By Carolynn Grimes
ThePlasticSurgeryChannel.com

Plastic Surgeons from ThePlasticSurgeryChannel.com react to the arrest today of the faulty French breast implant founder. Claude Mas, the 72-year-old head of PIP was taken into custody this morning at his home in the south of France. Mas has been charged with deceptive business practices and fraud and now faces a potential charge of manslaughter after a French women with the PIP implants died of cancer.

Texas based, board certified plastic surgeon, Dr. Bill Adams, says fortunately, the implants were never approved here in the United States.

According to Adams there are stricter regulations here in the U.S., involving health and the products that are used in health care. The PIP scandal has caused a huge health scare among thousands of women across Europe and South America. PIP was shut down last year in March 2010 after it was discovered that the company was using industrial grade silicone in their breast implants instead of medical grade silicone that is used here in the U.S.

“The silicone implants that are presently used in the United States are manufactured by Allergan, Mentor and Silimed/Sientra (FDA clinical trials only), and must all meet the strict requirements of our Food and Drug Administration (FDA)” says Board certified plastic surgeon, Dr. Caroline Glicksman from New Jersey.

It’s been reported the faulty implants have a high percentage rate of rupturing among many of the women who had the implants inserted. It’s estimated that 300,000 women in 65 countries received breast implants from the company.  PIP exported 80 percent of its products, many of them to Britain, Spain and Latin America, causing worry and confusion for women all over the globe wondering if they too have the implants.

Dr. Adams says if a woman from the U.S traveled to another country for breast augmentation options, she could have received these defective implants. Adams, who specializes in breast augmentation, says “if you’re going across the world or going to other places that don’t have certain regulations, you could run into problems.”  See PSC Mediawire on Medical Tourism for more information.

Currently Over 2,000 French women have filed legal complaints against PIP and their complaints will be investigated case by case.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

It’s a serious question to consider because many women find after having surgery they wished they had gone either a little bigger or smaller.

Dr. John Gross, a board certified plastic surgeon from Pasadena, California, says the size and type of breast implant you choose should be a decision made between you and your surgeon based on the patients size and existing breast tissue.

Fortunately, says Gross, “the options for breast augmentation and the devices (implants) available have markedly improved over the last decade.”  According to Dr. Gross, there are currently two implants approved by the Food and Drug Administration (FDA) which include saline and silicone filled implants both with a silicone outer envelopes.

Gross points out, that there’s a third implant available not yet approved by the FDA, but may be a great option for some patients.

It’s a highly cohesive gel that’s called style 410, referred to as the Gummy Bear implant. “Where it may have particular advantages is with patients who are very thin in their breast tissue, yet want a very natural result,” says Gross.  “Because of its shape and the fact that it tends not to wrinkle or ripple as much as some of the other devices, it may be a great option” says Gross.

Gross says when explaining the decision making process to patients, you’ll hear him frequently use the word, trade-offs.  He says, “all the choices whether they are saline filled, traditional silicone gel filled or the style 410 gummy bear, they each have different benefits.”

According to Gross you should carefully consider your options following a thorough examination and consultation with a board certified surgeon.  Dr. Gross say’s he encourages all his patients to take as much time as they need to think it over.  “When the patient has had time to absorb the information, discuss options with a friend or family member and come to a solid resolution they feel more comfortable moving forward.” He also supplies his patients with detailed information and encourages them to check out his web-site to help answer all their questions.

By: Carolynn Grimes
ThePlasticSurgeryChannel.com

Unapproved and potentially dangerous breast implants sold overseas stir debate over the safety and risks associated with aesthetic plastic surgery.

According to the author Alexander Edmonds, the recent scandal involving unapproved and potential dangerous breast implants sold by a French manufacturer should raise questions about the safety and risks surrounding all aesthetic surgery.  Edmonds received a PhD in anthropology from Princeton and has written on the social dimensions of plastic surgery.  He is the author of “Pretty Modern: Beauty, Sex and Plastic Surgery in Brazil,” and is assistant professor of anthropology at the University of Amsterdam. Edmonds says, “With most surgeries, the risks are weighed against expected health improvements. But aesthetic procedures, by definition, do not improve health.”

Dr. Jeffery Kenkel, President of the American Society of Aesthetic Plastic Surgery (ASAPS) disagrees. “What would be next? Will physicians be banned from performing procedures on cleft lip children because it doesn’t prevent or cure disease?”

According to reports, the recent breast implant scandal could affect up to 300 thousand women world wide.  The French manufacturer, Poly Implants Protheses (PIP) has admitted to authorities it was producing and distributing breast implants with a cheaper industrial grade silicone instead of a medical grade silicone which could be harmful according to officials. The implants have also shown to have a high rate of rupture. Edmonds says, “The fact that a surgeon is putting in implants sends a subtle message that they are safe.”

Edmonds points out that one response to the PIP scandal is a ban on doctors performing cosmetic breast augmentation altogether. He says, “It’s well known that breast implants of many types can cause burning pain, loss of sensation, hardening of breast tissue and serious infection.”     Breast implant expert, scientist and  Vice President of  The Aesthetic Society Education and Research Foundation (ASERF) ,  William P. Adams, Jr, MD says he  does not  agree with this conclusion,  “it  appears he is  quoting the  exceptions and not the rule, in fact the science and data says when implants are used with modern techniques that outcomes are optimized, patients have very few issues and have  an extremely high degree of satisfaction.”

The FDA says both saline and silicone breast implants in the U.S. are safe.

He quotes the FDA’s 2011 ‘Update on the safety of silicone gel-filled breast implants’, which states that: “Frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others.” But Kenkel says, “That’s not true.”  Last year the FDA (Food and Drug Administration) concluded that the silicone-gel implants are safe as long as women understand they come with complications.  According to Kenkel, “Breast implants are one of the most studied medical devices in the history of the FDA. Both saline and silicone implants that are manufactured in the U.S. are safe.”

However, Edmonds says the FDA made clear that local complications are not uncommon. He quotes the FDA’s 2011 ‘Update on the safety of silicone gel-filled breast implants’, which states that: “Frequent complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection, among others.”

Kenkel says Edmonds is confusing the issue of an unethical manufacturer using non-medical grade silicone and the legitimacy of plastic surgery. “When surgery involves a medical device that was fraudulently manufactured, it’s more logical to question the manufacturer than question the patient’s motivation for wanting the surgery.”

Dr. Leo McCafferty, President Elect for ASAPS says, “Cosmetic Surgery, if performed by a board certified plastic surgeon in a properly licensed and accredited facility has never been more safe.”   Dr.  Adams  agrees. He says, “If we look at the benefits of cosmetic and plastic surgery procedures to patients, it’s very well documented that patients have incredible elevation of their quality of life, and there’s data to support that.”

From 2009-2010, there was almost a 9% increase in the total number of cosmetic surgical procedures, with over 1.6 million surgical procedures this year, according to ASAPS. It is also reported that the number of breast augmentations alone have tripled during that same time frame with a 90% plus satisfaction rate.

Edmonds says his goal in the piece was to add to the already extensive debate about the risks of cosmetic procedures and whether consumers are adequately informed about them.  Drs. Kenkel and Adams , both Board Certified Plastic Surgeons in Dallas, Texas,  agree that patients need to be more educated on procedures and say patient education by qualified Board Certified Plastic Surgeons is a top priority in their practices.  In the end, they say,  an informed and educated plastic surgery patient results in a better outcome for the patient.

McCafferty states that anyone considering plastic surgery should “seek properly trained Plastic Surgeons certified by the American Board of Plastic Surgery and members of ASAPS and ASPS (American Society Plastic Surgeons). These surgeons operate in accredited, licensed facilities using safe effective FDA approved products, devices, implants and equipment.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

What causes the breast and other areas to sag?

It’s estimated 200,000 people underwent gastric bypasses and gastric bindings in the United States last year. Many of those patients were left to deal with excess skin and tissue following their extreme weight loss.

ThePlasticSurgeryChannel’s Dr. Peter Rubin is the director of the Life After Weight Loss program, a clinical center at the University of Pittsburgh. He is also the lead author of the body contouring medical textbook for plastic surgeons, Aesthetic Surgery After Massive Weight Loss (Elsevier Medical Publishing, 2006). According to Dr. Rubin, plastic surgery after weight loss is the fastest growing area of plastic surgery.

Dr. Rubin and his staff have developed a new procedure in body contouring to help reshape the breast.

According to Dr. Rubin, “We see very dramatic changes in the breast after weight loss, including loss of natural breast volume and a very troubling bra roll that can form.”  Dr. Rubin says “Using the patient’s own tissue we create an internal brassiere that better supports the new shape of the breast.” Additionally, tissue from the side of the chest is used to both increase breast size and eliminate extra skin alongside it.

Rubin says, “This procedure can be very effective in achieving dramatic changes and positive results for our patients. However, it’s more extensive than a traditional breast reshaping procedure and can involve longer scars.” Dr. Rubin says the procedure is a new field in plastic surgery and may not be for everyone. Patients should always discuss their options with a board certified plastic surgeon.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

William P. Adams, Jr. MD, a board certified plastic surgeon from Dallas, Texas will conduct what a  refined breast augmentation technique that includes fast-track 24 hour recovery.

The surgery demonstration is taking place in Atlanta, Georgia at the 28th Annual Breast Symposium.  The purpose of the surgery is to teach his colleagues a precise way of doing a breast augmentation that leaves the patient with less trauma, relatively no downtime and a very natural looking result. Adams says, “This teaching demonstration will show how to refine the procedure and improve patient outcomes.”

The patient involved in the surgery is Cari Murray, a 35 year-old Texas mom who says she can’t wait to see her body restored back to the way she used to look before children.

Murray says, “I chose Adams not only because of his fast track 24 hour recovery, but also because of his professional demeanor during our consultation.” Murray says what appealed to her was the open communication and being able to determine exactly what she wanted in her breast surgery. She’s looking for a natural looking breast that fits her frame without being too big or too small.

As she waits for the surgery, Murray seems optimistic and upbeat, eager to see her new self.  It’s typical for Adam’s patients to either go back to work, go shopping, or just go through their normal activities on the same day of the procedure, without narcotics.

Tune in tomorrow to ThePlasticSurgeryChannel.com to see the actual surgery procedure taking place and the outcome for Murray as she goes from surgery to recovery.

By Caroline Glicksman, MD
ThePlasticSurgeryChannel.com

The French breast Implant Crisis Escalates

Last year, the French based company PIP (Poly Implant Prothèse) had their implants banned because it was discovered that they were utilizing a non-medical grade silicone as the filler for their gel implants.

In addition, the recent reported death of a French woman from the rare form of cancer ALCL, who had PIP breast implants has led to a tremendous amount of media concern about a company recognized by few American women.  Inspections in France as early as 2001 had revealed numerous non-conformities surrounding the manufacture of PIP implants. In 2009, it was reported that there were high rupture rates with their implants in France, leading to allegations of implant shell problems. In 2010 distribution was suspended and the company filed for bankruptcy.

PIP appears to have used two types of silicone gel within their breast implants; the “Medical Grade” silicone manufactured by Nusil, (made in US and France), and a less expensive formula that they claimed was chemically identical. When implant manufacturers describe their silicone gel, they often uses terms such as “Industrial Grade”, “Medical Grade”, “Health Care Grade” and even “Implant Grade.” These terms can differ around the world.  There are multiple tests for silicones including mechanical, chemical, animal, biochemical, cell culture tests and clinical evaluations that are required to determine what silicone formulations are safe for long term human implantation.1 Summing it up, “Medical Grade” silicones are those that have passed extensive, strict biological testing, and in the United States the manufacturers must formally submit their data to the FDA for approval.

The fallout from the French Breast Implant Crisis discovery has left women worldwide confused and worried.

It appears that various European and South American Health Ministry’s are offering different options to women who have these devices.  While France is offering to pay for the removal and replacement of PIP implants used in breast reconstruction, Venezuela will pay for explantation only. Other European nations, such as the Netherlands, Ireland, Austria, and Denmark, to name a few, are suggesting only close follow-up of women who have these devices. Each health ministry, as well as the FDA, has repeated their conclusion on breast implants that although there may be a very low but increased risk of developing ALCL adjacent to breast implants, with less than 70 cases reported in the world literature to date, these represent a very small fraction of the 5-10 million women who have received breast implants worldwide. In addition, PIP implants have not played a significant role in the US market since the company’s 2000 request to market saline implants in the US was denied. The silicone implants that are presently used in the United States are manufactured by Allergan, Mentor and Silimed/Sientra, and must all meet the strict requirements of our FDA.

Finally, as with all silicone gel breast implants, there is no exact expiration date. No implant will last a life-time, and all silicone implants, regardless of their manufacturer, should be followed and imaged as they age.

1 Allistar Winn, Manufacturing and FDA Compliance Support, date accessed 12-29-11, date modified October 10, 2011. <http://www.appliedsilicone.com/selecting-the-proper-grade-of-silicone-and-test-protocol/>

Plastic Surgery Channel expert Dr. Bruce Van Natta talks about breast lifts / mastopexy in Indianapolis, Indiana.

What exactly is a breast lift/mastopexy?

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

This is a commonly requested procedure that is often misunderstood. Generally when a woman has excess skin around the breast often after pregnancy or weight loss, the breast size has reduced and there is a lot of skin around the area. This can be viewed as a deflation effect in the breast and the treatment for this would be to conduct an operation to remove some of that excess skin. Following pregnancy many women feel that their breast deflate, loose volume and become saggy. Dr Van Natta has been in practice for 20 years in Indianapolis, Indiana. Breast lifts / mastopexy have been one particular area that Dr Van Natta has specialized in his practice.

Who needs a breast lift/ mastopexy?

Dr. Van Natta finds that a lot of times women come in thinking that they need a breast implant or breast lift/ mastopexy when they that would not automatically be the right procedure for them. At times like this, it is important to sit down with the patient and really understand what their goals are in terms of how they want to look and appear without involving names of procedures and technical terms. Sometimes after such consultations, the surgeons can determine that all the patient really wants is a little more fill in the upper part of the breast and this can be achieved easily with an implant. Really taking the time to talk to patients and asking to see before and after pictures can help a surgeon understand what the patient’s goals are and allow them to do the right procedure. Seeking consultation with a board certified plastic surgeon is the 1st important step in patients getting the best outcome with breast lift / mastopexy. Asking questions and also talking to other patients who have use the same surgeon for a breast lift/ mastopexy can be helpful.

When a mastectomy is necessary to save or prolong the life of a cancer patient, the topic of breast reconstruction surgery is often almost as important to the patients as is getting better. In fact, some patients regret delaying reconstruction when it isn’t medically necessary, said survivor Rebecca Larson during her appearance on Plastic Surgery Talk. And while there are several techniques for performing the surgical reconstruction of breasts that have been removed, one of the most common is the use of breast implants.

Breast reconstruction with implants is a safe and effective means of restoring a mastectomy patient to a  traditionally feminine appearance after a mastectomy. And, while it’s true that the results of an implant procedure don’t always have a look and feel identical to what you get from a procedure using living tissue, the implant option requires far less surgery and involves far less risk to the patient. Scarring is reduced, for one thing, and the less-invasive nature of implant surgery often means less pain, reduced chance of infection, and shorter recovery time.

Implant surgery for reconstructive purposes usually involves the use of an appliance called a tissue expander. Its purpose is to make room for the implant under the remaining skin of the breast area. To do this, the surgeon puts the balloon-like expander under the patient’s chest muscle. About fourteen days later, he or she will begin injecting saline solution into the expander through a port under the skin similar to the port used in Lap-Band® weight loss surgery. As it is inflated with saline over time, the expander stretches the tissue to fit the proposed implant; the expander is then deflated and removed, and the silicone gel or saline breast implant is then inserted in the “pocket” created by the expander. The entire procedure, with several saline inflations, takes about two months to complete.

It’s important to know that breast reconstruction with implants isn’t suitable for everybody. The implants don’t last forever, and will probably need to be surgically removed and replaced at some point down the road. The implant procedure also carries the usual risk of complications, including special-case problems like capsular contracture (the formation of scar tissue around the implant causing the breast to display a “hard” look and feel.) And while it’s true that implants can give the mastectomy patient a symmetrical and appropriately-sized chest, there’s no surgery that can duplicate the look and feel of natural breast tissue. Patients considering implant-based breast reconstruction surgery should talk to breast specialists and other survivors so she can approach the procedure with realistic expectations of what the end result will be.

If you’ve had a mastectomy, or if you might require one in the future, consult with your physician, oncologist and a board-certified plastic surgeon as soon as possible regarding your options for breast reconstructive surgery. And it should be noted that this consultation might first require some research. Not all doctors are as credible as their websites make them appear, and many don’t have extensive experience with breast reconstruction.

“Just because a surgeon pops up number one on Google doesn’t necessarily mean they’re the best breast augmentation surgeon,” explained Dr. Jennifer Walden, a New York plastic surgeon. “Patients have to do their due diligence. Just like doctors learn in training, patients need to educate themselves about credentials and board certification.”

Having succeeded in finding one, however, you will probably find that a certified professional can give you the information and support you need. This will help you make the choices that are most appropriate for you.

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Breast reconstruction specialist speaks out

Despite the fact that mastectomy is sometimes the only way to save the life of a person with cancer, the loss of any part of the body can cause psychological trauma and damage to the patient’s self-esteem. This damage also occurs in cases of patients with serious breast deformities, abnormalities, or other defects in the appearance of the breasts.

Fortunately, plastic surgery offers hope to patients recovering from mastectomy or other disfigurement:  breast reconstruction surgery. The surgical reconstruction of lost or disfigured breasts does more than help heal the patient’s physical wounds – it enables them to confidently resume their normal lives.

“To many women, breast reconstruction is a symbol of hope that they can get past this cancer diagnosis,” University of Michigan plastic surgery professor Dr. Amy Alderman told Medical News Today. “Reconstruction is not necessarily the right option for every woman and not everyone is going to choose reconstruction, but I think it’s important that every woman is informed of what the benefits of reconstruction can be for their physical and emotional well being.”

Two forms of breast reconstruction surgery exist: immediate breast reconstruction and delayed breast reconstruction. Immediate breast reconstruction is breast reconstruction that is performed at the same time as the mastectomy. Immediately after the patient’s breast or breasts are removed by a general surgeon, a plastic surgeon begins creating new breasts. The primary advantages of immediate reconstruction are the reduction or elimination of psychological trauma, a lessening of scar tissue and combined recovery time for the two procedures.

The main problem with immediate reconstructive surgery is the possible necessity of future surgeries. Should the patient’s cancer return in a form that requires more surgery, the entire reconstruction could be jeopardized. Another problem arises if the patient needs radiation therapy – the reconstructed tissue could be negatively exposed to radiation as a result. And of course a patient who is one the fast track to surgery for her breast cancer will probably not be given sufficient time to discuss the planned appearance of her reconstructed breasts. This can lead to aesthetic issues later.

Delayed breast reconstruction is performed after the mastectomy itself. Some choose this option for the sake of simplicity – after all, dealing with a cancer diagnosis is stress enough without having plastic surgery options to worry about.  Delayed reconstruction also allows patients to examine her reconstructive surgery choices at length, reducing the risk of dissatisfaction with the size or appearance of the reconstructive work. Finally, delayed reconstruction allows for chemotherapy or radiation treatment to be carried out without damaging reconstructed tissue or risking unplanned changes in the reconstructed breasts.

The reconstructive process itself can take several forms. The most common is the implant procedure. In implant reconstruction, a breast-like “mound” is formed by the surgeon by combining a surgical breast implant (silicone or saline types are both used) with the remaining tissues of the breast. Additional tissues from other parts of the body (e.g. the buttocks) may also be used to add fullness and weight.

Tissue flap reconstruction is another form of breast reconstruction surgery. It may be done in two basic ways:

•    Pedicle Flap: a flap of tissue from the back or belly is pulled under the skin up to the chest area and attached there without cutting its blood supply
•    Free flap: the same, only the tissue and blood vessels are cut and surgically re-connected to blood vessels in the chest area

Nipple reconstruction is another, separate step. This is a difficult task, but one performed successfully in most cases. Although there is a variety of procedures for nipple reconstruction, the most common involve the placement of a plastic tissue expander under the skin of the new breast, which is gradually filled with saline over a period of weeks until the skin is stretched into a nipple shape; a permanent implant can then be implanted. Tissue grafts from a remaining, undamaged nipple, or from some other part of the body, can also be performed. In all cases the color and appearance of the nipple and surrounding area is restored primarily by tattooing.

When considering breast reconstruction surgery, it’s important to remain realistic about outcomes. No surgery can give a woman a new breast; the reconstructed breast may appear natural, but it will lack the natural sensation of a real breast. That being said, skillful breast reconstruction surgery can restore the mastectomy patient’s womanly shape and feel, giving her the confidence and good self-image that can lead to a full recovery and a return to normal life.

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Plastic surgeon Dr. James Namnoum says breast lifts, with or without having a breast augmentation or breast reduction, are a popular procedure with women who have had children.

“These patients are thinking to themselves that they want to recover their breast tissue, they want to have a rejuvenated breast, they want a filled breast mound, they want a more feminine look,” he says. “In addition, they want to overcome the changes they have experienced in their breast and in their body since they’ve carried their children and perhaps breast fed them.”

Often, women have lost volume in the “upper pole” area of the breast – the area between the collarbone and the nipple. Making an aesthetically pleasing adjustment can involve what is called a mastopexy, or breast lift. In this procedure, a surgeon remodels the breast by shaping the glandular tissue, moving the nipple upwards and re-draping the skin.

Namnoum adds that in other cases, most often in America, women want their breasts lifted and made larger at the same time.

“This can be done, but has to be done with an emphasis on safety,” he says, pointing out that keeping blood circulation to the nipple during such procedures is difficult but crucial.

Beyond the operation, women are curious about what kind of scarring to expect. It varies, but Namnoum performs breast procedures that often create scarring around the areola and sometimes underneath the breast mound.  The scars do go away, but not immediately. Over a long period of time, they change color and texture and can appear to get better, then worse. In some cases, steroid injections are necessary when scar tissue gets itchy or irritated.

“I think patients should be thinking in terms of 12 months to two years,” he says about scar fading. “It’s not going to happen overnight.”