Navigation Links
Clarity for Consumers on Botox Complication and Death Reports
Date:2/22/2008

NEW YORK, Feb. 22 /PRNewswire-USNewswire/ -- The Physicians Coalition for Injectable Safety has issued a statement offering consumers clarity on the safety of Botox(R) injections after reports of serious complications following treatment with Botox for clinical indications.

"Consumers who have had Botox(R) injections for cosmetic indications or who are considering Botox(R) for cosmetic indications should not be alarmed by recent reports of adverse events, but must put this report into perspective," said Coalition Leader Mark L. Jewell, MD, past president of the American Society for Aesthetic Plastic Surgery. Botox(R) has 6 FDA label approvals including cosmetic indications to treat facial expression lines caused by the contraction of facial muscles. Clinical applications of Botox(R) to treat serious neuromuscular disorders such as cervical dystonia and cerebral palsy are the source of data regarding the reported adverse events. The Botox(R) Cosmetic brand is specifically labeled and approved for cosmetic indications. Myobloc(R) is not approved for cosmetic indications.

"The present concern about adverse events following Botox treatment is focused on cases where botulinum (Botox(R) or Myobloc(R)) was injected to treat very serious neuromuscular disorders and serious medical illness," noted Coalition leader Ira D. Papel, MD, past president of the American Academy of Facial Plastic and Reconstructive Surgery. It is estimated that since 2002, 17 million injections of Botox(R) have been safely administered(1) for cosmetic purposes. A total of only 1031 adverse events have been reported with Botox or Myobloc, and the vast majority are clinical uses in patients with very serious illness. Of the 1031 reported events, 995 were considered by the FDA to be non-serious; serious complications represent one in 16,500 patients. "By comparison, the adverse event rate for aspirin is estimated to be over 300 times higher,(2)" said Dr. Papel.

"The dosing of Botox(R) to treat the medical disorders is often ten-fold the number of intramuscular units (i.u.'s) injected to treat the cosmetic patient," said Coalition leader Roger Dailey, MD, past president of the American Society for Ophthalmic Plastic and Reconstructive Surgery. "In perspective, a typical dose to treat the glabella, or furrows between the brows consists of 20 to 35 units (i.u. or intramuscular units), whereas a patient treated for a neuromuscular disorder may receive 200 or more units."

The Coalition's prevailing safety message for consumers considering or accepting treatment with cosmetic injectables is one of full disclosure, and emphasizes "Doctor. Brand. Safety":

-- Doctor: Is this treatment being recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility?

-- Brand: Is the injectable recommended approved by the U.S. FDA for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval?

-- Safety: Have the proper procedures been followed? Has the physician has evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?

Consumers who have questions about the safety of Botox(R) for cosmetic indications should discuss their concerns with a properly trained and qualified physician who regularly treats patients' cosmetic concerns with Botox(R). In addition, the Coalition offers consumers a Cosmetic Injectable Planner at http://www.injectablesafety.org that provides clarity and key steps to a safe experience with any cosmetic injectable treatment.

About Us

The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, and the American Society of Ophthalmic Plastic and Reconstructive Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.

About ASAPS

The 2400-member American Society for Aesthetic Plastic Surgery (ASAPS), founded in 1967, is the leading professional organization of plastic surgeons certified by the American Board of Plastic Surgery who specialize in cosmetic plastic surgery. With 2,100 members in the U.S., Canada, and many other countries, ASAPS is at the forefront of innovation in aesthetic plastic surgery around the world.

About AAFPRS

The American Academy of Facial Plastic and Reconstructive Surgery is the world's largest specialty association that represents over 2,700 facial plastic and reconstructive surgeons throughout the world. The AAFPRS is a National Medical Specialty Society of the American Medical Association (AMA), and holds an official seat in both the AMA House of Delegates and the American College of Surgeons board of governors. AAFPRS members are board certified surgeons whose focus is surgery of the face, head, and neck.

About ASOPRS

The American Society of Ophthalmic Plastic and Reconstructive Surgery represent surgeons qualified in plastic surgery of the eyelids and surrounding facial structures. Fellows of the Society are board certified in ophthalmology, have completed fellowships in oculofacial plastic surgery (currently two years), and perform aesthetic, plastic, and reconstructive surgery of the face, orbits, eyelids, and lacrimal system.

(1) Compilation of annual statistics reported by the American Society for Aesthetic Plastic Surgery 2002 to 2006.

(2) Quan, Dan, MS; LoVecchio, Frank, DO; Clark, Bryan, DO; Gallagher, John, MD. Prehospital and Disaster Medicine; volume 19, number 4; http://pdm.medicine.wisc.edu/19-4%20PDFs/LoVecchio.pdf


'/>"/>
SOURCE Physicians Coalition for Injectible Safety
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Clarity Imaging International, Inc. Rolls Out Mobile DEXA Program
2. A New Kind of New Years Resolution Could Bring Clarity to Americans
3. Experts Offer Clarity on Confusion Surrounding Stents
4. Consumers Offer to Pay More to Satisfy Health Demands
5. CIGNA Group Insurance Shows Consumers Theres More to Life Through a New Consumer Education Toolkit
6. Naked Juice Brings Consumers Happiness by the Billions With First 100% Juice Smoothie Containing Probiotics
7. Hospitals Agree to Pay Fees in Exchange for More Income, but Consumers in the Dark About What Theyll be Charged Under Nunez Plan
8. PA Agriculture Department Warns Consumers of Tainted Raw Milk Sold by Perry County Dairy
9. Highmark Blue Cross Blue Shield Introduces New Health Plan Comparison Tool for Consumers
10. Highmark Blue Shield Introduces New Health Plan Comparison Tool for Consumers
11. PA Department of Public Welfare Begins Outreach to Medical Assistance Consumers Following Burglary at State Office Building
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... ... February 12, 2016 , ... ... (WaaS), today announced the integration of Clarity Intelligence Platform (CIP) into Cielo®, a ... offer real-time business intelligence (BI) to their small and medium business (SMB) clients. ...
(Date:2/12/2016)... ... February 12, 2016 , ... The Jones Agency, a family ... eastern Texas, is launching a cooperative charity drive with the Tarrant Area Food Bank ... than 50,000 individuals and families in need, the Tarrant County Food Bank offers hope ...
(Date:2/12/2016)... ... 12, 2016 , ... Donor Network West, the organ procurement organization that heals ... with San Ramon Regional Medical Center. Under the collaboration, the first of its kind, ... accommodate a more certain time frame for donor families for the recovery of organs. ...
(Date:2/12/2016)... NY (PRWEB) , ... February 12, 2016 , ... ... of “Revolutionizing Cancer Care.” , The print component of “Revolutionizing Cancer ... Dallas, Pittsburgh/Cleveland, New York, Washington DC/Baltimore, and Seattle, with a circulation of approximately ...
(Date:2/12/2016)... ... February 12, 2016 , ... US Sport Camps is pleased to ... Club, located in Norwalk, serves as the host site and directing the camps is ... “We have had successful camps in recent years around Des Moines and are fortunate ...
Breaking Medicine News(10 mins):
(Date:2/12/2016)... , Feb. 12, 2016  Eli Lilly and Company (NYSE: ... decided the Alimta® (pemetrexed disodium) vitamin regimen patent would not ... UK, France , Italy ... dilute the product only with dextrose solution.  ... the UK Court of Appeal held that Lilly,s patent would ...
(Date:2/12/2016)... BUFORD, Ga. , Feb. 12 2016  OMS ... office-based dental and medical practitioners, announced today the recent ... website offers visitors a variety of features that enhance ... purchase oral surgery supplies. --> ... Supply is a fairly new company that started in ...
(Date:2/12/2016)... 12, 2016  Apellis Pharmaceuticals, Inc., today ... million Series D preferred stock financing, co-led ... Capital Group and venBio Global Strategic Fund, ... IB Investment, and Epidarex Capital. The proceeds of ... advance clinical trials in the Company,s ongoing ...
Breaking Medicine Technology: