F.A.Q.'s

Potential risks and complications.

There are inherent risks and complications with breast augmentation as there are with any surgery. You should be aware of the potential risks and discuss any concerns you may have with your doctor before your implant surgery is performed.

The following information is provided to you by Mentor and the FDA. It contains important facts regarding breast implants and the potential risks associated with them.

Information for women considering saline-filled breast implants.

Saline-filled breast implants (silicone envelopes filled with salt water) were already in use in 1976 when the Food and Drug Administration (FDA) began regulating medical devices. Under this 1976 law, manufacturers could continue selling devices already on the market ("grandfathered"). But the 1976 law made it clear that at some time in the future, the FDA would require manufacturers to submit their research data showing that these products are safe and effective.

Women need to know that until this call for research data occurs, laboratory, animal, and human tests on some of these 11 "grandfathered" products - including saline breast implants - may not have been completed by the manufacturer or reviewed by the FDA.

Women considering saline-filled breast implants for breast enlargement or reconstruction should receive the following information about implants (and, when appropriate, other options for reconstruction) before surgery is scheduled. This will allow them time to review the material and discuss possible risks and benefits with their doctor.

For some women, breast implants can improve their quality of life. Some breast cancer survivors believe that getting implants has been an important part of their recovery.

However, other women find external breast forms to be satisfactory. Reconstruction options include breast implants or surgery using tissue from a patient's own abdomen, back or buttocks to form a new breast. This surgery requires sufficient fat tissue and a longer operation, and like any other procedure, it is not always successful.

For each woman, whether her goal is augmentation or reconstruction, the benefits may be different. With her doctor's advice, each woman must decide whether or not she wishes to accept the possible risks in order to achieve the expected results.

Breast implant surgery presents the same general risks associated with anesthesia and any other surgery. After the surgery, there are other special risks related to saline-filled breast implants. (The manufacturer's package insert for these devices gives additional, more detailed information. Your doctor has a copy and can provide it to you.)

Most common risks.

Deflation: Breast implants cannot be expected to last forever. Some implants deflate (or rupture) in the first few months after being implanted and some deflate after several years; yet some seem to be intact 10 or more years after the surgery. It is not known when deflation is most likely to happen. The implant can break due to injury to the breast or through normal wear over time, releasing the saline (salt water) filling. Researchers are doing studies to determine rupture rates over time. Whenever a saline-filled implant does deflate, it usually happens quickly and requires surgery to remove and, if desired, replace the ruptured implant. Since salt water is naturally present in the body, the leaked saline from the implant will be absorbed by the body instead of being treated as foreign matter.

• Please click here to learn more about implant valves.
• Please click here to learn more about implant rupture.

Making breast cancer harder to find: The implant could interfere with finding breast cancer during mammography. It can "hide" suspicious-looking patches of tissue in the breast, making it difficult to interpret results. The implant may also make it difficult to perform mammography. Since the breast is squeezed during mammography, it is possible for an implant to rupture during the procedure. It is essential that every woman who has a breast implant tell her mammography technologist before the procedure. The technologist can use special techniques to minimize the possibility of rupture and to get the best possible views of the breast tissue. Because more x-ray views are necessary with these special techniques, women with breast implants will receive more radiation than women without implants who receive a normal exam. However, the benefit of the mammogram in finding cancer outweighs the risk of the additional x-rays.

Capsular contracture: The scar tissue or capsule that normally forms around the implant may tighten and squeeze the implant. This is called capsular contracture. Over several months to years, some women have changes in breast shape, hardness or pain as a result of this contraction. No good data is available on how often this happens. If these conditions are severe, more surgery may be needed to correct or remove the implants.

• Please click here for more information about Capsular contracture.

Other known risks.

Calcium deposits in the tissue around the implant: When calcium deposits, which are not harmful, occur, they can be seen on mammograms. These deposits must be identified as different from the calcium that is often a sign of breast cancer. Occasionally, it is necessary to surgically remove and examine a small amount of tissue to see whether or not it is cancer. This can frequently be done without removing the implant.

Additional surgeries: Women should understand there is a fairly high chance they will need to have additional surgery at some point to replace or remove the implant when and if it wears out. Also, problems such as deflation, capsular contracture, infection, shifting, and calcium deposits can require removal of the implants. Discuss the risk of these additional surgeries with your physician. Many women decide to have the implants replaced, but some women do not.

Infection: Infection can occur with any surgery. The frequency of infection with implant surgery is not known, but a prospective patient should ask her doctor what his or her experience has been. Most infections resulting from surgery appear within a few days to weeks after the operation. However, infection is possible at any time after surgery. Infections with foreign bodies present (such as implants) are harder to treat than infections in normal body tissues. If an infection does not respond to antibiotics, the implant may have to be removed. After the infection is treated, a new breast implant can usually be put in.

• Please click here to learn more about infection and Saline Implants.

Hematoma: A hematoma is a collection of blood inside the body (in this case, around the implant or around the incision). Swelling, pain and bruising may result. The chance of getting a hematoma is not known, but a woman thinking about breast implants should ask her doctor about his or her experience. If a hematoma occurs, it will usually be soon after surgery. (It can also occur at any time after injury to the breast.) Small hematomas are absorbed by the body, but large ones may have to be drained surgically for proper healing. Surgical draining causes scarring, which is minimal in most women.

Delayed wound healing: In rare instances, the implant stretches the skin abnormally, depriving it of blood supply and allowing the implant to push out through the skin. This complication usually requires additional surgery.

Changes in feeling in the nipple and breast: Feeling in the nipple and breast can increase or decrease after implant surgery. Changes in feeling can be temporary or permanent and may affect sexual response or the ability to nurse a baby. (See the paragraph on breast-feeding.)

Shifting of the implant: Sometimes an implant may shift from its initial placement, giving the breasts an unnatural look. An implant may become visible at the surface of the breast as a result of the device pushing through the layers of skin. Further surgery is needed to correct this problem. If the implant shifts, it may become possible to feel the implant through the skin. (Placing the implant beneath the muscle may help to minimize this problem.) Other problems with appearance could include incorrect implant size, visible scars, uneven appearance and wrinkling of the implant.

Unknown risks.

In addition to these known risks, there are unanswered questions about saline-filled breast implants. For example, can the implants bring on symptoms of autoimmune diseases such as lupus, scleroderma and rheumatoid arthritis? Can they bring on neurological symptoms similar to multiple sclerosis in some women? Can the implants increase the risks of cancer? (Because saline-filled implants contain only salt water, any risk that might be related to silicone gel would not occur with this type of product.)

There is some concern, but little information, about possible risks from the silicone rubber material of the envelope. Also, questions have been raised about the potential for the saline to become contaminated with fungus or bacteria. If so, these organisms might be released into the woman's body, if her implant deflated.

Autoimmune diseases: According to scientific studies, women with breast implants, in general, are not at an increased risk for autoimmune or connective tissue diseases. However, these studies are too small to detect whether there might be a slightly increased risk of any one of these rare diseases. Also, these current studies have looked only for the symptoms of known autoimmune diseases, rather than the variety of symptoms that some women report experiencing.

Some of the reported symptoms include:

• Swelling and/or joint pain or arthritis-like pain
• General aching
• Unusual hair loss
• Unexplained or unusual loss of energy
• Swollen glands or lymph nodes
• Greater chance of getting colds, viruses and flu
• Nausea, vomiting
• Irritable bowel syndrome Rash
• Memory problems, headaches
• Muscle weakness or burning

Breast-feeding and children: Questions have been raised about whether or not breast implants present safety concerns for nursing infants of women with breast implants. Some women with breast implants have reported health problems in their breast-fed children. Only very limited research has been conducted in this area, and at this time, there is no scientific evidence that this is a problem. It is not known if there are risks in nursing for a woman with breast implants or if the children of women with breast implants are more likely to have health problems.

• Please click here for safety information about breastfeeding with implants.

Is it necessary to wait until after having children before having breast augmentation?

No, although it is a matter of choice for each woman. In most cases, stretching or sagging is no greater with implants than in women who do not have implants. Therefore, this does not have to be a reason for a woman to put off enjoying the benefits of a breast augmentation until after having her children. Of course, if a woman is actively attempting to get pregnant, and it is a priority, it would make sense to wait until after the baby is born and she has stopped nursing.

Like all choices surrounding whether to get implants and the timing of breast augmentation surgery, this is a very personal decision.

Cancer: At this time, there is no scientific evidence that women with saline-filled breast implants are more susceptible to cancer than other women.

• Please click here to read about cancer-related questions.
• Please click here to read about mammography and implants

Who is eligible for Breast Implants? How old do I have to be to have an augmentation?

Women must be at least 18 years of age for breast augmentation.

Implants are contraindicated for women with:

• Existing Malignant or pre-malignant cancer of your breast without adequate treatment.
• Active infection anywhere in your body.
• Augmentation in women who are currently pregnant or nursing.

Is it painful? When can I return to work?

Well, you have just had surgery so obviously some degree of discomfort is always present. But in particular with breast augmentation, further discomfort may be added for the following reasons:

If the implants are placed under the muscle, the structure underneath is the ribs. If the rib perichondium is touched or bruised during surgery, then this will create discomfort and pain.

The second factor, is that the muscle will go into spasms and this further aggravates your discomfort.

This would explain why it hurts less if the implant is placed above the muscle. It is because you are no where near the ribs and the muscle does not go into spasms.

I explain the above so that if you understand why it occurs then we can try and improve the post-operative discomfort. In deed, because of a technique taught to me by Dr. Tebbetts, which address the above issues. Our recovery period and has been greatly enhanced through the unique use of certain exercises, ice packs and certain special medications that we give during and after surgery. Through this unique regimen most breast augmentation patients resume normal activities the next day and most return to work within 2-3 days. It is very unusual for our patients to require any type of pain medication for more than 48-72 hours. More specific instructions will be given to you during your consultation, but we will ask you to restrain from strenuous athletic activities for two weeks following your surgery.

If flying from out of town many patients will fly in one day early to enjoy south beach, have their surgery, and fly back two days later.

If you have nay questions and would like to see Dr. Mendieta in consultation please click here.

Should I wear a bra after my augmentation?

Most plastic surgeons will have a very different opinion on this issue, so the answer will be very dependent on your surgeons philosophy. In my practice I tend to vary what I tell patients depending on the progress of the healing and what I am trying to achieve.

Almost always I have them wear a sports bra for 2-3 weeks this is mainly for comfort since this gives support to the breast and they have less pain.

In the patient that I am concerned with the breast being to low, I will have them wear tape in the crease and a wired bra for 2-4 weeks.

In the patient that has very high ridding breast then I will have them wear some sort of superior strap that pushes the breast down and have them go bra-less. I avoid wired bras for 3-4 weeks.

In the patient that I feel the breast are too close then I place rolled gauze in the center of the chest and have them wear a support bra for 2-4 weeks.

If the implants are somewhat lateral and outward, then I will tape the breast laterally and have them wear a support bra for 2-4 weeks.

In the patient that is healing as expected then they can wear whatever feels more comfortable: wired bra, support bra, bra-less, etc.

Smooth vs. Textured What should I choose?

First of all, it is important to note that like many other decisions you will make in connection with your breast augmentation, this is one that you will need to make with your plastic surgeon. Given your own individual needs and special circumstances, there may be good reasons to go with one versus the other.

Textured Implants:

Capsular Contracture As early as the 1950s doctors had attempted to implant substances or devices to augment the breast, including sponges, body fat, etc. A problem that has persisted, despite the effectiveness of modern implant designs, is capsular contracture. Foam coverings and all types of solutions were attempted to prevent the scar tissue, which naturally forms around any foreign object, to become unacceptably hard (see FAQ on capsular contracture). The most recent evolution of the concept is textured surface implants, although a textured surface is not a new concept. Because of the way scar tissue forms around an implant, a textured surface is supposed to prevent scar tissue fibers from laying down uniformly in a parallel fashion and thus tightening up. According to a number of studies, a textured surface is not likely to reduce the risk of capsular contracture. Other studies find a reduction in contracture.

Anatomical Implants. Textured implants are also in order in most anatomical placements as the anatomical or contoured implant is meant to have a top and a bottom (it is tear drop shaped.) Without texture, the implant could flip, leaving the implant upside down and misshapen in appearance. While this can be corrected manually or surgically, it is not an ideal happening. A textured surface on the implant is intended to cause the tissue to adhere to the implant enough to prevent its free rotation.

Rippling, Deflation, Shell. One problem that causes many surgeons to not use textured implants is the apparent increase in the chance for visible rippling, according to many surgeons. The same characteristics of the textured surface that cause the scar tissue to form irregularly around the textured implant also cause it to appear rippled in appearance. A recent study also claims that textured implants have a higher deflation rate and are firmer to the appearance.

Smooth Implants:

Capsular Contracture. Due to the controversy over whether textured implants will actually reduce the rate of contracture significantly enough to warrant other potential disadvantages discussed above, doctors who prefer to use smooth, round implants quite often place them under the muscle. Placement under the muscle is also claimed to reduce the incidence of capsular contracture and this view is held by a consensus of surgeons.

Round Implants. Unlike anatomical implants, round implants do not require texture because they can rotate within the capsule and pocket without any change in appearance.

Rippling, Deflation, Shell. Proponents of smooth shell implants claim that they are less likely to cause visible rippling (especially if placed below the pectoral muscle) and more natural to the touch because they are made with thinner walls than the textured, anatomical implants.

Note: Round implants can be textured and anatomical implants can be smooth. However, it is usually recommended that anatomical implants be textured due to the potential for unacceptable rotation of the implant.