Silicone Sheeting for Keloids and Hypertrophic Scars—by Doctor’s Prescription Only
ReJuveness silicone sheeting for problem scarring was introduced in 1996. Before that the product was marketed as Silk-Skin. Silk-Skin was a prescription-only device with whats called a FDA 510 or like device to Sil-K the silicone occlusive sheeting (Degania, Israel). The product was initially marketed to and distributed through plastic surgeons, dermatologist, burn centers, hospitals, and pharmacies. ReJuveness silicone sheeting was developed by engineers from GE Silicones, the inventors of silicone.
The Scarring Patient—Abandoned by Their Doctors: A tribute to Dr. Earl Peacock
The ReJuveness marketing breakthrough came in 1996 after contacting the teacher, plastic surgeon, and scarring expert Dr. Erle Peacock. I had read his comprehensive textbook, Wound Repair, and was more than impressed by the style and depth of writing. In short, I was a fan, probably one of his only. One day I worked up the courage to call Dr. Peacock to see if I might get any insight into the present state of the art of scar management.
In an extremely congenial manner, Dr. Peacock told me he was presently working exclusively as an expert witness for the insurance companies on claims and scarring disputes. Evidently these scarring problems were being incorrectly interpreted by patients and their attorneys as resulting from bad surgical techniques. And to avoid insurance claims, the doctors were being instructed by the insurance companies to stay clear of the scarring concerns by patients. Many patients were being told by their physicians that the bad scars appeared because they were just bad healers. Dr. Peacock suggested if we really had a product that resolved these problem scars, we probably needed to go around the Doctors and market directly to the patients.
To learn more about the Founder and first Chief of UNC Plastic Surgery, Dr. Erle Peacock, Jr. (1926–2012), click here.
Fortunate FDA Ruling: Self Magazine and Condé Nast Build a Category and the ReJuveness Brand
In March 1996 we petitioned the FDA to change designation as a prescription device and get ReJuveness silicone sheeting for scar management designated as an over-the-counter non-prescription device. The FDA agreed, and ReJuveness became the first ever non-prescription over-the-counter scar management device. We started to market direct to the patients by advertising in the back of regional papers. Dr. Peacock’s abandoned patient theory was proving correct. We went down to Madison Avenue and met with the magazine publisher of Condé Nast. We presented our marketing plan to create a new over-the-counter category of scar management. The executives at Condé Nast approved and agreed to lend their creative talent to create an ad to be placed in Self magazine. We started advertising with a small ad in the back of Self, which generated a good amount of sales. Within six months we were running full-page “Heal Scars” ads in Self and every other women’s magazine. The company grew to 72 employees. The call volume was gigantic. We needed two receptionists with 35 operators taking orders 18 hours a day. Our marketing strategy was a huge success. Our sales reached $7.2 million in 1997. By 1998 we were in 2,400 pharmacies.
Many other companies selling scar management products companies followed the lead of ReJuveness into the over-the-counter marketplace. Doctors also seemed happy and content to send their patients with scarring problems to the internet and drug stores to purchase.
The Category of Scar Management Stalls Because of the Junk Science of Plastic Surgeons
Much confusion still exist in the category of scar management. Regardless of the evidence, the FDA has made a perplexing stand about silicone, calling it “a biologically inert material.” Plastic surgeons, the original champions of scar management and masters of the scalpel, have turned on the science of wound and scar formation by also asserting that silicone is biologically inert. The scientific research produced by the field of plastic surgery, the group most predominant in scar management and silicone, is “junk science.” This present generation of plastic surgeons are no Dr. Peacock.
In regard to the positive action of silicone on these problem scars, the plastic surgeon researchers have proven to be hacks. Where breakthroughs in wound healing should have been made, they give us confusion and hypocrisy. It seems the money-making opportunities of implanting silicone breast implants trumps scientific truth and medical advancement . It’s a racket between the breast implant manufactures, the plastic surgeons, and the FDA. Some 400,000 women opted to implant silicone breast implants last year. At about $6,000 per implant operation, that is about $400,000 for each plastic surgeon per year. 25% of these women will have complications or get seriously ill. Neither safety nor efficacy—the twin pillars of FDA guidelines—exist in these terrible devices. What gives?
Studies have repeatedly shown using silicone scar sheets as a prophylactic is the only material that is effective in resolving problem scarring. The unique physiological action of silicone on scarring is acknowledged; yet the plastic surgeons’ junk science prevails. The confusion in scar management for practitioners and patients alike remains. Scam companies are allowed to make claims and sell scar management products that are toxic or don’t work.
ReJuveness has had its financial ups and downs over the years. But after 20 years, ReJuveness is still going strong, offering superior, safe, and effective scar management products. We push for legitmate science, even though that criticism will probably hurt us overall in the industry. Although we remain relatively a small company, in our eyes and those of many of our loyal customers, ReJuveness remain “The leader in scar management.”