What patients should know about breast augmentation in New Jersey

Many women who are considering a breast augmentation in New Jersey begin their search on line and may be confused by the choices of implants that are available today.  Since 2006 both saline filled and silicone filled breast implants have been available to women in the United States.  In general, implant choices include both saline and silicone devices.  But there are also other choices to consider.  Silicone implants are manufactured as both round and shaped devises and they may have either a smooth or textured surface. So first let’s discuss the fill of an implant.  Although saline implants were popular for a really long time, many women and their plastic surgeons were unhappy with the feel of the implants and the rippling that could be felt or seen. They are still an option for many patients, but silicone gel implants are now the most popular implants in most of the world.

What is important for patients to know about implants for breast augmentation?

Silicone Gel implants for breast augmentation can be further divided into two groups:

• First there are the round gel implants. These implants are made slightly underfilled to make them soft and the gel is more cohesive, slightly thicker, than it was in earlier generations implants.  They come with both a smooth and textured surface on the outer shell of the implant, as texturing of the surface was thought to reduce capsular contracture, a tightening of the pocket around the implant.  There are many studies underway to determine if texturing of implants makes a real difference, but for now we do know that texturing may help with maintaining the position of an implant
• The newest generation of Form Stable Highly Cohesive Gel breast implants are nicknamed the “Gummy Bear” implants.  They are also called the Style 410 Silicone gel implant. These implants remain investigational in the United States until their FDA approval.  Gummy bear implants are very different from the round gel implants.  First of all the gel is thicker, or form stable.  This makes the implants just firm enough to resist folds and creases, yet soft enough to still feel like a breast.

Studies over the last 10 years in the US and since 1993 in Europe have shown considerably lower rupture and capsular contracture rates, however, studies are still ongoing until these implants are FDA approved. Finally, many web sites and plastic surgeons are creating “cohesion confusion” and women are often mislead by practices and sites advertising for “gummies” or “highly cohesive implants” that are just round gel devices.  Keep in mind the following when learning about your implant choices:

• Round silicone gel breast implants were FDA approved in 2006 after a 15 year moratorium.  They come with both a smooth and textured surface and should be available at all plastic surgeons’ offices.
• The newest generation of highly cohesive form stable implants, also known as “Gummy Bears” are always shaped, and always textured.  Patients must enroll in a FDA approved clinical trial, agree to a long-term 10 year follow-up, and these implants are only available from plastic surgeons who are approved investigators.

Dr Glicksman has been in practice for 20 years in New Jersey. Breast augmentation is a primary area of  expertise for her and she  has  presented nationally and internationally on this subject as well as published peer reviewed articles on breast augmentation. Remember a better educated breast augmentation New Jersey patient will make safer decisions and achieve longer lasting results.

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.

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.

Recently there was an article in American Health and Beauty about Stem Cell Facelift. The news about stem cell research and its uses has become more and more popular and recently its publicity has gained more momentum as it has become known that the body’s fat tissues are a very rich source of adult stem cells. These stem cells show a lot of potential as they are harvested from one’s own body and may be used to treat a variety of diseases at some point in the future.

Dr. Peter Rubin is a renowned plastic surgeon who is a specialist in plastic and reconstructive surgery. He is also at the forefront of cutting edge research in the field of tissue reconstruction and its application to plastic surgery. Dr. Rubin has been at the forefront of the research on stem cells.

However, even though the technology is promising, there is a limitation as to what these cells can do and achieve. More importantly there are safety concerns and government regulations in place and which will be put in place to regulate the usage of these stem cells. Dr. Rubin cautions that while this is a technology which may have far reaching impact, at this point of time, there is not a single FDA approved use for this technology in aesthetic treatments or procedures in the US.  There are also a number of devices that are available internationally to  harvest and produce stem cells, yet none of these are approved in the US as of this post.

Dr. Rubin predicts that stem cell technology will most likely play a very important role in aesthetic surgery and procedures in the future. He advises that there must be careful and cautious steps taken towards the implementation of this technology. For this proper research and studies will have to be carried out and researchers and surgeons will have to work alongside the FDA to ensure that the safety measures are in place so as to achieve the best results possible.

Patients should be aware that terms such as  “stem cell facelift” are  marketing terms and not based in science at this time.  Hopefully with  god  research in the future the  use of  stem cells in facelifts may be  able to be defined.

The Fraxel ReStore Dual laser  is an FDA approved laser treatment that was introduced 5-6 years ago that revolutionized the use of laser energy or wavelengths for skin treatments. This treatment produces targeted treatment zones in the skin which allows the remaining area to be unaffected. The specific wavelengths when delivered to the skin create a desired smoothing effect on wrinkles, pigmentation, acne scars. The new fraxel technology divides the lasers into individual zones of heat so that instead of blanketing the skin with the light and injuring the skin, only a specific area can be treated. These individualized treatment zones can now be seen as pixels on a television screen and depending on the density of the zones that it was administered to, about 20-25% of the area of the skin will be covered.

Dr. Forley is a board certified plastic surgeon who specializes in aesthetic facial, breast and body contouring surgery. He has been in private practice in Manhattan since 1994. He brings a plastic surgeon’s aesthetic judgment and understanding of anatomy and aging to the use of the Fraxel Re:store Dual Laser Treatment.

With the new fraxel restore dual laser technology, there are two wavelengths – a deeper penetrating wavelength, the Erbium fiber which is the 1550 wavelength which targets the deep layer of collagen and treats wrinkles, texturing of the skin, pores etc. There is also a superficial Thulium fiber wavelength, the 1927 wavelength which is very effective for pigmentations and helps relieve signs of aging due to exposure to sun and other brown pigmentation.

The benefit of having both wavelengths available on the same fraxel restore dual laser device is that both treatments can occur easily and different concerns can be addressed at the same time. The wavelengths can be mixed and matched to provide a desired effect to the patient.

The fraxel laser treatments show short term redness and swelling which lasts for a few days, but there is no visible wound from the treatment. Usually about 4 treatments which are spaced two to four weeks apart produce are required to achieve the desired results with the non ablative laser which means that the treatment reaches the inner layers of the skin without harming the outer layer.

Non-Invasive ‘Cold’ TechnologyZeltiq is a company developing a new, non-invasive technique for improving the body contour called “Cryolipolysisâ„¢”. Currently the device is only FDA-approved in the U.S. for skin cooling and anesthetic uses, however is used in Europe and Canada for fat reduction. The technique employs cold to reduce fat cells thereby enhancing the shape of the body. It is based on work originally done by Dr. Rox Anderson’s group at Wellman Labs. The device is currently undergoing rigorous clinical trials to produce quantifiable data prior to commercial launch.

How It Works

The cells in our body react to heat or cold at different temperatures levels. The research performed by Zeltiq has helped us better understand what these levels are so we can achieve body contouring through fat reduction. It works by pressing the device against the area to be treated and then becoming cold enough to target only the fat cells in that area. The body reacts with an inflammatory response which causes the body to naturally dispose of the damaged fat cells. By doing so we see a significant improvement in the shape of the body. The Zeltiq Procedure is performed in a doctor’s office, typically under the supervision of a dermatologist or plastic surgeon. There is no anesthesia needed or recovery time. During the procedure, tissue is drawn into a cup with mild vacuum pressure. Patients may also be slightly uncomfortable with the contact of the cold as the procedure begins, which usually goes away after the first 10 minutes or so. If you feel too uncomfortable with the cold, let your doctor know. After the treatment is completed, patients may immediately return to their normal activities including work and exercise.

Several days after the procedure, the cooled fat cells begin a process called “apoptosis” and begin to shrink. These damaged fat cells are slowly digested over several months by our bodies and removed through the liver. The procedure is highly effective and is producing consistent results for local areas of fat like the love-handles or ‘man-boobs’, though larger areas of fat may require more invasive treatments.

The best candidate for Zeltiq is someone who is in relatively good shape, but has modest areas of fat bulges that they’d like removed. It’s not an alternative to healthy diet or lifestyle.

Possible Side EffectsSide effects are usually mild and related to the cold of the device which subside within 10 minutes. Skin may be red for several minutes to several hours, if this persists for more than that you should contact your doctor. Other side effects may include temporary bruising, tingling, tenderness, temporary dulling of sensation or cramping.

ADDRESS:
2164 Highway 35
Building A
Sea Girt, New Jersey 08750-1013
EMAIL: docglicksman@aol.com
PHONE: 732-974-2424 FAX: 732-974-0134
WEB: http://www.drglicksman.com

As a member of The American Society for Plastic Surgery, Caroline Glicksman,MD has expertise in a variety of cosmetic and reconstructive plastic surgery procedures.

Dr. Caroline Glicksman is a board-certified plastic surgeon with offices in Sea Girt and Red Bank, New Jersey since 1991. She received a BS in Microbiology and a BA in Sociology from the University of Massachusetts, in Amherst, Massachusetts. Dr. Glicksman went on to attend The State University of New York, Downstate Medical Center, receiving her MD in 1985. She did her general surgery training at the Mount Sinai Hospital in NYC and completed her plastic surgery residency at New York Hospital-Cornell Medical Center and Memorial Sloan-Kettering Hospital in 1991. Dr. Glicksman then completed a cosmetic surgery fellowship at the Massachusetts General Hospital, in Boston.

Soon after starting her own private practice in New Jersey in 1992 she became active in the fight to mandate insurance coverage for breast reconstruction. She also played a role in the silicone breast implant controversy. In 2003 and again, two years later, Dr. Glicksman testified before the FDA Advisory Panel on Silicone Breast Implants. She is credited with bringing more patients to testify on behalf of silicone safety than any other physician in the country. In 2005 she represented both the American Society of Plastic Surgeons (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS) before members of Congress as a member of the National Breast Implant Task Force.
Since 1995 Dr. Glicksman has been an investigator in the FDA adjunct studies of silicone and saline implants. A decade later she became one of a handful of surgeons sent to Sweden for extensive training in the use of the form stable, highly cohesive breast implants: the newest generation of silicone gel devices. She is now enrolling patients interested in these devices for breast augmentation, reconstruction, and revision surgeries.

Dr. Glickman’s published works include articles in the Journal of Plastic and Reconstructive Surgery on breast implant imaging and the management of implant complications. Recently she completed a chapter on the management of breast implant complications for a new text on breast augmentation, and has another chapter on Patient Education in Breast Augmentation, in progress. She is presently on the Allergan Academy faculty, and a member of the Allergan Executive Council on Breast Aesthetics. A mother of four, Dr. Glicksman is married to an orthopedic surgeon.

ADDRESS:
50 E. 71st Street
New York, New York 10021
EMAIL: drwalden@theplasticsurgerychannel.com
PHONE: 212-288-9009 FAX: 212-288-9007
WEB: http://www.drjenniferwalden.com

As a member of The American Society of Plastic Surgeons and The American Society for Aesthetic Plastic Surgery, Jennifer L. Walden,MD, FACS has expertise in a variety of cosmetic and reconstructive plastic surgery procedures.

A regular in the media, Dr. Jennifer Walden is a sought-after source on topics such as technological advances in surgery, soft tissue injectables, mommy makeovers, celebrity plastic surgery, breast implants, and general medical correspondence. She is a regular guest on national news outlets such as Fox News Channel and has been featured on E! TV’s 20 Best and Worst Celebrity Plastic Surgery Stories, ABC’s 20/20 on silicone breast implants, as well as CBS’ The Early Show regarding the FDA release of silicone breast implants for general use. Her comments have also appeared in Vogue, Cosmopolitan, Absolute Magazine, Bridal Guide, Dallas/Fort Worth’s Indulge, and The New York Sun.

Dr. Walden is a Board Certified Plastic Surgeon by the American Board of Plastic Surgery and is formally fellowship-trained in Cosmetic Surgery. She is currently an Attending in Plastic Surgery at Manhattan Eye, Ear and Throat and Lenox Hill Hospitals, and has the academic appointment of Clinical Instructor of Surgery (Plastic Surgery) at New York University Langone Medical Center. She is also a member of the prestigious American Society of Plastic Surgeons, American Society for Aesthetic Plastic Surgery, and is a Fellow of the American College of Surgeons. As one of a very small number of board-certified female plastic surgeons in New York City formally fellowship-trained in cosmetic surgery, Dr. Walden is very interested in women’s health issues as they relate to plastic surgery and breast health.

In addition to her skills in plastic surgery, Dr. Walden is also an established author, having published numerous articles and presented multiple award-winning research papers as well as co-authoring a textbook entitled Aesthetic Plastic Surgery which was released this spring by Elsevier. She also serves as a consultant to the nation’s leading breast implant and aesthetic companies including Allergan Medical, and serves on their National Council of Leaders in Breast Aesthetics. She is a co-investigator in the Silicone Breast Implant Clinical Adjunct Studies as well as the Breast Implant Follow-up and Post-Approval Studies.

The FDA has approved a new dermal filler that contains enough lidocaine to provide nearly instantaneous numbing for patients getting facial wrinkles and folds filled.

“Before the introduction of Juvederm XC, it often took up to 30 minutes for an anesthetic block to take effect,” clinical investigator Dr. Charles Boyd said in a press statement. The product has a similar safety profile as its predecessor, Juvederm, a gel hyaluronic acid dermal filler manufactured by Allergan.

The smooth consistency of the Juvederm gel makes it easier to inject and reportedly provides more natural looking results that last for up to a year. Injectable fillers provide a safe, non-surgical option for women and men who want to smooth facial wrinkles and folds without surgery, such as a brow lift or lower face lift.

The new formulation, Juvederm XC, maintains the same results as its predecessor and also contains a small amount of lidocaine, which numbs the treatment area within seconds, making the cosmetic treatment a more comfortable experience for the patient. The lidocaine is also intended to reduce or eliminate the need for any additional anesthetic.

The results during a double blind test were promising: 93 percent of patients reported less pain when treated with the new formulation of Juvederm compared to those treated with the non-lidocaine formulation.

Juvederm XC is now available nationwide; however, just like other dermal fillers, it should be administered by a trained medical professional.

The “LipoVibe” technique is a form of custom acoustics liposuction (CAL), also called nutational infrasonic liposuction. It requires less exertion from a surgeon during the procedure and removes adipose tissue through a heat-free system of vibration and rotation, causing less trauma to the surrounding, non-fatty tissues. The system also allows the removed fat to survive so that it can be used in future fat transfers. And, because the technique’s “nutational,” or spinning, vibration system activates nerves that do not transmit painful signals, the procedure results in  less bruising and discomfort to patients.

Although invented more than 40 years ago, liposuction technology has made tremendous leaps forward in recent years. Currently available methods include ultrasonic-assisted liposuction, “Vaser” (laser-assisted) liposuction, radio frequency liposuction and a water-assisted procedure. They all slightly differ in their techniques, but generally produce less bruising, swelling and soreness and offer a quicker recovery time than the traditional cannula method.

South Texas plastic surgeon Dr. Thomas Jeneby is one to vouch for the CAL procedure, saying he likes what it does for the patient, and for him.

“I am amazed by how much less physical effort on my part this new innovative form of liposuction takes,” Jeneby said. “The nutational 3-D mechanism of action enables me to glide through the fibrous fatty tissue more easily and is ideal for those patients who’ve had prior surgeries or scar tissue. My patients have a faster post-op recovery, less bruising and less pain. In fact, some of my patients say the 3-D vibration sensation from the cannula actually tickles them and they start laughing during the procedure.”

The CAL technique currently has approval from the Food and Drug Administration and already has been tested in public, at scientific forums. Reportedly it has been employed in more than 7,000 procedures since its worldwide introduction in 1997, though its use is new in the United States.