prefilled by the manufacturer to a specific volume of silicone gel. The outer lumen is filled during the breast augmentation procedure with a fixed volume of silicone gel using a valve in the implant.
- Double lumen — the outer lumen is prefilled at the manufacturer with a fixed volume of silicone gel, while the inner lumen is filled during the procedure through a valve in the implant. This third type allows for adjustments to the filler volume after surgery.
- The fourth type of silicone implant may appear to have no shell — looks and feels like a semi-solid rubber gel.

Source:
http://www.yourplasticsurgeryguide.com/breast-implants/implants-anatomy.htm

Breast Implants

Breast implant surgery can enhance the size and shape of your breasts. Because of improvements in surgical methods and breast-implant technology, this procedure has become more refined, providing better post-surgical results than years ago. This procedure may be combined with a breast lift to provide a fully satisfactory outcome.

Breast Implant Choices
Breast implants come in many sizes and shapes. The type of breast implant that you choose for surgery should be based on your desired change in profile and cleavage. Factors include positioning, surface texture, shape, personal anatomy and other considerations.

Saline Vs Silicone Breast Implants

Saline breast implants have been considered advantageous because if ruptured, the saline can be easily dissolved by the body. A disadvantage is that saline implants are more likely to show ripples through the skin.

Breast Implant Side Effects

As with any surgery, breast augmentation surgery has some associated risks. Though infrequent, complications can result in further treatment or a longer recovery. Risks associated with breast implant surgery could include obstructed mammography, breast feeding issues, infection, and possible implant leakage.

Source: http://www.yourplasticsurgeryguide.com