Orange County Register

For cosmetic medicine, news of the past year has ranged from promising new products to fears about potentially dangerous procedures.

It was an especially busy year for Botox maker Allergan of Irvine, which has faced challenges at the Food and Drug Administration, in court, and in the marketplace.

In the second half of the year, the economic slump hit, causing several cosmetic-medicine firms to go bankrupt.

Here’s a recap of the year’s events in cosmetic medicine.

January — Botox should be labeled with black-box hazard warnings, the advocacy group Public Citizen tells the FDA, citing 16 reported deaths and other serious problems that occurred in patients who received injections of Botox or the similar drug Myobloc. All but one of the deaths was after therapeutic-strength injections, which are used to treat muscle disorders. Only one was a patient who used the cosmetic form of Botox, and she died seven weeks after the injection. (Read the post)

March — The U.S. Department of Justice subpoenas Allergan for documents related to its promotion of Botox. (Read the post)

March — Stephanie Kuleba, 18, a high school cheerleader in Florida, dies of an apparently fatal reaction to anesthesia during breast augmentation surgery. The death came four months after the death of Donda West — the mother of singer Kanye West — from complications after breast reduction surgery in Los Angeles. (Read the post)

April — The toxin in Botox can travel into the brain from an injection site in facial muscles, according to Italian researchers who injected large doses of a Botox-like chemical into laboratory rats and mice. Their study was published in the Journal of Neuroscience. Allergan disputed its relevance to Botox and insisted that the company’s product is safe. (Read the post)

June — Allergan completes tests of its eyelash growth drug bimatoprost and prepares to seek FDA approval to sell it.  It’s a variation of Allergan’s glaucoma drug Lumigan, which some doctors prescribed to lengthen patients’ eyelashes after noticing that effect on their glaucoma patients. (Read the post)

July — Allergan says it expects to spend $25 million to $35 million this year in connection with a Department of Justice probe of its marketing operations, reportedly focusing on whether Allergan promoted the use of Botox as a headache treatment, which has not been approved by the FDA. (Read the post.)

July — The Irvine-based Solana medspa chain files for bankruptcy. (Read the post.)

July — Botox patients sue Allergan, accusing it of marketing Botox for unauthorized uses to doctors and patients — “as a panacea for a large assortment of illnesses and cosmetic purposes.” (Read the post)

September – Health care giant Johnson & Johnson launches its dermal filler Evolence, a competitor to Juvederm and Restylane. (Read the post)

October — Gov. Arnold Schwarzenegger vetoes a bill that would have required doctors to check a patient’s medical history and perform a physical examination before cosmetic surgery. (Read the post)

October — Mentor Corp. of Santa Barbara completes one of three clinical studies of its injectable botulinum toxin PurTox, a planned wrinkle-fighting competitor to Botox. It is expected to win FDA approval in 2009. (Read the post)  A second competitor, Reloxin from Medicis Pharmaceutical of Scottsdale, Ariz., is also expected to get its FDA okay next year. (Read the post)

November – The economic slowdown began to take its toll as Rhytec Inc. of Waltham, Mass., filed for Chapter 7 bankruptcy. Its Portrait Plasma skin-rejuvenation device used plasma-generated heat instead of laser light to stimulate the skin. (Read the post.)

December — Johnson & Johnson expands its growing presence in the cosmetic-medicine market with a $1.07 billion deal to purchase Mentor, the maker of PurTox and a line of breast implants (Photo at right shows Mentor factory in Texas.) (Read the post)

December – Eyelashes grow longer and fuller when patients use Allergan’s glaucoma drug bimatoprost, staff at the Food and Drug Administration said. Allergan expects to sell the drug under the name Latisse.  It’s likely to be available by prescription in 2009, because FDA staff and an FDA advisory panel said it’s safe and effective. (Read the post)

December – More fallout from the economic slump. Artes Medical Inc. of San Diego files for Chapter 7 bankruptcy, citing declining revenue from ArteFill, a plastic-based filler that is injected into the face to smooth folds and hollow cheeks. (Read the post.)

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