Cosmetic Crisis On The Horizon: Unregulated Cosmetic Industry Poses Danger To Public, UK Says
The United Kingdom's National Health Service called for improved regulation of the cosmetics industry, warning that patients face risk of infection, scarring, facial paralysis, and even blindness.
The National Health Service issued a report this week following the scandal reported last year in which 50,000 women received faulty breast implants, filled not with medical-grade silicone but industrial filler normally used in mattresses. Now-defunct Manufacturer Poly Implant Prothèse, of France, began using the unapproved filler in 2001, undetected by European regulators until surgeons in 2009 began noticing an unusually high rate of breast implant ruptures.
Led by Sir Bruce Keogh, NHS medical director, the report recommends adopting new laws to protect patients for such elective medical procedures as dermal injections, which are today "no more controlled than floor cleaners." The report said patients receiving botulinum toxin injection, for example, "had no more protection and redress than someone buying a ballpoint pen or toothbrush."
The NHS report said the European market had 190 different types of dermal fillers on the market, compared to just 14 in an ostensibly better regulated U.S. market. Bruce told media it was "bizarre" that Britain allowed consumers to purchase dermal fillers on the Internet to be administered by "anybody, anywhere to anybody else," recommending that dermal fillers be treated similarly to other types of implants.
"We recognize that Europe is looking at this but in the meantime I don't think we can wait, keeping our citizens at risk," he said. "We should make fillers prescription-only in this country as soon as possible."
He said prescription rules are widely flouted for "Botox," a brand of botulinum toxin, which is a protein and neurotoxin produced by e bacterium clostridium botulinum. "All sorts of people are giving Botox, people are ordering it on the internet and giving it to themselves, giving it to their friends, there are Botox parties," he said. "It's not controlled as well as it might be."
The report further recommended that all cosmetic procedures, from breast implant surgery to simple laser hair removal, be conducted only by licensed clinicians with appropriate training — and that liability insurance only be afforded to such practitioners.
However, Jan Spivey told British media the report was "too little, too late" for victims of faulty breast implants. "We feel very disappointed indeed that here we have another report that does not address directly any of the issues facing the [PIP implant] women and provides no comfort for those of use that are still suffering with PIP implants."
The UK's Medicines and Healthcare Products Regulatory, a government agency, says that while France has reported rupture rates from the implants at about five percent, the rate is much lower in the UK at one percent, at least for now. Women experiencing ruptures reported symptoms of lumps around the implant or in the underarm, breast tissue inflammation, and a hardening of the breast. Though surgeons found eight cases of breast tumors when removing implants in France, health authorities there said there was no increased risk of cancer.
The industry is only slightly better regulated in the United States, however. "Cosmetic products and ingredients are not subject to [Food and Drug Adminstration] pre-market approval authority, with the exception of color additives," the U.S. regulator said.
However, a trade group representing a large swathe of the American industry last year asked Congress for more regulation, in an unusual twist. "Even though FDA has repeatedly stated that cosmetics are the safest products they regulate, it is time to bring FDA's statutory authority up to date," Peter Barton Hutt, representing the industry, told a U.S. House subcommittee.
The group said the $60 billion industry should not be dependent upon the current haphazard system of differing regulations across 50 U.S. states.
Below, the cable television series Nip/Tuck ran from 2003 to 2010, taking a bizzare dramatic look at the cosmetic surgery industry: