Evidently, this is not the first time the company has had problems with the government agency.

• In April 2011 the FDA discovered the drug company marketing the cream without FDA approval.
• Seven months later, in November 2011, The FDA warned Crescendo Therapeutics, they could not continue to market HybriSil as ‘safe and effective’.
• On January 3, 2012, Crescendo submitted an application to the FDA to market HybriSil for investigational use only.
• However, another inspection in January 20l2 revealed that Crescendo continued to distribute HybriSil for non-investigational purposes.

Patients should discontinue use of HybriSil

As of yet, the FDA has not received any reports of adverse reactions from the drug. If you happen to be a patient who is using HybriSil, you should discontinue use immediately. Dr. Dan Del Vecchio, a board certified plastic surgeon in says, “there are alternative drugs on the market that are FDA approved and work well on scars and skin disorders.”   Another board certified plastic surgeon from Dallas, William P. Adams Jr MD, adds “The  scientifically proven scar therapy products are silicone gel sheets and topical silicone gels.  It is unfortunate that  this company chose to promote an non-FDA approved  product to surgeons as well as recommended primary use of a steroid for scar therapy, a practice that few  would agree with.”  For more information on approved topical scar therapy gels containing steroid see a recent PSC mediawire from March 2012.

How does the consumer know if a drug is safe?

Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs says “The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval.”

Dr. Peter Fodor, a board certified plastic surgeon in Beverly Hills says, “It is best for patients, considering today’s ease of gathering information to do some research.  As a source they can talk to pharmacists, check the internet and of course, talk to the physician who prescribed or suggested it.”

“The best way to feel assured if a drug is safe is to have it prescribed by a physician you trust,” says Del Vecchio. He says another benchmark would be to see how long the drug has been on the market and a third way is to look on-line to see if the FDA has issued any warning letters that are related to the drug.

The FDA advises the public and physicians to report any problems from the drug by calling 800-FDA-1088, or by logging on to: www.fda.gov/medwatch/report.htm.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

By Carolynn Grimes
ThePlasticSurgeryChannel.com

Dr. Baxter says there are real benefits for patients:

1. Less reliance on narcotic drugs for pain
2. Less pain in the most critical first three days following surgery

Dr. Brett Snyder, a board certified plastic surgeon says, besides long lasting pain relief, Exparel means an increase in the patient’s comfort and better outcomes. Snyder, a board member of ThePlasticSurgeryChannel.com says, “Using a topical, sustained release local anesthetic will reduce post-operative pain and therefore reduce post-operative narcotics, which will lead to quicker and better results.”

Exparel Receives FDA Approval

Developed by Pacira Pharmaceuticals, Inc., Exparel was approved in October, 2011 by the Food and Drug Administration and recently launched into the market place.  President and CEO of Pacira Pharmaceuticals, Inc., Dave Stack says, “This FDA approval is an important milestone for Pacira, as well as the millions of patients undergoing surgical procedures in the U.S. each year. We are excited to launch Exparel in the United States.”

Dr. Dan Del Vecchio, a board certified plastic surgeon and member of ThePlasticSurgeryChannel.com says Exparel combines Liposome, which is used to deliver chemotherapy and Marcaine which is commonly injected into surgical wounds to reduce pain. “For the past 20-30 years we haven’t made many advantages in post-operative pain management. We treat our patients mostly with narcotics,” says Del Vecchio.  He says, “The problem with narcotics is they can cause side effects.  In young patients narcotics may cause nausea or vomiting, in elderly patients they can cause urinary retention and respiratory depression.” Del Vecchio says, when you look at hospital stays for patients who have received narcotics and have had an adverse side effect, the average increase in a patient’s hospital cost is about 5-thousand dollars.   He says, “not only is it patient safety issue, it’s an economic issue.”

Exparel, a Good Pain Management Option for Plastic Surgery Patients

For plastic surgery patients, Del Vecchio says, “There’s obviously potential to look at our breast augmentation patients, and abdominoplasty patients, these are the patients that have significant pain in the post-operative period.” Controlling pain after surgery is a serious consideration for many people looking into any plastic surgery procedure. Dr. Baxter states, “I think this is a real advantage for patients; if I were going into surgery the idea of not having to experience the pain at least to the same degree would be a very appealing concept.”

By Brett Snyder, MD
and Carolynn Grimes
ThePlasticSurgeryChannel.com

What is a Facelift?

Snyder says, “When we talk about the face, we are generally talking about the area from the chin to the eyebrows. Facelifts as we generally think of them don’t address this area. The traditional facelift is probably better termed lower face and neck lift, because those are the areas that benefit most from the operation.”

Procedures that correct the eyebrows, eyelids and cheeks are usually separate from the traditional facelift procedure and they have their own names such as brow lift and mid facelift. Snyder keeps the terminology simple for his patients and tries to be very specific when explaining how each procedure will help.

Who Would Benefit From a Facelift?

The American Society of Aesthetic Plastic Surgeons (ASAPS), says most patients who are interested in a facelift feel their facial features do not reflect their youthful spirit and energy level. They’re looking for ways to refresh and rejuvenate their appearance.

If you’re seeing signs of aging in your face and would like to do something about it, a facelift might be for you. A facelift can correct some of these common signs of aging…

• Sagging in the middle and lower face
• Creases below the lower eyelids
• Creases along the nose extending to the corner of the mouth
• Look of jowls in the lower face
• Excess skin under the chin and jaw

Dr. Snyder says the lower face and neck lift will improve the appearance of the lower cheeks and jowls, the jawline and the neck. “This will also help the hanging bands in the middle part of the neck,” says Snyder.

However, many people don’t understand why they have to do a facelift if they are just worried about their neck. Snyder says patients are anxious about the facelift portion because they don’t want to turn out like the bad examples they see in magazines. He says, “The neck and the face are connected, they share many of the same structures, and if you’re going to take care of one, then you must also address the other.”

Most importantly, Snyder says, all facelifts are not the same, and a well done facelift will achieve the patient’s goal of a natural, well-rested look with a youthful appearance.

By Robert Grant, MD
and Carolynn Grimes
ThePlasticSurgeryChannel.com

Grant, a leading plastic surgeon in New York says the use of neurotoxins for improvement of facial appearance in the recommended doses has a safety profile and a track record of success that is unparalleled in the aesthetic world.  “When used judiciously, the use of neurotoxins like Botox and Dysport have been a great advance in improving how one looks and feels about themselves,” says Grant.

However, the opposite is true, Grant says, when human growth hormones (HGH) injections are used for cosmetic reasons.  Grant says growth hormones have not been proven safe over the long-term, and without a track record of reliability, he doesn’t recommend their use for cosmetic reasons. “There’s a reason human growth hormones are condemned when used cosmetically by just about every reputable endocrinologist who has studied its use,” says Grant.

What is HGH?

HGH is a hormone that is naturally produced in the pituitary gland in the brain. It stimulates growth, cell reproduction and regeneration, but normally declines after adolescence.  Currently the Food and Drug Administration (FDA) does not endorse the use of HGH as a form of anti-aging treatments. Some of the possible side effects of HGH include:

• high blood pressure
• heart failure
• diabetes
• abnormal bone growth
• hardening of the arteries
• joint/muscle pain or arthritis-like symptoms

If you are someone who is interested in staying younger looking, you are probably better off sticking with the tried and true. Botox has been around for more than two decades and studies indicate that it is safe for cosmetic treatments. Now, there are other brands of neurotoxins on the market that give consumers more choices, including Dysport and Xeomin.

A Healthy Sex Life Increases HGH Production

Grant says if you are still interested in human growth hormones for keeping yourself young looking, he has an alternative suggestion; have more sex! Grant says a recent study from Scotland reports that having a healthy sex life, meaning making love with your partner on average three times a week, can make you look as much as seven years younger. In addition to promoting self-esteem and confidence, sexual activity increases the production of human growth hormone.  Grant says, “There really is no better exercise for the mind and body than a healthy sex life.”

By Lee Thornton MD
and Carolynn Grimes
ThePlasticSurgeryChannel.com

Body contouring around the waistline is very predictable and successful as long as the proper procedure or combination of procedures is selected and tailored to your particular body shape. Dr. Lee Thornton a board certified plastic surgeon says there is some confusion as to when you may need liposuction versus more invasive surgeries such as a mini or a full abdominoplasty.

Thornton says the first step for either procedure is to evaluate the structures that determine the shape in the midsection, from the lower part of the rib cage to just below the waistline. These include the position and condition of the abdominal muscles, and the amount and distribution of the fat in the area. Also the condition, and the amount and quality of the overlying skin is taken into consideration.

When Liposuction May Be Right For You

Thornton says if you happen to have strong muscles that have not been affected by pregnancy, previous surgery or other factors, and the overlying skin is relatively tight with good elasticity, you probably will only need liposuction to get rid of unwanted fat.

When performed in a properly selected patient, Thornton says liposuction is a very safe and reliable procedure. “Liposuction performed by an experienced surgeon will remove unwanted fat, but you must have good muscle tone and the overlying skin must have the ability to tighten after the fat is removed,” says Thornton.

When a Tummy Tuck (Abdominoplasty) May Be Right For You

When there is a significant issue with laxity of the underlying muscles or a significant excess of skin or stretch marks, Thornton says tummy tuck otherwise known as adominoplasty, is probably the way to go.

Mini-Adominoplasty vs. a Full Adominoplasty

A mini adominoplasty takes care of the muscle, skin and fat from the belly button to the pubic area. A full abdonimoplasty addresses the muscle, skin and fat from the rib cage to the pubic area. “If there is a laxity of these muscles you must open the area in order to reshape and tighten the muscular ‘foundation’ of the midsection,” explains Thornton. He says if there is excessive loose skin or skin that has lost its elasticity due to aging or stretch marks, it is essential to surgically remove the skin to achieve the desired result.

Your surgeon may choose to use liposuction or direct surgical removal of fat tissue when performing either of these procedures.  Failure to properly evaluate and address these structures will lead to poor outcomes.  However, when you have a complete evaluation by a board certified plastic surgeon who has experience in this area, you should expect to achieve good and long lasting results.

By Dr. Lee Thornton
and Carolynn Grimes
ThePlasticSurgeryChannel.com

For many women, when they lose weight or stop breast feeding, the skin does not shrink back to its original shape. If you would like to re-gain your original breast tissue but aren’t sure which procedure would be best, Dr. Thornton sorts out the differences and explains some of the most common questions women are asking.

How to choose?

It requires the evaluation and expertise of a board certified plastic surgeon with experience in all of those procedures to achieve the best result.

What are breast implants designed to do?

Implants add volume or size to the breast and they can also change the shape of the breast.  Implants can make the breast fuller, by giving it a more rounded appearance, as well as adding fullness to the upper portion of the breast. Losing volume or fullness is a common complaint of many women that comes with age or pregnancy.

Implants come in different sizes and shapes.

Implants come in different sizes and shapes and can be filled with saline or silicone gel. A plastic surgeon can help you choose the right fill and shape of an implant to correct differences in shapes and size of the breast.  In fact, says Thornton, “Most women have some degree of asymmetry naturally.  He says, “If the asymmetry of the breasts are not too great and the breast does not have too much sagging, drooping or excess skin, a breast augmentation alone will be all that is needed.”

Choosing an Implant that’s too big, could mean complications later.

Choices get more complicated Thornton says, when the differences in breast size or shape cannot be corrected with an implant alone.  He says, don’t  pick a breast implant that is too large for your body.  “ The use of an implant that is too large will lead to problems requiring more complications in the future,” says Thornton. Implants, as a general rule, do not keep the breast from sagging and can often make sagging worse when the breast ends up too large for your body.

Some women have enough breast tissue and don’t need an implant

If you already have a breast size that is adequate, you and your surgeon should give serious consideration to performing a breast lift alone.  Thornton says, “There is no way to add an implant to your breast for fullness and not also increase the size of your breast.”

What is a breast lift?

A breast lift, otherwise known as a mastopexy can give long lasting and natural results without the need for an implant.  The mastopexy alone does not give quite the fullness above the nipple long term that you can get with an implant, however the trade off of the lift alone without the implant is often the best choice when your breast is already big enough.

What the experts say…

In Thornton’s experience, he says in most situations it’s not appropriate to remove your natural breast tissue and place an implant to get that “implant” look or fullness up top.  If you have enough beast size naturally, use your own tissue and just have a breast lift.  “I have often seen patients after they have had a combination lift and implants and they feel they are too big and then they begin to sag again,” says Thornton. He says, “The heavier the breast, the more it droops, regardless if there is an implant or not. Implants, as a general rule, do not keep the breast from sagging and can often make sagging worse when the breast ends up too large for your body.”

To summarize, breast implants are normally used for increasing breast size and for relatively minor shape changes, while a breast lift is sometimes needed with an implant to overcome greater amounts of excess skin or sagging and can be used alone to correct sagging when breast size is already adequate.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

Dr. Robert Grant, a board certified plastic surgeon from New York says, “Everyone has a different healing time because of skin type, genetics and overall health.” According to Grant, “Surgeons should take an individual approach with each patient.”

Dr. Lee Thornton agrees and says, educating patients on the steps outlined below and following your doctors instructions to the letter may be the most important thing you can do to prevent scarring.

Five Steps to Better Looking Scars

Step one - minimize tension on the scar and keep pressure over the scar with surgical dressings. Stress on your incision by lifting or bending can put tension on the incision. The stress can pull the scar apart and delay your healing time, sometimes making the scar wider.

Step two – keep your scar clean to prevent infection. It’s important to identify the signs of infection early and visit your doctor immediately. Signs of infection may include, redness surrounding the scar, swelling or inflammation, drainage, or fever.

Step three – make sure your scar stays out of the sun. Minimal exposure to sunlight is extremely important. Sunscreen is an important ingredient to add for those scars on the face and body that may be exposed to the sun.

Step four – this is where the patient can make the biggest difference. Keep the scar hydrated with topical silicone gel or silicone sheets. Silicone has a proven scientific benefits for healing scars.

Step five – monitor your scar closely. You may need a steroid cream or a steroid injection to cut down on inflammation to prevent widening of the scar or a raised red scar.

New Scar Creams Make it Easier for the Patient

Plastic surgeons with The Plastic Surgery Channel say manufacturers are making it easier than ever for the patients by combining sunscreens and steroids with silicone gels and creams. By combining key ingredients into one product, surgeons say patient’s are more successful at treating their scars because there is one less step they have to take.

Dr. John Gross, a board certified plastic surgeon in California says patients with a history of poor healing that typically get keloid or hypertrophic scars may need to get steroid injections. However, Gross points out, the first line of treatment is to use a silicone gel or silicone with a steroid cream included in the gel. He says, if that doesn’t do the trick to reduce inflammation and redness, then a steroid injection may be needed.

Surgeons agree, by taking these five steps and following your doctors orders, patients can expect a much better outcome for their scars.

By Dr. Brian Reagan
and Carolynn Grimes
ThePlasticSurgeryChannel.com

Don’t Be Fooled By Clever Marketing

Reagan says many ads and infomercials such as the mini-facelift use clever marketing techniques and consumers need to know the difference.  “We are talking about your face, and you can’t simply throw away a bad purchase and buy another,” says Reagan.

Dr. Reagan who specializes in facial rejuvenation at his San Diego, California practice is passionate about plastic surgery advertising and has put together a list of Do’s and Don’ts to help consumers figure out what’s marketing hype and what’s credible information.

The Don’ts:

Don’t believe everything you see in commercials— Many ads claim they use techniques that are new and revolutionary.  Reagan says, most often these claims are not true.  He says, the ‘mini-face lift’ is simply a facelift along with a neck lift under local anesthesia while you sit in a chair.  He explains, the ‘quick lift’ is a type of facelift that uses a stitch or two to lift your face in a more vertical direction.  While this means less surgery and less time for the surgeon, the scars are often longer and placed in a more visible spot.

Don’t be swayed by a fancy procedure name.  Sometimes, it’s just that, a fancy marketing name.

Don’t let the price be the determining factor on which doctor you choose to perform your surgery.

Don’t be pressured into paying immediately to reserve your spot.  If you feel pressured, something is not right and you should leave.

Don’t agree to a surgical procedure without consulting with other board certified plastic surgeons. It doesn’t hurt to get a second or even a third opinion.  Make sure they are board certified in their field of practice and members of the American Society of Aesthetic Plastic Surgeons (ASAPS).  A plastic surgeon who is a member of ASAPS has a particular focus on cosmetic surgery.

The Do’s:

Do your homework.  Look into the credentials of your plastic surgeon. Reagan says, “As surgeons, we know the most important decision you will make is who you choose to do your surgery.”  While many doctors claim themselves as cosmetic surgeons, know that a board certified plastic surgeon has done extensive training to develop the skills and judgment to perform your surgery correctly.

Do understand the limitations of a mini-facelift. Many times the mini-facelift is not sufficient for some patients.  If a doctor only performs the mini-facelift, then he is not capable of giving you an honest consultation on what you may need.

Do ask to talk to previous patients.  If the doctor performs great service, his or her patients should be happy to talk.

With any plastic surgery procedure, make sure the doctor you choose is board certified and that you feel comfortable with the consultation.  A board certified plastic surgeon should be able to offer options based on your particular needs to get the best results possible.

Breast Implant Size and Type in Breast Augmentation

Scientific studies have shown breast implants that are picked to “fit” that the patient’s breast have the least chance of subsequent re-operation and long-term issues.  The final size can be selected by proven tissue based planning principles that include specific measurements of your  breast.   Dr. Adams details  that the 3  main measurements that your surgeon should take to do tissue based planning and implant selection is:

1. Breast width
2. Nipple-fold
3. Skin stretch

Types of Breast Implants

There are three main types of implants used here in the United States.  These include:

1. saline implants
2. round silicone gel implants and
3. cohesive gel implants

Saline implants and round silicone gel implants are FDA approved devices (Allergan, Mentor and just  recently Sientra).  Cohesive gel implants are currently under FDA clinical trials here in the United States and are all shaped devices.  There is no perfect implant.  It is important for patients to understand that implant choice should be based on different factors that will be addressed during the consultation.  The way the  breast implants is uses is the most important factor to consider.  No breast implant can replace  good  decisions and surgical technique.   Following what is called the process of breast augmentation is the single most important principle to get an ideal outcome.

William P. Adams Jr. MD is in private plastic surgery practice in Dallas, Tx, and an Associate Clinical Professor of Plastic Surgery at UT Southwestern Medical Center.

Dr. Adams is a international authority on breast augmentation/ enlargement, breast implants including cohesive gel implants procedures. He has developed a new techniques for use in clinical breast implant surgery that has made breast augmentation / enlargement and breast reconstruction safer for patients.

He also is active in educating plastic surgeons around the country on the new level of breast augmentation currently possible including a re-defined patient experience and fast-trak 24 hour recovery. For more information on Dallas, Tx breast implant specialist – Dr. Adams see more on The Plastic Surgery Channel.

By Carolynn Grimes
ThePlasticSurgeryChannel.com

Plastic surgeons with ThePlasticSurgeryChannel.com recently gathered to discuss the best options for minimizing scars following surgery. Among the panelists, board certified plastic surgeons, Dr. Lee Thornton, Dr. Robert Grant, Dr. John Gross, along with Dr. Bill Adams, president of The Plastic Surgery Channel. During their roundtable discussion each surgeon discussed the latest breakthroughs and the most effective ways to treat and heal scars.

Dr. John Gross a plastic surgeon from Pasadena, California says, “Getting the best outcome and appearance for the patient starts in the operating room.”   He says, “There are lots of ways to proceed with scar healing after surgery.” The first way to proceed is through patient education, says Dr. Lee Thornton, a plastic surgeon who practices in Meridian, Mississippi.  Thornton says, “Our job as surgeons is to try and minimize the scar as much as possible.”

Patient Compliance is Critical for Proper Scar Healing

The Doctors agree, patient compliance is critical for any scar to heal quickly . Dr. Robert Grant from New York City says, there are various factors that come into play. He says, “Time of year, location of the scar, whether the patient is a child or adult, and whether the surgery was done for reconstructive or cosmetic purposes, are all determining factors for scar treatment.” Grant says each patient’s scar should be taken on an individual basis so their goals and objectives are met effectively.

Proven Methods for Healing Scars

There are numerous proven methods for healing and treating scars. Surgeons say usually after a week or two the scar should be ready for either a silicone gel or silicone adhesive. According to each plastic surgeon, silicone is a proven and effective treatment in minimizing the appearance of scars.

Another important measure is avoiding contact with the sun. Dr. Gross says there are silicone products with a sunscreen built in that are easily applied in a gel form. Having two products in one is much easier for the patient to stick with the treatment over the long term.

When asked by Dr. Adams what each plastic surgeon does in their own practices, Dr. Thornton says silicone sheeting along with compression were the two biggest factors.  He says, “The real difference comes when you have a patient who is known to have a poor history in scar healing.”  Thornton says in some cases steroid injections at the time of surgery and after surgery may be necessary. Dr. Grant says, “After about a month I’ll know if the patient is having any problems with thickening, redness, or  itching. If that’s the case, we get into the more advanced regimens of using a steroid or steroid injection.”

For the patient with a history of bad scars, there is also a new product on the market, just approved by the F-D-A that combines a topical silicone gel with a topical steroid.  Thornton says, steroids should not be the first line of therapy when treating scars. He says most scars will heal just fine in the first few weeks. However, sometimes due to genetics, some people are going to heal differently and have poor healing scars.

ThePlasticSurgery Channel.com’s surgeons say, if a scar is starting to show symptoms of thickening, itching, or redness, a steroid injection or topical steroid is acceptable.  However, Thornton says it’s important to keep in mind that while the steroid cuts down on the inflammation of the scar, too much can cause the scar to weaken, thin and widen.  He says, “I use a steroid for a week at most, then re-assess.”

Thornton says, “With new products on the market that combine sunscreen and steroids with the silicone, patients have an easier time caring for their scar.”  He says, “If the patient has to apply two or three different products, that’s hard for anyone to do. I think what we’re seeing now are products that may help with patient compliance.” Surgeons agree, patient compliance above everything else is the number one way to have better healing scars.