What will be  happening at the  breast augmentation symposium?

Dr. Adams and his team will be bringing one of their own patients from Dallas to Atlanta for a live surgical demonstration in breast augmentation.  Dr. Adams says that he is very excited about attending the prestigious meeting and looking forward to educating surgeons on the next level of expertise in breast augmentation procedures.  Recently there has been news reports of breast augmentation procedures carrying a greater than 25% re-operation or re-surgery rate.  Dr. Adams states that this is a misnomer when breast augmentation is practiced with the advanced techniques; the same techniques he will be educating the Atlanta Breast Symposium attendees about this weekend.  “Using the Process of Breast Augmentation,” he says, “our scientific publications have demonstrated a re-operation rate of less than 3% and optimized patient outcomes.

Viewers interested in breast augmentation information should stay tuned to The Plastic Surgery Channel for upcoming programming and information.

Viewers should stay tuned for reports and live patient interview’s at the Atlanta Breast Symposium in the operating room and following surgery.  The Plastic Surgery Channel will attend and bring you the experience of the patient providing first hand experience during the breast augmentation procedure.

What are Gummy Bear Breast Implants?

Lots of patients ask her about the difference between different cohesive breast implants and whether all silicone breast implants are cohesive.

Silicone breast implants made a comeback into the American market in 2006 and since then there has been confusion about the two types of implants – the traditional round gel implants and the newer form stable implants. This brings us to the question as to whether all silicone implants are cohesive and what exactly are Gummy Bear Implants. While all silicone implants are cohesive to some degree, there is a difference between the round silicone breast implants that are currently approved and the newer form stable devices that are still considered to be under investigation in this country.

Are Gummy Bear implants really different?

Gummy Bear Implants also called  cohesive gel implants fall within the newest form stable device category which means that they are just stable enough to resist folds and creases but soft enough to feel like a breast. They are considered to be semi firm but pliant nevertheless. The form stable feature refers to the fact that they are expected to retain their shape in every position. So there should be minimal creases, rippling or overlapping when a patient sits, stands or lies down.  In the US, Gummy Bear Implants are always shaped implants.

Dr. Glicksman advises that is a doctor suggests a Gummy Bear Implant, the patient should ask if they would be required to participate in a long term study. The reason for this is that Gummy Bear Implants or Cohesive Gel implants are not approved by the FDA in the United States and the authority requires a long term, large scale study to be conducted under rigorous guidelines before it can approve the same. Until then, these devices can only be made available to patients within the context of such a study. She further suggests doing ones due diligence and homework while considering a breast implant. Choosing a Board certified plastic surgeon is important and the patient should remember to ask the right questions including the exact type of breast implants the surgeon suggests as  well as  there expertise in the procedure including  presentations and publications they have done on breast augmentation.

Dr. Glicksman is a Medical Board Advisory Member of the Plastic Surgery Channel and  an  expert on gummy bear breast implants.

What are the the 3 S’s of Breast Augmentation

Most patients are confused by the myriad of options available these days and the information available on the internet only increases such confusion. Dr Snyder practicing in Jacksonville says that breast augmentation can be simplified into the three S’s – Silicone vs. Saline, Surgical approach & Size:

• Silicone vs. Saline is usually the very first choice that customers have to make while undergoing a breast augmentation surgery. Silicone generally has a more natural feel and need to be monitored periodically and potentially replaced. Saline implants on the other hand, are perfectly fine but there exists the risk of their rupturing and this happens at a very low rate. In some patients with minimal overlying soft tissue envelope, saline implants might not be the best option due to rippling and un-natural feel.
• Surgical approach for breast augmentation, in Dr. Synder’s practice is determined by the type of implant used. For most silicone implants, the approach of choice is to go in through the crease underneath the breast. Other options for silicone include the border of the areola and in the armpit. For saline implants he prefers the endoscopic approach through the armpit as this usually leaves a very small, inconspicuous scar. The downside of this approach is that the incision is not adequate for most silicone implants.
• Size is probably one of the most important decisions that a surgeon and their patients can make together. Size can be approached in two different ways. The first approach is to examine the patient’s breast and chest and look at the soft tissues of the breast itself. Using objective criteria, the surgeon will usually make a suggestion as to the best sized breast implants given the goals of the patients. Another approach is to have patients try on implants in a bra. While this is not a perfect approach, it does give the surgeon and the patient an idea as to what they are looking for in terms of size and what might suit them the best in terms of body proportion.

Does the 3 S’s of Breast Augmentation Work?

Keeping in the mind the three S’s should help patients simplify the process of breast augmentation before seeing a surgeon and make the best choice for themselves.
Breast augmentation specialist Dr Brett Synder is a Board certified plastic surgeon practicing in Jacksonville, Florida.

This is one of the most controversial and confusing topics from a patients standpoint. Most patients have heard different things from friends and from physicians about the placement of breast implants. He clarifies that there are three ways to place a breast implant:   Subpectoral, Subglandular and Subfacial.

There is really no one correct way to place a breast implant and each type of placement has its own benefits and is more suited to some patients. There are some patients who benefit from placing the implant under the muscle, at other times, unde rthe  breast or under the pectoralis fascia may be an option.

There are other aspects that must be factored in when deciding where to place the implant. The most important thing is to have a surgeon that takes the time to do a complete evaluation taking into consideration the size and shape of the original breasts, the size and shape of the desired breast, how much soft and subcutaneous tissue there is above the implant once it is placed, whether the implant is gel or saline, smooth or textured. All of these things have a part to play in the decision process.

Dr. Thornton dispels the myth that mammograms are much easier to read when implants are placed under the muscle. He clarifies that more and more evidence is becoming available that in the absence of scarring around the implant, or what is called a capsule contracture, mammograms are equally easy to read whether the implant is placed under the muscle or under the breast.

As a member of The American Society of Plastic Surgeons and The American Society for Aesthetic Plastic Surgery, Dr. Bruce W. Van Natta,M.D. has expertise in a variety of cosmetic and reconstructive plastic surgery procedures.

Recently an article in the Orange County Register titled “Breast Implants lead to return visits to the OR” started a discussion about the life of breast implants. According to the article, about one third of breast implant patients, i.e roughly 33% have a follow up operation within 4 years. Dr. Van Natta corrects this number saying that the actual figure is around 23.5% which is almost 10% lower than the reported number. 23.5% is still admittedly a high number but it is much lower than what it has been made out to be.

The other controversial discussion in the article was about the fact that breast implants need to be changed/ replaced or removed after 10-15 years. This has certainly not been the case that Dr. Van Natta has observed in his practice. He does caution that breast implants are most certainly not “forever devices”. As with any other device that is inserted into the human body such as knee replacements and pacemakers, the device wears out with age and if the patient lives long enough, the device would need replacement. The breast implants functions in pretty much the same way and may need replacement if the patient lives long enough. However, there is absolutely no restriction of 10-15 years on the life of breast implants

PSC Breast  Co-chair Dr. Caroline Glicksman Overviews the important patient message of the FDA press release

Key points for patients include:

1.  ALCL of the breast is an extremely rare illness and should not be confused with breast cancer.  Much more data is needed to make any clear statement, but the FDA does not recommend that patients with breast implants do anything differently, and this report had no bearing on the FDA position that breast implants are safe and effective.

2. To date no epidemiological study has shown a cause and effect relationship between ALCL and breast implants.

3. The risk of ALCL in patients with breast implants is exceedingly low – .05 – 1: 1 million person years.  Thus a woman with breast implants is 10 -200 times more likely to be hit by lightning than to contract ALCL.

4. Despite years of research, the worldwide data on this subject is very limited.  In fact, in the few cases that have been identified, the actual pathological diagnosis did not always follow all protocols to make the diagnosis of a true Lymphoma.  This coupled with the observation that the identified cases all behave inconsistently,some with characteristics of a more benign process.  Many of the reported cases resolved with implant removal or no treatment in some cases.   More data is needed but the entity may represent a pathological misdiagnosis of a lymphoid hyperplasia.  There is also growing data to suggest that this entity is more like the benign cutaneous T cell lymphoma (a form of lymphoid hyperplasia) that has a typically indolent course.

The  American Society of Aesthetic Plastic Surgery released this to physicians :

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 plastic surgeons understand the current state of knowledge surrounding this condition and are prepared to discuss this with their patients.

This condition is incredibly rare – in the past 25 years only 34 cases have been reported worldwide among an estimated 10 million+ implanted devices.  In addition, 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: both with women experiencing aggressive systemic therapy as well as those treated with simple explantation and capsulectomy – the condition was resolved.  While this condition does fulfill the current WHO classification for ALCL, a form of Non-Hodgkins Lymphoma, this condition potentially represents a distinct clinical entity.  This condition is clearly NOT breast cancer.

The FDA has not changed the status or availability of breast implants and has reaffirmed that the devices are safe and effective.  However, in order to better understand this rare condition, the FDA has entered into an agreement with ASPS to create a registry for ALCL cases in the presence of breast implants.  Until this registry is up and running, any clinical case should be reported to FDA.  The FDA documents, which can be found at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm provide instructions for how to report any clinical cases to FDA.  ASAPS fully supports the FDA and ASPS in this endeavor.

Because of the extreme rarity of this condition, the vast majority of plastic surgeons will never see a single case in a lifetime of practice.  However, if you have a patient who presents with symptoms such as a delayed seroma after implant placement or a mass involving a capsule you should be aware of this rare differential diagnosis.  The FDA White Paper contains suggestions for evaluation, if ALCL is suspected.  Because of the extreme rarity of this condition, at this point no standard treatment has been determined.

The American Society of Plastic Surgeons released this:

Today the Food and Drug Administration (FDA) issued a communication to inform health care practitioners and the public about a possible association between breast implants and anaplastic large cell lymphoma (ALCL). Although ALCL is extremely rare, the FDA believes that women with breast implants may have a very small but increased risk of developing the condition. ASPS has been actively engaged with the FDA on this matter. The American Society of Plastic Surgery is collaborating with the Agency to develop a centralized registry to collect more information on existing case reports and any new cases that may be identified going forward.

The Agency has posted two resources on its website. The first is a Safety Communication that provides a summary of the issue, recommended actions for physicians and patients, and how to report information to the FDA. The second is a more detailed report of the FDA’s preliminary findings and analyses on ALCL in women with breast implants.

Following the signing of a Confidential Disclosure Agreement with the Agency, ASPS was asked by the FDA to comment on both documents. Working with both internal and outside scientific experts, ASPS provided extensive comments, some of which are reflected in the final documents.

The FDA has provided the following links to their documents:

FDA Medical Device Safety Communication: Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings & Analyses

The FDA has issued a press release and is conducting a media conference call and stakeholder call today.

Other reports in the media on this  subject:

From Healthcare Channel TV:

Some things you need to know about this breast implant “cancer” scare.

• The FDA official behind it is Dr. Maisel who is brand new on the job. His background is as a Beth Israel electrophysiologist who has been very critical of medical device safety. However, after joining the FDA late last year, the new GOP congress has caused the FDA to back away from ICD safety. Now, he is going after breast implants.
• The diagnosis of lymphoma is not a black or white 100% certain diagnosis. It is a judgment call. The FDA report lays out many inconsistencies with this type of ALCL “lymphoma” and the type normally found. It is quite likely that these T-cells were just part of the normal chronic foreign body reaction.
• All of the cases recovered completely when the implants were removed, again supporting that this is not even cancer.
• Even if the cases were real lymphoma, the statistics are nowhere near confidence. They are collecting more data in a registry now.

Given the past scares in breast implants that were eventually debunked, this is very inappropriate for the FDA to do at this point in the data collection.

Awake breast augmentation has  never been shown to  have  any advantage over modern breast augmentation techniques.  In fact, the  best patient outcomes have been proven in peer reviewed studies that includes a short general anesthetic for the surgical procedure.

Finding a reputable plastic surgeon, according to the Los Angeles Times is more than just reading up some advertisements and business listings. The newspaper on June 16, 2010 wrote about the care that patients must exercise while choosing a plastic surgeon and things they must be aware of while doing the same.

Unfortunately these days doctors with insufficient training are becoming more popular simply due to their ability to advertise and promote themselves better in the electronic and print media. On the other hand, plastic surgeons who devote their time to getting better training and certifications and improving their skills do not typically promote themselves with marketing tactics.

The LA Times article suggests a lot of things one must keep in mind while selecting a surgeon one of them being that patients should choose surgeons who are board certified. Dr. Fodor, however, cautions patients that they must be careful about being impressed by board certifications. It is important to ensure that the plastic surgeon is be certified by a board that is legitimate as nowadays there are a lot of boards and certifying authorities that have sprung up which do not have much authority. The board must be recognized by the American Board of Medical Specialties and must not be a self created board.

One thing that patients should look out for is that their plastic surgeon should be a member of the American Society of Plastic Surgeons ASPS, American Society of Aesthetic Plastic Surgery  ASAPS . If a surgeon belongs to either of these societies  they are  board certified and have  passed that hurdle.

The article also talks about forming a personal opinion about the plastic surgeon when one meets them directly at the time of the consultation. One issue we see with this article is it recommends that the patients should try and look for a “free” consultation from the plastic surgeon to discuss the various aspects of the surgery. Dr. Fodor disagrees with this notion that consultations with plastic surgeons should be free as the consultation itself should be a long and detailed process. In his practice, Dr. Fodor easily spends an hour in consultation with each patient. Surgeon who are well trained and at the top of their field generally charge for their time.  In many cases it is a red flag to   see “free consultations” advertised.   Most well respected and well trained plastic surgeons would charge somewhere in the vicinity of $200 for a consultation. This gives doctors an opportunity to devote their time to those patients who are actually serious about getting a plastic surgery procedure done. While, this is not an exorbitant amount, it allows a surgeon to devote time to his consultations which is an extremely important pre operative process. These consultations allow a surgeon to lay out the benefits and potential threats from the surgeries, to understand the patient’s motivation to go in for the surgery and also set expectations straight.