Botox Receives A Positive Opinion for Urinary Incontinence

- Botox injections can provide long-lasting bladder control for patients with neurogenic bladder
- Note: Sublimis offers different treatments with Botox in Argentina

Marlow, United Kingdom – Allergan is pleased to announce that BOTOX® (botulinum toxin type A) has received a positive opinion from the Irish Medicines Board for the management of urinary incontinence in adults with neurogenic detrusor overactivity (NDO) resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. This is an important step towards securing national licences in the 14 European countries involved in the Mutual Recognition Procedure and marks a key milestone in bringing this innovative treatment to patients suffering from urinary incontinence due to neurogenic detrusor overactivity. The positive opinion is specific for BOTOX® and is based on Allergan’s successful global phase III programme.

Between 60-80% of people with multiple sclerosis (MS) and 75-80% of people with spinal cord injury (SCI) will suffer from some degree of bladder dysfunction including urinary incontinence which can be distressing. Urinary incontinence in patients with MS or SCI is frequently caused by a condition called neurogenic detrusor overactivity (NDO), which results in involuntary contractions of the bladder during the filling stage when the bladder should be relaxed. This overactivity can lead to urinary incontinence (uncontrolled urinary leaking). Targeted injections of BOTOX® into the bladder muscle have been shown to reduce the involuntary contractions and increase bladder capacity. In turn, this reduces the number of urinary leaking episodes and may even stop leaking altogether in some patients.

In Europe, approximately 656,000 people live with MS and, on average, nearly 11,000 people are diagnosed with SCI per year. Many of these people face long-term mobility issues, yet remain professionally and socially active. Urinary incontinence can be a disabling and socially isolating condition. It is also associated with significant quality of life and emotional well-being implications such as embarrassment, low self esteem, depression and loss of independence. Other health implications of urinary incontinence in people living with MS or spinal cord injury include skin irritation and ulcers, kidney failure and recurrent urinary tract infections, which may lead to serious health consequences, if the overactivity of the detrusor muscle is not treated.

“We are pleased that BOTOX® has received a positive opinion following the Mutual Recognition Procedure for the treatment of urinary incontinence in people living with multiple sclerosis or spinal cord injury,” said Douglas Ingram, President of Allergan in Europe, Africa and the Middle East. “For many people with spinal cord injury or multiple sclerosis, gaining effective control over their bladder and staying dry can be a significant step towards improving daily functioning and overall quality of life. Our task now is to work closely with the national health authorities to secure the relevant national licences so that we can bring this valuable treatment option to patients, as quickly as possible.”

2010 Top Five Male Plastic Surgery Procedures

Statistics released by the American Society of Plastic Surgeons (ASPS) show that more men are going under the knife. Overall cosmetic plastic surgery procedures in men were up 2 percent in 2010 compared to 2009. However, many male surgical procedures increased significantly. Facelifts for men rose 14 percent in 2010 while male liposuction increased 7 percent.

2010 ASPS statistics show that men underwent more than 1.1 million cosmetic procedures, both minimally-invasive and surgical. The majority of the Men’s Top 10 fastest-growing cosmetic procedures are surgical, which bucks the previous trend of growth in minimally-invasive treatments.

“The growth in cosmetic surgical procedures for men may be a product of our aging baby boomers who are now ready to have plastic surgery,” said ASPS President Phillip Haeck, MD. “Minimally-invasive procedures such as Botox® and soft tissue fillers work to a point. However, as you age and gravity takes over, surgical procedures that lift the skin are necessary in order to show significant improvement.”

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Top Non-Surgical Facial Procedures in USA

Alexandria, VA – New survey results released by the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) showed three-fourths of the procedures performed by the Academy’s surgeons in 2010 were non-surgical procedures, highlighting a trend that more people are choosing non-surgical procedures to delay more invasive surgical procedures. The survey results also showed that the number of procedures performed annually has risen 45 percent over the last two years, with a 16 percent increase in non-surgical procedures.

A majority of surgical procedures, including facelift, revision surgery, rhinoplasty, forehead lift, chin augmentation, lip augmentation, and scar revision, increased in cost from 2009, which may be one reason why people opted for less invasive surgeries. In addition, surgeons reported performing fewer lip augmentations, hair transplants and collagen/cosmoderm/cosmoplast procedures in 2010.

“Non-surgical cosmetic procedures are an excellent option for some people, with the added benefits of lower costs and shorter recovery time; two things that are consistently important to those considering facial plastic surgery,” said Jonathan M. Sykes, M.D., President of the AAFPRS. “We have been seeing a trend over the past few years that people who want to look and feel younger and rejuvenated are turning to non-surgical, less invasive procedures to obtain the refreshed look they want.”

The most common non-surgical procedures last year were Botox and hyaluronic acid injections. Surgery is still popular, with the most popular cosmetic surgical procedures in 2010 being rhinoplasty, facelift, and blepharoplasty (eyelid surgery).

Before and After Botox Injections

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FDA approves Botox to treat chronic migraine

Note: Sublimis offers Botox Injection in Argentina

The U.S. Food and Drug Administration approved Botox injection (onabotulinumtoxinA) to prevent headaches in adult patients with chronic migraine. Chronic migraine is defined as having a history of migraine and experiencing a headache on most days of the month.

“Chronic migraine is one of the most disabling forms of headache,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Patients with chronic migraine experience a headache more than 14 days of the month. This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available.”

Migraine headaches are described as an intense pulsing or throbbing pain in one area of the head. The headaches are often accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine is three times more common in women than in men. Migraine usually begins with intermittent headache attacks 14 days or fewer each month (episodic migraine), but some patients go on to develop the more disabling chronic migraine.

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Botulinum Toxin May Offer Temporary Drooling Relief in Children With Neurological Disorders

Chicago — Botulinum toxin treatment appears to offer a temporary, short-term solution to relieve drooling in children diagnosed with certain neurological disorders, according to a report in the September issue of Archives of Otolaryngology—Head & Neck Surgery, one of the JAMA/Archives journals.

“Recent estimates suggest a prevalence of [drooling in] nearly 60 percent in children in special care school, of which 33 percent could be classified as severe,” the authors write as background in the article. “Depending on the associated neurological disorder, cognitive abilities and oral motor function, affected children may experience anything from stigmatization and social neglect to numerous daily clothing changes, perioral dermatitis [skin irritation around the mouth], aspiration pneumonia or even dehydration.”

Arthur R. T. Scheffer, M.D., of Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues studied 131 children diagnosed as having cerebral palsy or other non-progressive neurological disorder, and who also had moderate to severe drooling, to test the efficacy of botulinum toxin when used as a treatment for drooling in children with neurological disorders. For the injection of the toxin, children were under general anesthesia and the injections were limited to the submandibular glands, which are responsible for 70 percent of resting saliva production. The sublingual glands and parotid glands were not treated.

Of the 131 children participating in the study, 77 were boys and 54 girls with an average age of 10.9 (age range was 3 to 27 years). About 90 percent of the patients were diagnosed as having cerebral palsy. The researchers developed a drooling quotient to assess the severity of drooling, and this measurement served as the primary measure for both efficacy and duration of botulinum toxin treatment. At the two-month follow-up, the average drooling quotient had decreased from 28.8 (on a scale of zero to 100) at the start of the study (baseline) to 15.5 and 61 patients experienced a 50 percent reduction in the drooling quotient from baseline. At the eight-month follow up, the drooling quotient increased slightly to 18.7, but the authors noted there was still a significant difference compared to baseline assessment.

Additionally, patients benefited from the botulinum toxin injection for an average of 22 weeks and 25 percent of initial responders (11.3 percent of entire population) still showed a clinically significant response to the treatment after 33 weeks, with a handful of patients experiencing continued relief from drooling after one year. “Secondary beneficial effects following injection included improved oral hygiene (reduced perioral dermatitis or reduction in halitosis) in four patients (3.1 percent) and improved speech in another four patients. These effects generally disappeared after eight months.”

The authors conclude that their findings “indicate that most patients who initially respond well to injection can expect an effect to last between 19 and 33 weeks. Although the 46.6 percent success rate might appear low, its safety and efficacy make botulinum toxin a useful first-line invasive treatment if conservative measures have failed.”

Sublimis Argentina offers botox cosmetic injection abroad. Feel free to contact us for more information

Plastic Surgery 2009 news briefs

Cleavage Rejuvenation, Do-It-Yourself Lasers, Botox® Breast Lift – Hype or Reality?

Whether their effectiveness is fact or fiction, less invasive cosmetic procedures such as cleavage rejuvenation, do-it-yourself (DIY) cosmetic therapies, and using Botox® to “lift” the breasts are making headlines, but are they safe? Plastic surgeons will discuss if these, and more, are cutting edge new discoveries or just “buyer beware” marketing hype at the American Society of Plastic Surgeons (ASPS) Plastic Surgery 2009 conference, Oct. 23 – 27, in Seattle. Cleavage rejuvenation involves injecting a non-allergenic filler into the cleavage to alleviate wrinkles. DYI cosmetic therapies include hair removal devices, lasers, even fillers that some patients are ordering off the Internet. With a Botox Breast Lift, the toxin is injected into the chest muscles, temporarily paralyzing them, and causing the back muscles to compensate. The patient, in turn, is forced to standup straighter, thereby creating a lifted appearance in the breasts. Plastic surgeons are concerned that these may be some of the procedures consumers are turning to in the weak economy. A new procedure called Awake-Breast Augmentation, where the patient is awake during surgery and gives feedback regarding her preferred size of implant, will be examined. Additionally, the latest information on cosmetic gynecology, laser liposuction, cellulite, new fillers such as Selphyl (being touted as a new blood-based injectable), and more will be discussed.

By the Numbers:

* More than 10.4 million cosmetic minimally-invasive procedures were performed in 2008, according to the ASPS.

* Laser hair removal (1 million procedures) was among the top 5 minimally-invasive procedures and more than 400,000 patients had laser skin resurfacing in 2008.

* Cosmetic breast procedures totaled nearly 400,000 procedures last year.

Source: American Society of Plastic Surgeons

Survey Shows Majority of Respondents Openly Discuss Use of BOTOX® Cosmetic and Hyaluronic Acid Dermal Fillers

“In a similar survey issued four years ago, we dispelled the myth that Hollywood and corporate wives were the typical BOTOX® Cosmetic patient,” says ASERF President Laurie Casas, MD, a plastic surgeon practicing in suburban Chicago. “Now, demographic and perception data trends show us that aesthetic injectable treatments have continued to evolve into mainstream and accepted options for the everyday woman.”

Survey results found that the typical aesthetic injectable patient is a married, working mother between 41-55 years of age with a household income of under $100,000. The survey also found that women receiving aesthetic injectable treatments are health-conscious and philanthropy minded, with the majority incorporating exercise (95 percent) and healthy eating habits (78 percent) into their lives, and many volunteering with charitable organizations that matter to them (32 percent). In addition, nearly seven out of 10 respondents believe that BOTOX® Cosmetic (72 percent) and hyaluronic acid dermal fillers (65 percent) are important parts of their aesthetic routine.

“Interestingly, among BOTOX® Cosmetic patients, nearly seven out of 10 respondents also received treatment with hyaluronic acid fillers,” says Dr. Casas. “Most people have great success with BOTOX® Cosmetic and dermal fillers; however, we need to make patients aware that even though injectables are not ‘surgery,’ their administration is a medical procedure with risks that depend on the training and experience of the clinician, the clinical setting and the technique used.”

Additional findings of the survey found that 72 percent of respondents received BOTOX® Cosmetic injections to treat their glabellar lines – also referred to the “11” – the frown lines in between the brows, while 63 percent of those surveyed received hyaluronic acid dermal filler injections to treat their nasolabial folds – also known as the “parentheses” – the lines around the nose and mouth. A few of the most frequently cited reasons to receive treatment with BOTOX® Cosmetic was “to look more relaxed, less stressed” while patients reported choosing treatment with hyaluronic acid dermal fillers to “look more rejuvenated.”

Based on its annual survey of U.S. physicians performing cosmetic procedures, ASAPS recently reported that BOTOX® Cosmetic injections have remained the most frequently performed procedure since FDA approval of the product in 2002. Hyaluronic acid dermal fillers ranked as the third most popular procedure performed last year. ASERF conducted this follow-up survey to quantify the characteristics and opinions of the patients who receive the treatment to help its members and the public obtain a better understanding of these important modalities.

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