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Breast Implants Clinical Trials

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❶American Journal of Cosmetic Surgery.

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Saline and Silicone Breast Implants

Silicone implants — a silicone envelope filled with an elastic gel that feels much like natural breast tissue. If the implant leaks, the gel may remain within the implant shell or it may escape into the scar capsule area around the implant or even into the breast tissue.

A leaking implant filled with silicone gel may not collapse. Implants are placed behind the breast, not within the breast tissue. Implants can be inserted either:. Each position has its advantages and disadvantages.

Your Specialist Plastic Surgeon can provide further details and will recommend which position is likely to be most suitable for you. Breast augmentation is a highly individualised procedure and may not be suitable for everyone. Always talk to your Specialist Plastic Surgeon before making a decision. Your Specialist Plastic Surgeon will assess your condition and general health, and plan the treatment that is best suited to you.

Before you decide on breast augmentation with implants, there are some important issues to keep in mind:. Remember that the shape and size of your breasts before surgery will influence the surgical procedure and the outcome. Breast augmentation can be done under general or local anaesthesia, or twilight sedation. Discuss your options with your Specialist Plastic Surgeon.

Modern anaesthesia is safe and effective, but does have some risks. Ask your Specialist Plastic Surgeon and anaesthetist for more information. Make sure you have an up to date list before the surgery. Modern surgery is generally safe but does have the potential for risks and complications to occur.

Some possible complications and risks associated with breast augmentation may include:. There have been allegations that implants are linked to the development of connective-tissue diseases such as rheumatoid arthritis, lupus erythematosis, scleroderma and similar auto-immune conditions.

While some research has suggested small increased risks, many medical studies have not shown that the implants increase the risk of these problems. A proportion of all women in the community will develop these diseases, including women with implants..

The possibility of the development of connective-tissue and auto-immune diseases, even if remote, should be considered. Rarely, women with implants have reported general symptoms, including joint pain, general aching, swollen lymph glands, unusual tiredness, greater frequency of colds and flu, hair loss, rash, headaches, poor memory, nausea, muscle weakness, irritable bowel syndrome and fever.

The relationship of these symptoms to autoimmune disorders has been suggested but not proven. Implants may interfere with the detection of breast cancer using mammography, a type of X-ray examination. If you have had breast cancer, a family history of breast cancer or may have other risk factors for breast cancer, tell you Specialist Plastic Surgeon. There is no evidence that breast implants increase the risk of breast cancer, although the possibility has been considered.

It is important that you learn to self-examine your breasts for lumps, in addition to having any regular tests that are recommended by your doctor.

Your surgeon may also suggest a regular follow-up appointment for an examination of breasts for lumps and to assess the implants. Individual cases may vary but generally, mothers can breastfeed after having breast augmentation.

However, some women do experience reduced nipple sensation following breast augmentation surgery making it difficult to trigger the milk let down reflex. Some women may also experience reduced milk supply. If you are planning to breastfeed after breast augmentation surgery, talk to your Specialist Plastic Surgeon to get the latest information on this issue. The Registry collects relevant patient, surgeon, procedural and implant data relating to breast implants.

Choosing to become part of the BIR allows patients to be contacted should there be any concerns regarding breast implants. Depending upon your general health and the extent of the procedure, breast augmentation surgery can be performed either as a day case or alternatively with a short hospital stay. Your Specialist Plastic Surgeon will advise on the best option for you. You will also be asked to provide a complete medical history for your Specialist Plastic Surgeon including any health problems you have had, any medication you are taking or have taken, and any allergies you may have.

You may be advised to stop taking certain medicines such as non-steroidal anti-inflammatory drugs NSAIDs , aspirin, and medicines that contain aspirin. If you decide to have breast augmentation surgery, your surgeon will ask you to sign a consent form.

Make sure you read the consent form carefully before signing. If you have any questions, ask your surgeon. Unless your surgeon advises differently, you will be able to continue taking most medicines that you have been taking. Your surgeon will advise you if any other tests are required, such as blood tests, X-ray examinations or an Electrocardiograph ECG to assess your heart.

This may include pillows, ice packs, a thermometer and a telephone within easy reach. Make sure you arrange for a relative or friend to drive you to and from the hospital or clinic. Someone should also stay with you for at least 24 hours after you return home. Following your surgery, dressings or bandages may be applied to your incisions.

You may be wrapped in an elastic bandage or a compression garment to minimize swelling and to support your operation site as it heals. A small, thin tube may also be temporarily placed under the skin to drain any excess blood or fluid that may collect.

Depending on the extent of your procedure, you may need to take a few days off work to rest. Avoid heavy lifting, strenuous exercise, swimming and strenuous sports until advised by your surgeon.

Your surgeon will give you specific instructions on post-operative care. These instructions may include:. Be sure to ask your surgeon specific questions about what you can expect during your individual recovery period, such as:.

Scars are an inevitable part of any invasive surgery. Your Specialist Plastic Surgeon will endeavour to minimise scarring and to keep your scars as inconspicuous as possible by locating the incisions in easily hidden sites. That way, scars will be along natural skin lines and creases.

Scars may fade with time and become barely noticeable. If you are prone to scarring, you should advise your surgeon. Breast implants are not guaranteed to last a lifetime. Future surgery is often required to replace one or both implants.

As with all surgical procedures, revisional surgery may also be necessary to correct any problems that may develop. Cost is always a consideration in elective surgery. Prices for individual procedures can vary widely between Specialist Plastic Surgeons. Visit the Plastic Surgery Glossary for more medical terms. Australasian Foundation for Plastic Surgery Limited the Foundation is a not-for-profit organisation that supports quality health outcomes for everyone involved with Plastic Surgery, with a particular focus on rural and remote communities Australasian Foundation for Plastic Surgery Home.

Breast Augmentation Implants This website is intended to provide you with general information only. On April 10, , the FDA issued a regulation requiring manufacturers of silicone-gel-filled implants to submit information on their safety and effectiveness in order for the devices to continue to be marketed. In , the FDA banned most uses of silicone-filled implants because the manufacturers had not proved their safety.

In , the agency notified saline implant manufacturers that they, too, must submit safety and effectiveness data, although these implants were allowed to stay on the market. For many years, women had complained about the lack of information they received before implant surgery. Many said they had received no data on possible complications, pain, and the chance that the implant would not last forever. This lack of information was due, in part, to the fact that silicone breast implants were widely used before there was any requirement for research and documentation of the safety and effectiveness of medical devices.

In , the U. House of Representatives asked the federal Department of Health and Human Services to sponsor an extensive study of silicone breast implants. This comprehensive evaluation would include. To accomplish its task, the IOM set up a member committee—6 of them women—made up of distinguished members of the medical, scientific, and educational communities, with experience in radiology, women's health, neurology, oncology, silicone chemistry, rheumatology, immunology, epidemiology, internal medicine, and plastic surgery see list on inside back cover.

This was a group of volunteers, without conflicts of interest, and with no prior or current relationship with any implant lawsuits. An important task of the committee was to study and review thousands of published scientific reports. The committee also studied selected industry research reports on silicone breast implants and heard presentations from the public, including representatives of consumer groups, researchers, and women with silicone breast implants.

The committee's goals were to produce recommendations regarding the need for further research on the safety of silicone breast implants and to provide information to women with breast implants or who were considering breast implant surgery.

The committee's work resulted in a page report covering all aspects of silicone breast implants. An important goal of the committee was to provide to women all the known information about silicone breast implants. What follows are highlights from the committee's report, which it hopes will be of help not only to women considering breast implants but also to those who already have them. The committee focused on several issues of major concern to women regarding the safety of silicone breast implants, including their.

In addition, the committee reviewed available data about the safety of silicone when implanted in the body. Some of the committee's major findings are summarized below. Evidence clearly shows that silicone breast implants do not cause breast cancer or the recurrence of breast cancer. In fact, some studies suggest that women with breast implants have fewer new or recurring cancers.

For example, a large, year study of 3, women with cosmetic implants augmentation actually showed fewer cases of cancer 31 than would be expected 43 in a group of that size. The explanation for this lower-than-expected number of cancers is not clear. More studies should be conducted to determine whether or not the observation is valid and, if so, what might be contributing to the phenomenon. Originally, concerns about cancer arose from studies that linked implant-formulated silicone with the development of cancerous tumors in rats.

Such tumors can be induced if the implants are of a certain size, shape, and surface type and are made of a wide variety of substances, including glass and metal—not just silicone.

No studies have demonstrated that such tumors ever develop in humans. In addition, there is no evidence that silicone breast implants contribute to an increase in autoimmune connective tissue diseases.

These diseases cause the immune system, which fights any invasion into the body, to produce antibodies that attack the body's own tissues. Examples of autoimmune diseases are lupus, Raynaud's phenomenon a painful response of the hands and feet to cold , rheumatoid arthritis, and scleroderma, a disease that involves thickening of the skin. A report from the long-term Nurses' Health Study involving 87, women showed no link between implants and connective tissue disease or rheumatic conditions.

A review of 17 separate studies of the occurrence of connective tissue disease in the population was remarkable for the consistent finding of no elevated risk or no indication of an association of implants with disease.

Nor do animal studies support the idea of silicone-gel deposits as a cause of neurological disease. The committee did find that if an implant ruptures, localized problems such as scarring and nerve compression can occur in the breast or arm areas.

The committee also concluded that because there are more than 1. Evidence suggests that such diseases are no more common in women with breast implants than in women without them. A major concern about implants has been the possible adverse effects of silicone on breast-fed infants.

It is important to note that much higher levels of silicon—from which silicone is derived—have been found in cows' milk and commercially available infant formula than are found in the breast milk of women with implants. In fact, there is no evidence of elevated silicone levels in breast milk or any other substance that would be harmful to infants, nor are there any differences in silicone levels in the milk and blood of nursing mothers with implants and those without them.

Although some mothers with implants may find it difficult to produce an adequate milk supply, the committee urges that all mothers try breast-feeding, because it is beneficial to babies and is not harmful to mothers. Concerns have been raised about the possible harmful effects of silicone crossing the placenta to the developing fetus. The committee found no evidence of increased levels of disease or birth defects in children born to women with implants.

Contrary to some published reports, the committee found no significant evidence that implants interfere with radiation therapy. The implants showed good stability in reaction to any necessary radiation doses, and they did not interfere with radiation beams.

Evidence is limited that radiation therapy can cause capsular contracture shrinkage and distortion of the implant area and somewhat less pleasing cosmetic results, but there is the potential for concern. There have been many changes—and improvements—in silicone implants since they were first introduced in Although the time frame involved is relatively short, early results have caused many to believe that the implants of today offer greater protection from rupture or painful capsular contracture.

The majority of implants are now inserted behind instead of on top of the chest wall muscles that cover the breast area. Putting the implants behind the muscles lessens the chance of severe contracture, that is, shrinking and hardening of the tissue around the implant, and allows a better view of breast tissue when a woman has a mammogram.

The outside of the implant shell the elastomer is usually textured, also offering greater protection against contracture. The shell itself today is stronger, often with an additional inner barrier layer that helps guard against seepage. Saline implants were not very popular when they were first introduced. Another negative factor was the implant;s thin consistency, with wrinkling visible through the skin. But today's saline implants are much improved. The high rate of deflation has been corrected, and better cosmetic effects have been achieved by slightly overfilling the implant and placing it behind, or deep into, the chest muscles.

Some saline implants used in reconstruction have valves, designed to be inflated gradually after surgery as new tissue forms around the pocket created. Early valves often leaked, resulting in deflation or possible bacterial contamination of the saline. These problems, too, have been corrected. Recent studies indicate that a majority of women are satisfied with their implants.

Complaints to the FDA dropped sharply in , after peaking in the period from to , a time flame marked by numerous lawsuits and much negative publicity.

A foreign protein in the body is called an antigen, and many antigens are found in bacteria and viruses. The body reacts to the presence of an antigen by producing an antibody. T cells, a type of white blood cell, play an important part in defending the body against disease. When these defenders malfunction, the result is an autoimmune disorder—such as rheumatoid arthritis—in which the body's own cells and tissues are attacked. These disorders can be brought about by toxins that provoke the body into producing antibodies against itself.

There is no evidence, however, that silicone implants cause such a reaction. Antibodies are the body's normal way of dealing with foreign substances, and their presence doesn't necessarily indicate disease. The Independent Review Group, organized in the United Kingdom in response to women's concerns about silicone breast implants, concluded that, overall, silicones found in breast implants were bland substances with little toxicity and no adverse effect on the body's immune system.

The committee studied and evaluated multiple documents on the history, chemistry, and toxicology of silicone implants. It noted that the wide use of silicone—in foods, cosmetics, lubricants, and a variety of consumer products—has resulted in extensive exposure to it by individuals in all developed countries.

Almost all studies agree that there are baseline levels of silicon, an indicator for silicone, in normal breast and other tissue. Silicon is found in moderately higher than baseline levels around saline implants and in the capsules around silicone-gel implants. Silicon levels are particularly high around ruptured implants.

This silicon apparently does not travel to other parts of the body. The committee found that exposure of women to silicone from the breast implant is limited almost entirely to the implant, its capsule, and the tissue and lymph nodes immediately surrounding the area. The IOM committee concluded that the silicon found in distant tissues most likely reflects human exposure to the widespread presence of silicon and silicone in the environment.

At the end of its investigation, the IOM committee concluded that the silicones found in breast implants do not provide a basis for concern at doses reasonably to be expected. The committee also reported on its findings regarding the health problems that can occur in women with implants. Although generally not life threatening, such complications can cause discomfort and, in some cases, pose considerable risk. The IOM committee believes these local complications—which occur often and may themselves prompt additional medical procedures, including operations—are the primary safety issue with silicone breast implants.

The committee also recognizes that many of the reports reviewed in conducting this study were based on silicone-gel implants that were largely replaced by saline-filled implants in the early s, and the risk of local complications is likely even lower with saline-filled implants.

Finally, although breast surgery has a low risk of death, many complications can occur when implants are removed, revised, or replaced. The chances are great that most women will outlive their implants. The odds of having at least one replacement implant are high, and some women have had many more.

A smaller study of women with implant troubles showed that, on average, over 12 years there were about three implants performed per woman. The risks of having a local complication—such as a replacement operation—continue to accumulate over time. Women with gel-filled silicone implants and those undergoing reconstructive surgery appear to have a greater chance of complications than do women who have saline implants or implants for augmentation.

The operation for immediate reconstruction is more serious because it involves a significant surgical procedure mastectomy or removal of the breast followed by the implant procedure. This percentage may rise when an expander is used to help generate tissue growth in the breast area, and complications are probably more frequent when the woman has previously undergone radiation therapy.

The possibility of more frequent and serious side effects following immediate reconstruction must be weighed against the psychological benefits of such a procedure. Still, the frequencies are high. The IOM committee found that a large number of women with implants could expect to have an additional procedure within the first 5 years after the original implant. In addition, several studies indicate that removal of implants because of health fears is of little psychological value in relieving distress, depression, or anxiety.

Frequent local complications include the rupture of silicone-gel-filled implants, the deflation of saline-filled implants, severe contracture of fibrous tissue around the implant, infections, hematoma a pooling of clotted blood , pain, and implant displacement. The end result of these problems may be more surgery or other medical interventions. Such a rupture may be caused by tiny flaws in the shell or by inadvertent needle pricks while the incision is being stitched up.

Ruptures can also happen after a needle insertion a biopsy, for example or when the breast is severely squeezed or compressed either during procedures to break up fibrous tissue capsular contracture around the implant, or because of trauma caused by an automobile accident or even, some say, a too-tight hug. The implant shell may also weaken with time; in fact, this can be expected with older models.

With the rupture of a silicone-gel implant, the gel and fluid can sometimes escape into other tissues and even form an unwanted lump somewhere else on the body, such as the arm, armpit, or chest area. Often, however, the space between the fibrous capsule which forms around all implant shells and the implant can actually contain the gel, keeping it from spreading into surrounding tissue, so that the rupture goes unnoticed. Most surgeons believe this condition should be corrected. Surgery for extracapsular rupture consists of removal of the implant explantation as well as the capsule surrounding the implant capsulectomy.

These operations will require anesthesia, incisions, and stitches. And, of course, the surgical procedure may include a new implant as well.

The frequency of implant rupture is unknown. The IOM committee found studies reporting that the frequency of gel-filled implant ruptures varied from 0.

The extreme variability of these percentages is due to the type and model of the implants, their length of implantation, the types of groups of women studied, and many other factors.

Some reasons for the confusing statistics about ruptures are 1 ruptures are not always detected, 2 the composition of implants has undergone many changes over the years, and 3 the time interval varies and is not long enough to pick up late ruptures. Because of such conflicting information, the committee recommends further studies.

Further, the IOM committee concluded that it is unclear whether implants in current use will need replacement in 10 or 15 years, as some older models did, or will last longer.

DEFLATION It is usually very easy to spot a saline implant that has ruptured—within 2 or 3 days the harmless saltwater solution spills out into the surrounding tissue and the implant collapses, or deflates. Inflatable breast implants deflate with time. The report strongly recommends that more studies be conducted to answer questions about today's implant rupture and deflation rates. This buildup of tissue is called a capsular contracture.

If severe, it can cause painful and disfiguring squeezing as well as distortion of both the implant and the overlying tissue. The ensuing complications can be serious, including additional medical procedures to break down the overgrowth of protective tissue, or to remove it, or even to replace the implant itself. Additional surgery comes with its own risks, including infection, possible ruptures, and the hazards of anesthesia. The severity of contracture is often measured using the Baker Classification, which has four categories:.

View in own window. Most surgeons consider the first two classes satisfactory but not the last two. Women, however, have often tolerated Class III and IV contractures either by not seeking any medical help or by indicating, when asked, that they are satisfied with their implants.

This operation may also involve removal and replacement of the implant as well as loss of breast tissue. Replacement and capsulectomy also involve as much as an hour or more of operating time.

The IOM committee reports an excess use of some procedures, particularly the closed capsulotomy, in treating contracture. Repeated capsulotomy, open or closed, has progressively less chance of success. Contracture with its treatment is an important and incompletely resolved issue in breast surgery. It is likely that contracture is a progressive phenomenon, slowly increasing with time. Scientists and doctors do not know for sure why severe contracture happens.

Some have suggested that trauma to the breast during the implant surgery itself or at another time may bring about thickening and constriction of the capsule. The silicone used in implants has also been named as a culprit in contracture capsules formed around gel implants. The IOM committee noted that most studies agree that baseline levels of silicon are found in all normal breast and other tissue. Definite proof of a relationship between the presence of silicone in the tissue and contracture is lacking, but silicone fluid injected directly into the breasts an early and improper practice does cause fibrosis, or hardening of tissue.

Although definitive studies are limited, evidence suggests that saline-filled implants have a reduced rate of contracture compared to implants filled with silicone. Fewer cases of severe contracture are also reported in studies of textured-surface implants compared to those with smooth surfaces.

Both patients and doctors in a study preferred the textured surface. In one clinical study, women undergoing immediate reconstruction after mastectomy also showed fewer cases of contracture than did women having later reconstruction. And, after 5 years, contracture among reconstructed women in the study was less frequent than that among augmented women. However, the women with reconstruction had a much higher proportion of textured-surface implants and implants placed behind the chest muscles than did the women with augmentation.

This probably explains this unexpected result and suggests how effective texturing and placement can be in reducing contracture. Placement of the implant behind the chest muscles seems to lower the chance of contracture. The lower incidence of severe contracture with submuscular implant placement is important. The IOM committee believes patients and surgeons should consider this factor when discussing implant surgery options.

The use of steroids to reduce capsular contracture is not recommended. Steroids placed inside saline implants may carry other health risks and are not approved for use by the FDA. In addition, steroids may weaken the implant shell. The IOM committee recommends that any use of steroids should be postponed until carefully designed studies can be conducted to determine the risks and benefits of such use. Sometimes an infection can develop in the area where the surgery was performed, requiring medical treatment, additional surgery, and possibly removal or replacement of the implant.

Most local infections—those due to bacteria such as staph, for example—may be treated with antibiotics. These infections are reported most often in women who have had reconstruction, particularly immediate reconstruction after mastectomy. Sometimes infection can lodge in the expander used in some reconstructions. The ducts of breasts also collect some normal bacterial inhabitants of the skin area, and occasionally these may cause infection.

Infection may even contribute to the development of severe capsular contracture. The very medical procedures used to correct the condition may expose the area to more bacteria. The evidence that the presence of bacteria around an implant might contribute to contracture is not conclusive, but certainly suggestive. In a small number of cases, repeat operations have been necessary to correct the problem. Plastic surgeons often use drains after implant surgery to manage bleeding and the collection of blood hematoma or fluid around implants, and some surgeons claim such drains help prevent contracture.

Hematomas may occur, rarely, many years after the implant operation in association with contracture, perhaps because a stiff capsule has developed tiny fractures. The committee concluded that there is insufficient evidence pointing to more frequent contractures and subsequent complications around hematomas.

PAIN Pain is one of the significant reasons for implant removal and replacement, although few studies dealing with local implant problems have involved information about pain.

Some studies have reported that a majority of women do experience pain after implant surgery, and this pain may be long lasting. Patients also reported more pain with implants after mastectomies compared with mastectomies alone and with implants placed under the chest muscles instead of under the skin and breast glands. Formation of the implant capsule, especially when the implant is under the chest muscles, may cause nerve compression resulting in considerable pain that may require additional treatment.

The committee recognized that pain following surgery is not surprising given the damage that occurs to the nerves to the breast during implantation and reconstructive surgery, which in some cases occurs after injury to the nerves following mastectomy and, in some cases, lymph node surgery. Pain may also be an indicator of trouble ahead. Sometimes the implant has to be removed, or a capsule forming under the chest muscles may result in more compression and pain and lead to more surgical procedures.

Much of the pain with a late onset is caused by capsular contracture, but it can also be indicative of bacterial infections or rupture. The IOM committee's review of research and medical studies shows a local, but not general, reaction to silicone breast implants. Some women have expressed concern that the presence of an implant will make it difficult or impossible to use mammography for the early detection of breast cancer.

The committee reviewed available literature on the use of mammography in women with implants and also examined the usefulness of other imaging techniques for the detection of implant rupture. Mammograms—x-rays of the breast—have proved their value in finding breast cancer in its early stages. Randomized, controlled trials have confirmed that mammography significantly decreases breast cancer death rates. Women with cosmetic breast implants undergo mammography and other imaging techniques just as do women without implants.

In general, however, mammography is not necessary for reconstructed breasts because the breast tissue has been removed. Questions have come up about the possibility that the implant itself might obscure some breast tissue in augmented breasts, making an early diagnosis of breast cancer by mammography more difficult. No studies of women with breast implants have shown increases in cancer deaths because of mammographic diagnostic delay.

A large study of women with implants for augmentation actually showed fewer new cases of cancer than would be expected and also found the severity stage of these cancers at diagnosis to be about the same among women with and without implants. But the committee believes this question deserves further study.

The mammogram is an extremely important screening technique for finding breast cancer. All women in the age and risk categories appropriate for regular mammograms should continue to have them. The IOM committee realizes, however, that breasts augmented with implants can pose unique imaging problems, and that the success of the mammography depends in part on the experience and expertise of the technician.

A Woman's Guide to Breast Augmentation, Implants and Breast Health

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Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, Emily Moore, and Judith Faucette, JD, National Center for Health Research More than , women and teenagers underwent breast implant augmentation surgeries in

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Sep 04,  · Breast Augmentation Research. Published on. September 4, by Beauty by Dr. Cat Begovic. Share; Tweet; Pin; 1 shares. Recent publication in the Aesthetic Surgery Journal by Dr. Catherine Huang Begovic. One of the most common and disfiguring complications of breast implants is capsular contracture. This is scar 5/5(33).

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Thinking of doing a breast surgery? You need to do your research prior, thankfully we've done this research for you! Breast Augmentation in . Breast Implants Clinical Trials A listing of Breast Implants medical research trials actively recruiting patient volunteers. Search for closest city to find more detailed information on a research study in your area.

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Women can get breast implants to make their breasts bigger and fuller. That can be done for reconstructive purposes, such as after mastectomy for breast cancer, or for cosmetic reasons.. This. See a list of publications by Mayo Clinic authors on breast augmentation on PubMed, a service of the National Library of Medicine. By Mayo Clinic Staff Breast augmentation care at Mayo Clinic.