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

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/>

Dr. Peter Rubin with Dr. Oz

Using Stem Cells to Re-Grow Breast Tissue

On Friday, December 16, 2011, Dr. Rubin along with Dr. Oz and Suzanne Somers discussed the role stem cells may play in plastic surgery. Dr. Rubin says, “We are optimistic about stem cell based technologies for breast reconstruction, and need to approach the topic cautiously and with great respect for the safety of our patients. These are experimental therapies, and we need to collect data under approved clinical studies to be able to tell if this will be safe and effective.”

On the Dr. Oz Show, Somers opened up about her battle with breast cancer and the stem cell surgery that she says, helped reconstruct her breast. Somers’ procedure is considered to be a minimally invasive method of restoring breast volume using fat moved from another part of the body.

Consumers Should Use Caution

Despite celebrity endorsements, Dr. Rubin says consumers really need to be cautious when considering stem cell therapies. He says, “The biggest problem encountered with fat grafting is that fat can lose volume or be absorbed by the body over time leaving less of an affect from the original treatment.”

As a practicing plastic surgeon and a scientific researcher in stem cells, Rubin says, “There are encouraging data from laboratory and clinical studies to suggest that the use of adult stem cells is a very promising field, but as our comprehensive review of the current scientific literature shows, the data available today do not substantiate the marketing claims being made to patients seeking aesthetic surgery and aesthetic medical treatments.”

Dr. Rubin recently led a special joint task force to research and address concerns over claims and clinical practices using stem cells that have not been substantiated by scientific evidence.  As a medial advisory  board member for the ThePlasticSurgeryChannel.com, Rubin details some of the confusion over stem cells in the following videos:

1. Researchers Explore Stem Cell Facelift
2. Plastic Surgeons Say Do Not Believe the Stem Cell Hype
3. Stem Cell Facelift Pittsburgh, Pennsylvania-Dr.-Rubin

The two leading plastic surgery associations, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS), back up Rubin’s statements saying, “While there is tremendous potential for the future use of stem cells in aesthetic surgical procedures, the scientific evidence and other data are very limited in terms of assessing the safety or efficacy of stem cell therapies in aesthetic medicine.

Rubin wants patients to know that while this technology is promising, it is an experimental treatment and should only be done as part of an approved clinical trial.   He says patients should always see a board certified plastic surgeon for a proper evaluation before considering any stem cell procedure.

About The Plastic Surgery Channel

The Plastic Surgery Channel is a company devoted exclusively to educational programming about cosmetic and reconstructive surgery. Our goal is to provide credible, up-to-date information to people considering plastic surgery or a cosmetic procedure, as well as coverage of the latest news and hot topics from the field of plastic surgery.

Unlike shows you might see on network or cable television, the programming on The Plastic Surgery Channel does not strive to be sensationalist, focusing solely on extreme cases, nor is it solely devoted to a documentary-style overview of various medical procedures. Rather, we strive to inform — and in some cases entertain — viewers by providing relevant, engaging content that covers all facets of cosmetic and reconstructive surgery. We rely on experienced, board certified leaders in the field as content consultants, and conduct substantive research to verify the accuracy of the articles and videos that we present.

Of course, The Plastic Surgery Channel is not meant to replace the advice of medical professionals. Viewers are reminded to always consult a medical professional before making any decisions about plastic surgery or any other form of surgery.

For more information about our programming and our faculty, please email us at info@theplasticsurgerychannel.com

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.

Much of the pain caused by breast augmentation is due to the fact that the body tissue in and around the implant has to have some time to get used to being more cramped. Those who get their implant put under the muscle – also known as a submuscular implant – will be in more pain than those whose implant sits on top of the muscle. This is because the muscle needs time to stretch out over the implant. The process only takes three to four days, but can be very painful for patients, affecting their ability to do everything from pumping gas to washing hair.

Dr. Paul Zwiebel is a practicing plastic surgeon based in Littleton, Colorado, for over 25 years. He has followed approximately 500 patients for the past few years in an attempt to find out if pain pumps can give post-operative patients any additional benefit in their recovery.

A pain pump is a device put in during surgery which delivers a continuous flow of local anesthetic  to the patient during the first few days after surgery. Because the anesthetic is local and not a painkiller, the patient may experience fewer side effects and be able to recover faster. “We have been using the pain pump routinely with breast augmentation and have had some wonderful results,” says Dr. Zwiebel.

What Dr. Zwiebel found is that pain management was dramatically improved for most patients. “The advantage is that the pump is working as a continuous infusion, so there are no peaks and valleys.”

Pain pumps are available on the general market, so patients planning to get breast implants can ask their surgeon about using a pain pump.

Macrolane isn’t available in the U.S. just yet. But, while it waits for FDA approval, thousands of British women – about 3,000 since the filler was approved 18 months ago – have taken advantage of this new, non-surgical way to enhance the body.

“Macrolane is a new, injectable product that’s specifically been developed for body contouring,” says Dr. Christopher Inglefield.

Instead of getting breast or butt implants to correct unevenness, doctors can simply inject the large-scale filler into the area that needs enhancement.

It can also help with issues such as restoring breast volume after childbirth and breastfeeding. It’s also injected under local anesthetic, which means less downtime and quicker recovery than surgical enhancements.

Since the filler will degrade over time, it’s necessary to have a maintenance treatment about every 12 months. “The results of the treatment last about 12 months, so most women will need a top-off treatment around that time,” says Dr. Inglefield. 

Three-dimensional imaging technology uses photos from a single patient at multiple angles to produce a 3-D model of the patient. This model can then be used and manipulated to simulate the effects of different surgical procedures, especially aesthetic ones.

Dr. Paul Zwiebel’s practice in Denver performs about 100 breast augmentations each year, and was one of the first offices to use 3-D imaging technology for breast augmentation patients.  Using the 3-D model has been more effective for these patients because they can now view their own body from an outside perspective with different sized implants. Dr. Zwiebel says this technology has made one of the hardest decisions of breast augmentation a little easier for patients. “What I hear from women is that one of the toughest choices is deciding what’s the right size.”

In the past, patients have been limited to wearing enhancers that simulate the cup size they want, or simply lokoing at other patients’ before and after photos. But, Dr. Zwiebel says 3-D imagining has best helped his patients decide which size implant is most appropriate for their body type.

The patient is photographed at the time of consultation, and then doctor and patient can view the photos together, using the images to simulate various implant sizes. “It makes the choice of the size of implant so much easier,” he says.

Because patients can now see each implant size on their own body–and not someone else’s – patient satisfaction has improved. “Our patient satisfaction is very much improved because there isn’t second guessing,” says Dr. Zwiebel. Video plays below.

Editor’s note: the attached video includes graphic footage of surgery.

For nearly 15 years, saline implants were the only option available to breast augmentation patients until the FDA re-approved silicone implants for cosmetic procedures in 2006. Although patients had limited choices, saline implants not only offered a track record of safety, but also the added benefit of flexibility, since they are not pre-filled.

Because they were deflated during insertion, doctors found they could utilize a variety of new techniques for inserting the implants that resulted in smaller incisions and less scarring. This meant that the scars could be placed in several areas; some more subtle or hidden than others.

Today, those techniques are available for all kind of implants — silicone as well as saline — and it’s important to know what kind of technique your surgeon will use, and the risk and benefit of each.

Inframammary: This incision is made where the breast comes together with the chest wall. A correctly placed incision means the scar is only visible when the patient is lying down.  One advantage to this approach is if the surgeon has to go back in to correct any complications, no other incisions need to be made. The breast tissue, muscle and implant are all accessible from this incision. A disadvantage to this incision site is placement; the surgeon must determine where the new crease will be, not where the old breast fell. Also, if the patient decides to either have the implants removed or go up a size, the old incision will be visible.

Periareolar: This incision is made around the bottom half of the areola. This incision is commonly used in patients receiving a breast augmentation and lift at the same time. It also allows the surgeon to work close to the breast, making placement of the implant easier. The main disadvantage to this type of incision is that muscles and connective tissue must be separated during surgery, and that causes additional discomfort during recovery. Also, since the entry point is so close to the areola, the risk of losing sensation is greater.

Transaxilary: The transaxilary incision leaves no scar on the breast itself but instead in the patient’s underarm. This technique allows for implant placement above or below the muscle, and usually results in fewer breast feeding complications for women who go on to become pregnant. However, this type of incision cannot be used with silicone implants, makes placement more difficult since the surgeon is farther from the breast, and complications have to be addressed with additional incisions, if needed.

With any of these techniques, and with any kind of implant, patients will experience soreness for two to three days as their body gets used to the change. Most patients are able to return to normal activity in a week.