Mentor Corporation Announces FDA Approval of Prevelle Silk: First Dermal Filler to Prove Pain Reduction in the U.S

April 1st, 2008
SANTA BARBARA, Calif., Mar 21, 2008 (BUSINESS WIRE) — Mentor Corporation (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, today announced that the Food and Drug Administration (FDA) has approved Prevelle Silk. This is the first of a new line of lidocaine containing hyaluronic acid (HA) dermal fillers that Mentor anticipates marketing and distributing globally.

Prevelle Silk is a colorless HA gel with lidocaine that is injected into facial skin to reduce moderate to severe facial lines, folds, and wrinkles. The product is the first in a new line of HA dermal fillers that Mentor is developing with Genzyme Corporation (NASDAQ: GENZ). Lidocaine, a local anesthetic, is added to provide pain relief at the site of the injection. In a controlled clinical study, patients experienced significantly less pain during injection with Prevelle Silk when compared to an HA product that did not contain lidocaine.

Mentor Corporation has forged a strategic development partnership with Genzyme Corporation, a global leader in the development and manufacturing of HA products. Mentor Corporation will market and distribute the products globally. “We believe both patients and physicians will be excited to have an effective dermal filler option with lidocaine to help make the filler injection more comfortable,” said Brian Luedtke, Vice President of Global Marketing and Sales of Mentor Corporation. “We believe Prevelle Silk will be an excellent complement to our portfolio of lidocaine containing HA dermal fillers, the second of which is under review with FDA and the third in clinical trial. We will shortly begin targeted launch efforts to experienced dermatology and plastic surgery dermal filler customers and anticipate a broader U.S. commercial launch in combination with our second dermal filler later this year.” About Prevelle Silk PREVELLE SILK is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). In clinical studies, adverse events were usually mild to moderate in nature, did not require intervention and lasted seven days or less. The most common side effects included temporary injection site reactions such as swelling, pain/tenderness, redness, and lumps/bumps.

 

Revitalash….You will have lashes like you have never seen in your life!

April 1st, 2008

Like liquid eyeliner, RevitaLash is simply applied once-a-day to the base of the eyelashes. Within three weeks, the difference can actually be measured! By eight weeks, your own natural eyelashes will look as though they had extensions! These dramatic results are seen in women of all ages! No matter how short, brittle, thin, or sparse your eye lashes are, RevitaLash can help you achieve long, beautiful, healthy eyelashes…Longer, Thicker Fuller eyelashes. RevitaLash is physician formulated and tested, and ophthalmologist safe for eyes. One tube of Revitalash lasts 3-5 months if used only on the upper lashes.

Revitalash was developed by Dr. Michael Brinkenhoff as a gift for his wife who had just completed chemotherapy treatment for breast cancer. As an ophthalmologist, Dr. Brinkenhoff believed he could develop a formula to help his wife’s beautiful eyelashes, destroyed by the harsh chemotherapy, to grow back. After only a few weeks of use, friends and family began to wonder how Mrs. Brinkenhoff’s eyelashes had grown back so full, so quickly. Thus, Revitalash MD LashGro was born, so all women could benefit from Dr. Brinkenhoff’s amazing formula.

You will love this stuff!

The Little Book Of Lipo

April 1st, 2008

The Little Book of Lipo: Everything You Need to Know About Liposuction but Didn't Know to Ask

Teen Dies from Breast Surgery

March 27th, 2008

It was so sad to read about the 18 year old Florida cheerleader who died from complications of a breast augmentation, and my heart goes out to her family and friends. For me, when I hear of a cosmetic surgery ending in tragedy, it’s also a wake up call for patients, and I remind all my clients who are considering surgery, you’ve got to prepare for it…Any surgery is risky, but those risks can be minimized by taking certain crucial steps to safety-proof your surgery. In the case of the West Boca High School cheerleader, they suspect a rare condition triggered by anesthesia.That’s why I warn people, you’ve got to fully disclosing all medications you are taking, including over the counter drugs, herbs, vitamins or any drugs, legal or illegal—that could dangerously interact with anesthesia. We won’t know what happened until the autopsy, but if even if you are taking over the counter cold medicines, tell your surgeon—and the anesthesiologist. People don’t die from actual surgery, but from complications, and it’s as important to choose a top anesthesiologist as it is to choose your plastic surgeon. I’m not blaming, it could happen to any surgeon. It’s a tragedy for everyone,  including the board-certified cosmetic surgeon who performed the operation in a private surgery facility. Here’s what the Miami Herald wrote: “The West Boca High School cheerleader, 18, died Saturday from complications during surgery to correct asymmetrical breasts and inverted nipples, after being rushed to Delray Medical Center Friday morning.

According to her family’s attorney, a rare and silent condition called malignant hyperthermia could have killed the popular teen, who was looking forward to her senior prom and heading to the University of Florida.

The condition is triggered by anesthesia. Symptoms include rapid heart rate, muscles that become rigid and a fever of 110 degrees or higher. The condition is reversible if recognized and acted upon — usually within 30 minutes of onset — with Dantrolene, the only known antidote, said Dr. Henry Rosenberg, president of the Malignant Hyperthermia Association, whose organization fielded a call to its hot line about Kuleba’s case. “

While the autopsy results aren’t back, so we won’t know for sure exactly how she died until then. But I urge you to do your homework before surgery, and outline a number of things you can do to safety proof your operation. While I focus on liposuction in my new book, “The Little Book of Lipo” (Amazon, $19.95), it has pre-surgery tips that can apply to any cosmetic procedure. As a patient, you CAN maximize the chances for a safe, successful surgery.

 

American Society for Aesthetic Plastic Surgery and American Society of Plastic Surgeons Offer Patient Advisory for those Affected by Fig LipoDissolve Closures

January 27th, 2008

New York, NY (December 14, 2007) — Responding to recent reports of the Fig LipoDissolve Centers going into Chapter 11 bankruptcy protection, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) offers the following advice to patients currently in treatment there or suffering from unwanted outcomes. Although neither Society recommends the use of injection lipolysis for fat reduction until appropriate research has documented the safety and efficacy of this non-FDA-approved treatment information is available for those patients needing help.

  • If you are in the middle of lipolysis treatment and have concerns:
    Contact ASAPS

  • If you are in pain, have a complication such as swelling or bleeding or need immediate attention; please contact your nearest hospital emergency room.

  • If you are seeking body contouring or are considering your various options please remember the following:

  All procedures involving injecting pharmaceutical or other agents into the body are medical procedures and need to be conducted in an appropriate medical setting by a physician. A Board Certified Plastic Surgeon can help you weigh your options to achieve the optimal outcome you desire. The ASPS and ASAPS do not recommend that their patients undergo injection lipolysis treatments. All medical procedures have risks. If you decide a procedure is right for you, make sure you have done your homework, that the procedure has been fully explained by your healthcare provider and that you have thoroughly read and signed informed consent documents. “The proliferation of advertising of such treatments and the abrupt closing of Fig LipoDissolve Centers nationwide has raised many questions from both patients considering treatment, and those who have already been injected with the unproven medical treatments touted to reduce localized fat. Said Alan Gold, MD President – elect of the Anesthetic Society, “To date, injection lipolysis, LipoDissolve or any fat-melting injection has not gone through FDA sanctioned clinical trials or the research necessary to document the results claimed or clearly identify the potential underlying complications.” “Consumers should not ignore the proliferation of blogs and media that are reporting the ineffectiveness and the complications experienced by fat-melting injections,” said Richard A. D’Amico, ASPS President.” This mixture is not FDA approved nor has it been formally tested for predictable results or safety. That alone should steer consumers away from the marketing hype.”

New Study Shows Surgical Treatment on Breast Asymmetry Improves Quality of Life

January 27th, 2008
New Study Shows Surgical Treatment on Breast Asymmetry Improves Quality of Life

 

 
New York, NY (December 17, 2007) – Findings from a study released today in the November/December issue of the Aesthetic Surgery Journal suggests that surgical treatment for breast asymmetry (disproportionate breast size) provides an improvement in the quality of life and self-esteem of patients. Breast asymmetry is not uncommon in women; in fact, few women have perfectly symmetrical breasts. “Breast shape and size irregularities can cause damaging physical and emotional consequences,” said Miguel Sabino Neto, MD, PhD, lead author of the study. “While plastic surgery of the breast can provide an aesthetically acceptable result with few complications, it is important to also consider the impact on the physical, social and psychological well-being of the patient.”Thirty-five patients with breast asymmetry were selected for the evaluation of the impact of breast asymmetry surgery on self-esteem and health-related quality of life. Patients that participated in the Brazilian study ranged from ages 16 to 50 years old.Patients completed the Brazilian version of the SF-36, a quality of life indicator that measures eight dimensions of health status, including physical function, role limitations caused by physical problems, pain, health perception, vitality, social function, role limitations caused by emotional problems, and mental health. Participating patients also completed the Rosenberg Self-Esteem Scale, which evaluates quality of life based on responses to ten questions on the subject of self-esteem. Both were completed before and after surgery at three and six months post-operative follow-up.A progressive improvement in all dimensions of the SF-36 was observed, with scores that were significantly higher for emotional factors at three months after surgery and for pain, vitality and mental health six months after surgery. Self-esteem was also found to be statistically significant.“These findings underscore the positive effect that surgical treatment can have on patients with breast asymmetry,” said Foad Nahai, MD, Atlanta plastic surgeon, President of ASAPS and Associate Editor of ASJ. “The results of such surgery go far beyond aesthetics, more importantly improving the self-esteem and quality of life of these patients

  

Kanye’s Mom: Donda West Tragedy and Dr. Jan Adams

November 23rd, 2007

  My question: how was this guy on television for years and no one ever questioned whether he was board certified or not? Dr. Jan Adams, star of Discovery Channel and a pioneer surgery show that hit the screen before Extreme Makeover (Plastic Surgery, Before and After)… Now he’s got troubles, we learn, alleged drinking issues, an array of malpractice suits and serious questions about precautions he took and how closely Donda West was monitored before and after surgery. But we also learn he’s a general surgeon who has reportedly done a residency in plastic surgery and a fellowship in aesthetic surgery. That’s on his website. But my question is why didn’t he take his board exams for plastic surgery? That’s a big red flag…or did he take the boards and failed?? All questions that need to be answered, and harsh reminders why I dig into doctors’ education and work history before they get my Good Houskeeping Seal.  For example, a surgeon has to be board certified, to be a member of the Aesthetic Society, a prestigious group of top cosmetic surgeons for whom surgery is an art and a science…But to even become board certified, the first step to Olympus,  you have  practice a minimum of two years at the same place before you can apply for board certification.  I’d like to see Dr. Adams CV and check his dates…If Dr. Adams fudged his past, shame on him, but it’s an unregulated world of surgery with little oversight for the consumer. That’s why I urge a thorough and independent vetting of docs you are considering…and urge you ask them for other patients you can talk to…before you go under the knife. In my new book that hits Amazon in January, “The Little Book of Lipo,” I have a chapter that offers a checklist on how to choose your surgeon to be safe, and how to prepare and recover quickly. www.theinformedchoice.com  Check out my site

Holiday Surgery:Tis the season to be golly!!

November 23rd, 2007

Golly, you look so … good, so relaxed…where did you go over the holidays?

That’s the reaction you want to your surgery after the holidays, so make sure you pick a doc who will preserve your natural beauty, not someone with radical ideas of who he or she wants you to be. You are the boss, so pick a great surgeon, slip away to bounce back and unwrap yourself at the right time.

www.theinformedchoice.com

 

 

Nose Job for Singer Deborah Gibson!

November 23rd, 2007

Her acquiline nose looked just fine to us in the Before photo in the same magazine. As for the after pic, well, it looks….BENT?

 

We thought her mini ski slope had character and gave her more sould and natural beauty that Barbie Babe. We also note she looks like she’s had a brow lift, and maybe a little botox, that gives her face a frozen look.

 

In her After shot, we looks like a 40 year old woman with bad plastic surgery when she’s 37 and so full of character in her BEFORE face.

 

What I tell my clients about nose jobs: make sure you pick a surgeon who does A LOT of noses. It’s the most difficult surgery out there to get right, and your nose will get noticed – especially if it alters the who you are in how you look.

More Cosmetic Surgery for Britney Spears?????

November 23rd, 2007

Our favorite Diva of Self-Destruction, Britney Spears, is eyeing more plastic surgery, according to the Dec. 3 issue of weekly Life & Style magazine.

 

But we’d warn our bayou babe to be careful—and don’t get nipped and tucked for all the wrong reasons—magic thinking that re-curving yourself will make all your problems, poof, go away.

 

It’s one of the first questions I ask my clients: why do you want to have a little work done? If I start hearing all about your Heartbreak Hotel: fear your man is straying, you gotta look like the Sizzle Sister next door, or in Brit’s case, marriage bust-up, DUI mashups, parenting issues, paparrazi addiction, maybe trying to win back K-Fed, well, it’s been my experience from talking to over a thousand clients (including a few stars who shall go nameless) over the years, surgery won’t salvage a dark night of the soul.

If Brit she gets her internal life straight, and starts feeling good inside her own skin, that’s the time to consider a tweak here or a tuck there. Get therapy, rehab, physically fit, work on the music, kick the CD into play…

 

From eyeing her pictures, I can see she’s had her lips injected, breasts aug, and nose done. As far as lipo and a tummy tuck, rumor has it she’s eyeing, well, Kanye’s Mom is ever on my mind, so lots of research and a top doc would be my advice, and don’t rush it.

 

The best results and happiest patients are those who get surgery for all the right reasons.