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/>

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.

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.

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.