This patient had breast augmentation prior to becoming pregnant. Left: After pregnancy, the breast implant position remains unchanged; however, the breasts have dropped. Right: After breast augmentation revision, the breasts have been lifted and the breast implants exchanged, dramatically improving the breasts' shape and profile.
Pregnancy and Breast Augmentation
Pregnancy can change the volume and shape of breasts, and the result isn’t always positive. If you have been pregnant, you know firsthand. For the lucky few the changes are subtle, or even enhancing, but usually they are not. Many patients opt for breast augmentation after having children to restore what was lost. If you are trying to get pregnant, it is worth delaying your breast augmentation; however, if childbearing is not imminent, waiting may not be desirable.
Breast Implant Problems After Pregnancy
The breast augmentation revision before and after pictures above are of a woman who had breast augmentation at a young age, and enjoyed her breast implants for many years. After childbearing, her breast implants remained in a perky position, but the natural breast tissue sagged. Her breasts would have sagged and deflated whether she had breast implants or not, but with implants the result was normal elongated, deflated breasts, with the addition of disproportionate upper pole fullness from her breast implants.
The Breast Implant Revision Solution
The solution was a breast lift with breast implant exchange. The natural breast tissue was lifted to reduce the length of the breast and firm the natural breast tissue. The breast implant was exchanged to help with both shape and the post-partum changes in breast volume. Larger breast implants can be used to replace lost breast volume. Smaller implants, removal of the breast implants, or even breast reduction can help when the breast remain too large after lactation.
A desire to change breast implant size (larger or smaller)
Deflation of the breast implant
Firmness due to tightening on the breast implant capsule (capsular contracture)
Breast implant asymmetry or malposition like bottoming out, double bubble or symmastia (uniboob)
If you have one of these problems, a Board Certified Plastic Surgeon, like Walnut Creek Breast Implant Specialist Joseph Mele, MD, FACS, can help.
Tomorrow, Dr. Mele will be appearing on Body Beautiful. The show airs live on KRON, channel 4, September 12, 2011, at 11:00 AM. Breast augmentation and breast augmentation revision surgery will be discussed. If you have questions, call in to the KRON studios on Monday at 11:00AM, or send us your question through the contact form on the left. Every effort will be made to answer your questions during the show.
Breast Implant Revision Videos
Below are links to previous television appearances on KRON4 featuring Breast Augmentation Revision Videos and Breast Augmentation Revision Before and After Photos:
Breast Augmentation Scar Revision Before and After Pictures
Breast Augmentation Scar revision is another reason for Breast Implant Revision Surgery. Follow the link for a case presentation of breast augmentation scar revision for a wide-spread periareolar scar : Hypertrophic Breast Scar Revision
Saline Breast Implants or Silicone Breast Implants? The question is asked every day in my Walnut Creek Plastic Surgery Office, and it is often followed by, “Which is Safe?” The decision to have breast augmentation surgery is a personal one. While both saline breast implants and silicone breast implants are both safe, which is best will depend on you.
Why Choose Silicone Breast Implants?
The main reason women choose silicone gel breast implants is because they feel softer. If you are thin and have small breasts, a breast implant will be more palpable. A silicone breast implant tends to give a softer, less detectable result. A silicone breast implant will move more like breast tissue too. These advantages are less pronounced for larger breasts.
Why Choose Saline Breast Implants?
The main reason my patients choose saline breast implants is because they are afraid of silicone. Saline implants are a bit firmer and can provide some additional projection when this is desired. They can also be placed through smaller incisions, because saline breast implants can be inserted empty, and filled after they are inside. The peace-of-mind that saline breast implants offer comes into play when we discuss breast implant leaks.
What Happens if My Breast Implants Leak?
Both the currently approved saline breast implants and silicone breast implants can leak. If and when the FDA gets around to approving the form-stable, gummi-bear breast implants, board certified plastic surgeons will be able to offer an implant that doesn’t leak. For now, leakage rates are low, but account for about one third of all breast implant revision surgery.
When Saline Breast Implants Leak
When a saline breast implant leaks it is obvious. The implant goes flat, and the volume is lost. No special test is necessary to make the diagnosis. Since saline is water with a little salt added to match your body’s saltiness, it is quickly absorbed and leaves no trace. US breast implant manufactures offer lifetime breast implant warranties, so the breast implant will be supplied without a charge, and if a leak occurs within 10 years of your primary breast augmentation, they will also supply money to help defray the cost of surgery to replace the defective implant.
When Silicone Gel Breast Implants Leak
When a silicone gel breast implants leaks, it may not be so obvious. The silicone is a cohesive gel and does not run like water. This is good in that the capsule around the implant often prevents the gel from migrating; however, it also means that the size of the breast does not change. The FDA has recommended that all patients with silicone breast implants obtain an MRI every other year to look for these silent leaks beginning three years after the initial surgery. If the gel migrates outside the capsule, the body will often form additional scar to wall-off the free gel. This can cause a lump in the breast and may be the first clue that a silicon breast implants has leaked.
So … Saline Breast Implants or Silicone Breast Implants?
There is no “correct” answer. For most patients a good result will be obtained with either saline breast implants or silicone breast implants. Silicone breast implants tend to give a more aesthetic result when the breast tissue is small and when the implant is large. The bigger the breast implant, and the smaller the breast, the more obvious breast augmentation may be. The silicone implants feels and acts more like breast tissue, so it can often provide a superior result in this situation. The advantage is not as pronounced if you have more breast tissue and a smaller breast implant.
While information is available on-line, the best way to get an informed opinion is by visiting a Board Certified Plastic Surgeon. If you would like to schedule an appointment with Dr. Mele give us a call at (925) 943-6353 or use the contact form in the left column.
It has been an interesting summer in the San Francisco Bay Area. The rest of the country is trying out the West Coast’s favorite natural disaster – Earthquakes. Earlier this week a 5.5 earthquake hit Cokedale, Colorado and a 5.8 struck in Mineral, Virginia. We are not slacking on that department, as I was awakened Tuesday night by a mild 3.6 quake, one of 75-100 San Francisco Bay Area Earthquakes this week.
Maybe it’s Earthquake weather, but this summer’s weather has been a bit odd. While the rest of the country has been roasting, it has been a mild summer for San Francisco. Bay Area Breast Augmentation, on the other hand, remains hot. In office procedures such as Botox, Fillers and Chemical Peels are still the most frequently performed facial enhancements, but Breast Augmentation (Augmentation Mammoplasty) remains the most popular cosmetic plastic surgery procedure, with 300,000 breast augmentations performed in 2010 just in the US.
Breast Augmentation Before and After Pictures
Reasons for Breast Augmentation
Breast Augmentation is performed for many different reasons, and the choice to get Breast Implants is a personal one. The most common reasons include the correction of breasts that never fully developed, restoring volume lost after pregnancy or weight loss, congenital deformities and the loss of a breast due to breast cancer. Breast Implants help restore body proportions, enhancing the way clothing fits. Some commonly asked questions about Breast Augmentation are answered on my main web site, and links are provided below.
If you are interested in learning more about Breast Augmentation, or you have Breast Implants and are considering Breast Augmentation Revision, give one of San Francisco Bay Area’s premier Breast Implant Specialists a call at (925) 943-6353, or contact us through the contact form in the left column.
The American College of Obstetricians and Gynecologists is Looking Out For You
Doctors are once again at odds with the government, but this time it has less to do with Obamacare, and everything to do with saving lives, possibly yours.
Mammograms Save Lives
We all know that Mammograms save lives. National Cancer Institute data show the US breast cancer death rate, previously unchanged for 50 years, has dropped 37 percent since mammograms became widespread in 1990. The US Preventive Services Task Force (USPST); however, doesn’t seem to get it.
Early Detection is Key
While a mammogram doesn’t treat breast cancer, it is the key to the early detection of breast cancer. Another key is routine monthly self-examinations. The combination is an effective way to detect breast cancer in its early stage. The earlier breast cancer is detected, the better the chance that treatment will lead to a cure.
Cure rates are greater than 90% for breast cancers detected early. Earlier detection means smaller tumors. Smaller breast cancers spread less often and are removed more easily. On the other hand, if breast cancer is discovery after it has left the breast, treatments rapidly become more complex and are dramatically less effective.
Doctors Fight Back For Their Patients
The American College of Obstetricians and Gynecologists (ACOG) recently issued new guidelines, joining a long list of physician lead professional societies strengthening the stand that early mammography saves lives. The new ACOG recommendations call for mammograms more frequently than the previous ACOG guidelines. The previous guidelines recommended mammography every one to two years beginning at age 40, and then annual mammograms after age 50. The new guidelines recommend:
Mammography yearly beginning at age 40
Monthly self-exams for women at high risk for breast cancer
US Preventive Services Task Force (USPST) Recommendations Deemed Unacceptable
When the USPST recommended against routine mammography for women younger than 50-years-old, it was in direct opposition to the current standard of care. The Major Medical Organizations in the US where at first shocked and then adamantly vocal in their opposition. The recommendation would mean less money spent on mammograms upfront; however, the “savings” would be lost later in trying to treat larger tumors that are more likely to have spread. The ultimate cost; however, would be measured in lives not saved.
Thank you ACOG
Thank you to the American College of Obstetricians and Gynecologists for joining the long list of professional medical organizations, including the American Society or Plastic Surgeons, who disagree with the government’s suggestion to wait until age 50.
USPST WT?
When the American College of Radiology and Society of Breast Imaging made it’s recommendation that mammography should start at age 40, they used the USPST’s own data against them. After careful review, the USPST’s data did not support the recommendation of delaying mammography until age 50. I applaud the efforts made by organized medicine to bring this information to light. How this remains outside the main stream media is puzzling. With major health care “reforms” underway, this is an excellent topic for an investigative report, and early mammography will certainly save more lives than knowing where Casey Anthony is hiding.
You Are Worth It
Mammography, while not pleasant, is an effective screening tool. With 80% of breast cancer occurring in women without a family history, it is important for every woman to have access to the exam. If the government recommends delaying mammography a decade, the next step will be to stop paying for it. If government programs stop paying for the service, all insurance companies will follow.
Mammography allows us to detect and control the spread of breast cancer. If we allow a guideline delaying mammography to become law, it will be much more difficult for your doctor to order this simple, lifesaving test. If the USPST gets its way, unless you are willing (and able) to pay for your own yearly mammograms, you won’t be getting them. Your government may not think it is worth the documented reduction in breast cancer deaths, but your doctors do.
Please support your doctors in their efforts. We strive to practice effective medicine and protect our patients. The Hippocratic Oath mandates that we doctors do no harm. The USPST mandate delaying mammography until after age 50 would do harm, and allowing the recommendation to go forward unchallenged, would be just as harmful.
Silicone gel filled breast implants were introduced to the US in 1962, and after 50 years of use, they remain among the most scrutinized medical devices currently available in the US. In June, 2011, the FDA released their Update on the Safety of Silicone Gel-Filled Breast Implants.
A Brief History of Breast Implants
1962 – Silicone gel-filled breast implants were introduced in the US. Prior to 1962, breast augmentation was performed with fat grafting or polyvinyl sponges.
1976 – US Congress passes the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Breast implants are classified as moderate risk (Class II) devices and required to comply with general controls and performance standards. The FDA reviews new breast implants through the 510(k) premarket notification process.
1980′s – Concerns are raised about associations between breast implants, particularly the silicone gel filled breast implants, and serious health issues such as breast cancer and systemic connective tissue disorders such as lupus, scleroderma and rheumatoid arthritis. The FDA reclassifies breast implants into Class III, higher-risk products needing premarket approval (PMA), and called for manufacturers to provide data demonstrating the devices were safe and effective.
1992 – The FDA decides that the manufacturers had not adequately addressed public concerns about certain complications. Rather than selecting the devices with a poor record, the FDA removes all silicone gel filled breast implants from the market, but only for elective cosmetic breast augmentation. The FDA continues to allow manufacturers to provide silicone gel filled implants for reconstruction after mastectomy, correction of congenital deformities, replacement of existing implants and for breast augmentation performed in conjunction with a breast lift. The Breast Implant Adjunct Studies were created, so that data could be collected about device performance and safety in these groups of women. In order to make breast implants again available for elective cosmetic breast augmentation, the FDA requires manufacturers to submit premarket approval applications that contained data on safety and effectiveness – like a new product. Europe follows the lead, but removes restrictions after 6 months, after reviewing the available literature and finding no links to serious systemic health issues.
1993 – The next generation of breast implants (Allergan Style 410 and Mentor Contour Profile Gel), textured, anatomic, highly cohesive (nearly form stable), silicone gel filled breast implants are complete, tested, and ready for submission for FDA studies in the United States and Europe … and Europe takes the lead.
1999 – The Institute of Medicine (IOM) releases a comprehensive report of the published literature and ongoing studies on breast implants, entitled Safety of Silicone Breast Implants. The study concludes that there is no evidence that silicone breast implants cause systemic health effects, such as cancer or autoimmune disease. Local complications (infection, bleeding, pain, deflation, capsular contracture, additional surgery) remain the primary safety issue with silicone breast implants.
2006 – The FDA approves Allergan’s Natrelle Silicone Gel Filled Breast Implants and Mentor’s MemoryGel Silicone Gel Filled Breast Implants. The FDA based its approvals on the manufacturers’ Core Studies. These clinical PMA studies followed hundreds of women with silicone gel filled breast implants for 4 years (Allergan) or 3 years (Mentor). The FDA determines that silicone filled breast implants are safe and effective and that the benefits and risks of breast implants were sufficiently well understood for women to make informed decisions about their use. As conditions of approval, the FDA requires both manufacturers to conduct six post-approval studies to investigate the long-term performance and safety of their silicone gel filled breast implants. From the FDA’s site these studies are:
Core Post-Approval Studies (Core Studies) – To assess long-term clinical performance of breast implants in women that enrolled in studies to support premarket approval applications. These studies were designed to follow women for 10 years after initial implantation.
Large Post-Approval Studies (Large Studies) – To assess long-term outcomes and identify rare adverse events by enrolling more than 40,000 silicone gel-filled breast implant patients and following them for 10-years.
Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices over a 10-year period.
Focus Group Studies – To improve the format and content of the patient labeling.
Annual Physician Informed Decision Survey (Informed Decision Study) – To monitor the process of how patient labeling is distributed to women considering silicone gel-filled breast implants.
Adjunct Studies – To provide performance and safety information about silicone gel-filled breast implants provided to U.S. women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.
2011 – The FDA releases the Update on the Safety of Silicone Gel-Filled Breast Implants. The conclusion: breast implants, while not perfect, remain safe and effective. The most common problems associated with breast implants remain: capsular contracture, reoperation and implant removal (with or without replacement). Other frequent complications include: implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of approval, and there remains no apparent association between silicone gel filled breast implants and connective tissue disease, breast cancer, or reproductive problems.
What’s Next in US Breast Implants
A “new” breast implant has been available in Europe since 1993, and despite many years of experience, it continues to await US approval by the FDA. These from stable breast implants also are not perfect; however, they have a lower local complication rate than any breast implant currently available on the US market. San Francisco Bay Area Breast Augmentation patients and Plastic Surgeons alike, want to know, when will “gummi-bear” breast implants finally be approved? The date of approval remains anybody’s guess.
What follows is a video segment from my recent television appearance on the Bay Area’s Local News Station, KRON4. I was originally scheduled to talk about Tummy Tucks (Abdominoplasty), but we kicked off the show with this important late breaking news update for women with breast implants. The (415) phone number in the video was for the live broadcast only. If you have questions about abdominoplasty, feel free to call my office directly at (925) 943-6353, or use the contact format the bottom of the column to the left.
This ALCL (Anaplastic Large Cell Lymphoma) update video includes:
Information from the January 2011 FDA White Paper
Why is it called a lymphoma?
Why ALCL is not breast cancer?
What are the symptoms of ALCL?
How is the diagnosis of ALCL made?
How rare is ALCL (34 cases in 10 million breast augmentation patients)
How is ALCL treated?
Do my implants need to be removed?
The important points to keep in mind:
ALCL is very rare.
ALCL presents with symptoms.
increasing size
swelling
discomfort
fluid around the implant.
ALCL is not breast cancer.
ALCL treatment is available.
If you have concerns with your breast implants, seek advise from a Board Certified Plastic Surgeon in your area. If you have the symptoms above, don’t panic, it is still unlikely that ALCL is the cause, and your local Board Certified Plastic Surgeon can help.
I will get the rest of the show up shortly for all of you interested San Francisco Bay Area Tummy Tuck patients. Once the tummy tuck videos are uploaded, I will place links below. In the interim, if you have have questions, or would like to schedule a consultation, please give me a call at (925) 943-6353 or use the contact form on the left.
Silicone is used in many beauty aids. While most people equate silicone with breast implants, there is much more to how silicone is used. From contact lenses to shampoo (dimethicone) silicone is around us every day. Silicone drainage tubes can be life saving after brain injuries to prevent fluid on the brain and death. Silicone implants are used throughout the body to improve both form and function. Most silicone implants are solid. Injection of free silicone is different than using silicone implants. Free silicone injections are liquid, and unlike with breast implants, the liquid is not contained.
Q: Is Silicone a Liquid or a Solid? A: Yes
Silicone is extremely flexible in its use. At body temperature, silicone can be made with a wide range viscosities: liquid like water, cohesive like honey, soft solid like Jello, more firm like rubber or hard like a rock. The fact that silicone is extremely well tolerated by the human body, makes it an excellent substance for implantation; however, only silicone meant for medical use should be used, and only by a qualified professional should be consulted.
How is Silicone Used
As a Board Certified San Francisco Bay Area Plastic Surgeon, I use silicone implants every day in my Walnut Creek Plastic Surgery practice. In California, silicone implants are used to augment the breast, cheeks, chin, nose and many other areas.
Silicone Facial implants are made of a soft solid silicone. Since they are solid, they cannot leak. They are used routinely for Cheek Augmentation, Chin Augmentation and Nose Augmentation. Since silicone facial implants are used to augment boney prominences, the fact that they are firm is an advantage. They can be molded into specialized shapes and sizes, depending on the amount and location of augmentation desired. The smooth surface does not adhere to normal tissue, so it needs to be meticulously placed. The smooth surface also allows for easy removal, should removal ever become necessary. Solid silicone facial implants are firm but flexible. For larger augmentations, silicone facial implants may not be firm enough.
An example: for small to moderate chin augmentation, silicone chin implants work great. For larger chin augmentations, I prefer Medpore®, which is made from porous high-density polyethylene. It is much firmer, and since it is porous, it allows in-growth. In-growth can help stabilize the Medpore® chin implant, and further decrease the already small risk of infection. These are decisions best made during your presonal consultation with a Board Certified Plastic Surgeon. This allows an open, honest discussion of the pros and cons of each option with a trained expert who has the experience to back-up your specific surgery.
Silicone Breast Implants
All breast implants have a silicone shell, even saline filled breast implants. When we say silicone breast implants we are talking about what is inside. Silicone breast implants have a solid outer shell, and a center filled with a cohesive silicone gel. Some older silicone breast implants were filled with a thin liquid, which would migrate if the shell ever broke. Currently, the cohesiveness varies from a very thick gel that likes to stay together (Allergan Natrelle® and Mentor Memory Gel® breast implants – currently available) to a solid with the consistency of Jello® (Gummy bear, Allergan Natrelle 410′s and Mentor Cohesive III Implants – Not yet FDA approved). These gummy bear implants can be made with various asymmetrical shapes, because they are thick enough to retain their shape.
Free Silicone Injections – Buyer Beware
The San Francisco Bay Area is a great place to be a plastic surgeon. We have an educated population that is interested and aware of many of the latest options in plastic surgery. Unfortunately, new doesn’t mean better, and sometimes new isn’t even new. Silicone injections are a great example. Even San Francisco plastic surgeons are still looking for the perfect injectable to fill wrinkles and augment the face without surgery. A well tolerated, stable substance, free from allergy, that will last a hundred years and remain soft remains elusive. There was a time when silicone was felt to be that substance.
Silicone is well tolerated, and can be made thick enough to prevent migration. The augmentation obtained is better than Restylane®, Juvederm®, Perlane®, Radiesse® or any other available dermal filler. It can remain soft for many years. Unfortunately, the body will form scar around free silicone, and this scar can continue to develop over years into a hard disfiguring mass.
Free Silicone in the Lips
Silicone has been used for lips. Initial results are great; however, the long term results are not predictable. Lisa Rinna, famous for her silicone augmented lips, recently had to have surgery to excise the silicone from her lips.
Free Silicone in the Buttocks
Silicone has been used for buttock augmentation. At first it looks great, but with time, it becomes hard and can cause visual disfigurement. Since medical grade silicone is not available in the United Stated, reports surface every year of an unqualified injector offering cheap buttock enhancement using silicone purchased at the local hardware store.
Free Silicone for Breast Augmentation
Free silicone was used for breast augmentation, as was fat injection, until they were replaced by a much more effective and safer alternative – breast implants. Breast implants use a solid silicone shell to contain the silicone inside. A thicker, more cohesive gel is used inside to help prevent migration, but even this should be removed if the implant breaks. Since the center is highly cohesive, it acts as a unit rather than a liquid, so it can be hard to tell if a silicone filled breast implant has leaked. This is why the FDA recommends women who have silicone gel breast implants obtain an MRI at three years and then every two years after having breast augmentation surgery.
“New” Silicone Injections
Research is on-going to find the perfect formulation for silicone injections. The latest attempts are looking into silicone with increased viscosity to help prevent migration and reduce the scar reaction. Since it often takes years for the scar around free silicone to develop into a noticeable mass, the results are still pending. One problem is that the thicker gel is much more difficult to inject without resorting to something like a caulking gun. Until the known problems are solved, the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery and the FDA do not approve of the use of silicone injections outside of clinical trials.
Tubular breast deformity is a common, congenital breast abnormality found in both women and men. In men, the treatment is straight forward (see the bottom of this article). In women, however, additional aesthetic norms come into play, making the repair more complex.
Tubular Breast Deformity in Women
Tubular breast deformity is known by many names:
Tubular breast deformity
Tuberous breast deformity
Snoopy Nose or Snoopy’s Nose deformity
Constricted breast deformity
Women with mild constriction often come to see me to simply increase the size of their breast, not aware of the diagnosis. Women with more severe deformity, however, are often reluctant to show their breasts to others, and want to improve the size and the shape of their breasts. Correcting these types of problems is more challenging, but at the same time, quite rewarding.
Mild tubular breast deformity with constricted base was corrected with sub-pectoral breast augmentation (behind the muscle) and internal release (no lift needed)
Tubular Breast Abnormality is a Congenital Breast Deformity
While present at birth, the full extent of the tubular breast deformity is often not appreciated until puberty. This is when the breasts normally develop, and the full extend of abnormalities are revealed. While women with tubular breasts have smaller than average sized breasts, not all small breasts are tubular breasts. While the extent to which the deformities manifest can vary widely, several specific abnormalities are present.
Signs and Presentation of Tubular Breast Abnormality
Besides smaller size, the main components of the tubular breast are a constricted base and a tubular shape to the breast. This can be exacerbated by herniation of the breast tissue into the areola, causing “puffy nipples”. Technically, the nipple is not affected, but the areola, the colored skin around the nipple, may project out from the breast mound. The overall effect is an elongated or tubular shape to the breast. The true tubular shape is most noticeable in more severe cases.
The colloquial name for tuberous breasts is the Snoopy Nose or Snoopy’s Nose deformity. Snoopy is Charlie Brown’s white beagle of Peanuts fame. Picture the front of Snoopy’s muzzle. If you are not familiar with Snoopy click the link above. His white face represents the breast mound, his black nose sits like a ball on the end, and represents the herniated breast tissue filling the areola.
Treatment of the Tuberous Breasts
As mentioned above, tubular breasts tend to not fully develop. Often patients with tubular breasts desire breast augmentation to increase the size of their breasts. For mild tubular breast deformity, a breast implant may be sufficient treatment. When the breasts are more tubular, additional maneuvers are necessary to provide an enhanced result.
If the areola is overly full, a periareolar lift can reduce the puffy nipples, and prevent the breast tissue from herniating. Unlike for men, the breast tissue is not usually removed, just pushed back into its normal anatomical position. The constricted base seen with tuberous breasts also tends to shorten the distance between the areola and the base of the breast. The lift has the additional benefit of moving the areola higher on the breast, helping to center the nipple on the breast mound.
Moderate tubular breast deformity with constricted base, elongated breast and mild areolar breast tissue herniation, best seen in right breast (your left). Both size and shape were corrected with breast augmentation and peri-areolar lifts.
Traditionally, tubular breast were treated with breast implants placed in front of the muscle. With a periareolar lift, it usually possible to place the implant behind the muscle. This gives a more natural appearing breast mound, and makes it easier to perform mammography in the future. While silicone and saline breast implants can both give good looking results, for smaller breast, a silicone gel implant may give a better feeling result. It is important to discuss the pro’s and con’s of each option with your Board Certified Plastic Surgeon.
Tubular Breast Deformity in Men
In men, tubular breast deformity presents as an overly full areola or “puffy nipples”. Since men like flat chests, tuberous breasts are easily treated in with resection of the excess tissue. The procedure is similar to that used for Gynecomastia. A small “smiley-face” incision is made from 4 to 8 o’clock around the lower edge of the areola, and the excess glandular tissue is removed. The procedure provides a smoother contour, and a quick recovery.
Screening mammography, an important part of breast cancer diagnosis.
Remember when the revised US Preventative Service Task Force (USPSTF) recommendations for breast cancer screening were released in November 2009? Like the recent FDA White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants, the USPSTF caused quite a stir. A the heart of the controversy was the USPSTF’s advice against the long time recommendation for routine screening mammograms for women beginning at age 40. The USPSTF recommended delaying routine screening until age 50.
Immediately, cash strapped county health organizations and large HMO organizations alike, debated cutting dollars to fund screening mammograms for women under 50. Meanwhile, a large number of US health care organizations, including the American Society of Plastic Surgeons (ASPS), the American Cancer Society (ACS), the American College of Radiology (ACR), and the American College of Obstetricians and Gynecologists (ACOG), recommended that physicians and patients continue to follow earlier guidelines. They recommended to continue screening mammography for patients aged 40 to 49, despite the government committee’s recommendation to start at age 50. The recommendation to continue screening at 40 was based on all previous studies showing a benefit to finding early breast cancer.
40 is Still the Right Age for a Screening Mammogram
Two years later, the advice to continue screening mammograms at age 40 seems to have been right on the mark. I don’t think this comes as a surprise to anyone who cares for women with breast cancer; however, a study published in the American Journal of Radiology, which analyzed the same data as the USPSTF concurs with the earlier guidelines. According to the analysis, women who receive annual mammograms starting at age 40 can significantly reduce the risk of dying from breast cancer by 71 percent. This is in stark contrast to women who follow the USPSTF recommendations, who had only a 23.2-percent reduction in mortality.
What Have We Learned?
The lesson here is not that government is bad, but that science is good. The practice of medicine is based on the odds of something helping more than it hurts. While studies may at times seem to offer conflicting advice, carefully analyzing the details can often resolve the issue. In this case, the data used in the USPSTF study was used to prove the point. So ladies, if you are 40, it is time to get your mammogram.
How Does Science Work?
The best scientific tool we have is the prospective, randomized, controlled, blinded study. But what does that mean?
Prospective: the study is planned before the data is collected. In this way, data known to be conflicting can be accounted for, and will be less likely to distort the results. The opposite of a prospective study is a retrospective study, where data from the past, often not collected in the best way possible, is used to evaluate a treatment plan.
Randomized: patients are randomly selected to enter the treatment groups. This is very important. This allows for equity in the treated and untreated groups. For example, patients with a family history of breast cancer tend to have a higher incidence of breast cancer. If all patients with a family history of breast cancer elected to have early mammograms, as one would expect them to, the incidence of breast cancer would be higher in the group that received early mammograms. Without additional information, it would be assumed that mammograms caused more breast cancer. This would not be true, but the data would support it, because of the way the study was designed.
If patients are randomly assigned to the early and late mammogram groups, patients with a family history would be randomly (evenly) distributed between the two groups. The net effect would be the same expected incidence of breast cancer in both groups. In a randomized study, if the group with early mammograms had more breast cancer, it would indicate that the mammograms may be causing the problem. This is not what randomized studies show. We know that mammograms require radiation, and radiation can cause cancer; however, for all studies done, mammograms find and cure more breast cancer than they cause for women over 40.
Controlled: A control group is a group that is compared to treatment under study. If you have a new treatment, and you want to prove that is provides a benefit, you need to compare a group of patients receiving the new treatment to a group receiving the current treatment. The current treatment group serves as the control group. Comparing a new treatment to no treatment, may show that the new treatment is better than nothing, but it will not prove that is better than the currently accepted treatment without the head-to-head comparison.
Blinded: Blinded studies are designed so that the patients do not know which treatment they are receiving. Sometimes the doctors and health professional conducting the study are kept in the dark too. This is to prevent investigator bias, and to help randomize the placebo effect.
The Ideal Study for Screening Mammograms at Age 40
The mammogram on left is of normal glandular breast tissue. The white circle in the mammogram on the right is breast cancer.
So, the ideal test to prove the benefit of mammograms to screen for breast cancer between ages 40 to 49 would need the following under each of the categories described above:
Prospective: Before the study is started, protocol is established. This would include who would be studied (women age 40) and what conditions would be excluded (men, women who already have breast cancer, women with other severe health problems). The number of women needed to prove statistical significance. Reasons for dropping out, and how to handle the data collected for those dropping out. It might be good to estimate the number expected to drop out, so that the remaining groups could still show statistical significance.
Randomized: How women are selected to be in each group. Toss of a coin, even or odd days of birth, anything unrelated to the mammograms or breast cancer, so that the two groups will be as equal as possible in all the variables that are not being controlled.
Controlled: A definition of the control group is established. In this case, the control group needs to be matched for age, family history of breast cancer, smoking, weight and all other variables known to contribute to breast cancer. This way the study group receiving the mammograms, and the control group not receiving the mammograms, will be as equal as humanly possible.
Blinded: While not likely in this type of study, the best control group would do everything the study group does except get mammograms. A clever sham for the control group, would be to use mammogram machine, have it make a noise like a mammogram was done, but not use any radiation. No mammogram would be taken, but it would not be possible for the patient, and in some cases, even the mammogram technologist to know if a real mammogram was done. This way, if there was some other factor in the mammogram room that caused breast cancer, like the paint on the wall, that increased the risk of breast cancer, the exposure would be the same. Blinding can also prevent investigator bias. For example, if an investigator was truly convinced that there was a benefit to treatment, they would be less likely to allow someone with a family history of breast cancer to go into the control group and not receive treatment.
So the above study would have to run ten years to provide mammograms for the women from age 40 to 49, and to provide no mammograms for the control group. Then data will need to continue to be collected throughout every participants life to see if there was a benefit. Were tumors found sooner? Smaller? Once the diagnosis was made was the treatment for breast cancer easier? More effective? How many had recurrences? Were recurrences local, or were the recurrences to other organs like the lungs, liver, brain or bone? Did patients live longer in the screened group? The main question is, did fewer women in the screened group die of breast cancer?
Unfortunately, Compromise is Necessary
It might take 50 or 60 years to get the final results, and it would be very expensive to run this test. As a result, this type of testing, even though ideal, is never done. Often, new treatment protocols are unblinded early for ethical reasons. A separate group of investigators may be asked to review the unblinded results. This prevents bad treatments from doing more harm, and prevents good treatments from being withheld from the control group.
It is very important to keep the above principles in mind when reviewing data. Unblinded results can be dangerous if the investigator has a bias. Recent developments in the vaccine and autism controversy come to mind. It is important to remember that risk is always relative. Risks that occur often, but cause small problems may be acceptable. A cream that causes temporary burning, but clears a rash is acceptable. Even terrible consequences may be acceptable if they are very rare. An antibiotic that clears a particularly difficult and dangerous infection 99% of the time, but can lead to liver failure and death in 1 in a million treated with it, would be acceptable if they had a better chance of dying without the antibiotic.
Medicine and the Evening News
The evening news is not the best place to get medical information. While many reports are fair, most are sensationalized. Increased drama equals increased viewership, and that leads to more advertising dollars. The motivation to inform is in all reporters and producers, but if the story is not interesting, it will never air.
So in 2011, doctors are still recommending screening mammograms, beginning at age 40. For women with a family history of breast cancer developing at a young age, earlier screening may be recommended. The study by the American College of Radiology (ACR), is much more thoughtful, and certainly more objective, than the US Preventative Service Task Force (USPSTF) recommendations. But you won’t see the same prime time news coverage tonight for the ACR paper that we did in 2009 when the USPSTF made their announcement. The results are not as … interesting.
Yesterday, the FDA released a White Paper and Advisory Statement on Anaplastic Large Cell Lymphoma (ALCL) in women with breast implants. It is important that all patients and plastic surgeons understand the current state of knowledge surrounding this condition.
What Are My Chances of Getting ALCL if I Get Breast Implants?
This condition is incredibly rare. In fact, the known ALCL cases are too few to say conclusively that breast implants cause the disease. Efforts over the past 25 years by all the worlds major plastic surgery societies to raise awareness among members and to identify patients with ALCL have identified 34 unique cases worldwide among an estimated 10 million+ implanted devices. That’s about 1 in 300,000. To put this in perspective: the chance that you will get hit by lightning at some time during your lifetime is 1 in 6250. The chances are the same of you knowing 50 people who have been hit by lightning or one person with breast implant associated ALCL. On the other hand, the chance a developing a “real” breast cancer is 1 in 9.
So it’s Rare … but What if it Happens to Me?
As opposed to the systemic, nodal pattern of ALCL, in published reports, ALCL seen in the presence of breast implants has demonstrated an indolent course. In other words, it doesn’t spread. The women who developed ALCL, were cured with treatment. While ALCL seen in the presence of breast implants does fulfill the current WHO classification for ALCL, a form of Non-Hodgkins Lymphoma, the type of ALCL associated with breast implants potentially represents a distinct clinical entity. This condition is clearly NOT breast cancer.
Because of the extreme rarity of this condition, at this point no standard treatment has been determined. ALCL has been treated with everything from simple explantation (removal of the breast implant) and capsulectomy (removal of the scar around the breast implant) to aggressive systemic therapy. With either treatment, the condition was resolved.
Where Does the FDA Stand?
The FDA has not changed the status or availability of breast implants and has reaffirmed that the devices are safe and effective. In order to better understand this rare condition, the FDA has entered into an agreement with the American Society of Plastic Surgeons (ASPS) to create a registry for ALCL cases in the presence of breast implants. Until this registry is up and running, any clinical case will be reported directly to FDA. The FDA documents provide instructions for how to report any clinical cases to FDA. The American Society for Aesthetic Plastic Surgery fully supports the FDA and ASPS in this endeavor.
It’s Rare … But What Should I Look For?
Despite what you may have heard on the nightly news, the vast majority of breast implant patients will never have this problem. Moreover, most plastic surgeons will never see a single case in a lifetime of practice. The occurrence of ALCL with implants is so rare that routine screening of asymptomatic patients is not indicated; however, we all need to know what signs to look for.
The Presentation of ALCL with Breast Implants
This unusual tumor presents in two main ways:
A collection of fluid (a seroma) that develops well after breast implant placement
A mass involving the scar around a breast implant (the capsule)
Non specific findings: pain, lumps, swelling, or asymmetry, have also been associated with the above findings, and some cases have been associated with capsular contracture (firmness of the breast). If you think there is a problem, contact your Board Certified Plastic Surgeon today for follow-up.
ALCL Does Not Act Like Breast Cancer and There is More Good News
Knowledge is power. Raising awareness should be empowering and not frightening. Recent news reports on ALCL and breast implants seem a bit overblown; however, they do serve as a reminder that all women, with and without breast implants, need to be concerned about breast health. While ALCL is unlikely, the incidence of breast cancer is one in nine, and the vast majority of women who develop breast cancer do not have a family history of the disease.
The good news it that breast health is being discussed openly. I encourage you to do monthly breast exams, and to obtain routine mammography. The sooner a breast cancer is found, the easier it is to treat, and the better the quality of the life saved. Routine screening may seem a bother, but the life you save, will be yours to enjoy.
The ASAPS, the ASPS and Board Certified Plastic Surgeons around the world are all working together on this and other issues to keep cosmetic plastic surgery safe and predictable for everyone. For more information on ALCL and breast implants follow these links:
