WASHINGTON -- The government Friday banned the sale of hair fibers for scalp implants, saying the practice is dangerous and does not cure baldness.
The ban, effective immediately, was the first time the Food and Drug Administration invoked its 7-year-old authority to take an allegedly dangerous medical device off the market. The FDA said it knows of no hair fiber or synthetic hair that is safe or effective for implants.
FDA officials said hundreds of consumer complaints, several legal actions, a government investigation and a 1979 public warning apparently put hair transplant clinics out of business, but it 'hopes to ensure that the dangerous practice of implanting these fibers in bald heads is never revived.'
'We don't know of any firms in the business right now,' FDA spokesman Christopher Smith said, 'but we're concerned as the word of complaints dies down. We don't want this to start back up again.'
The ban applies to synthetic fibers including polyester, modacrylic and polyacrylic, and also to some natural materials such as human hair processed for implanting on another head.
It does not apply to hair transplants, a surgical procedure in which a person's own scalp hair and surrounding tissue are grafted onto another part of the scalp.
The hair implants banned by the FDA used thousands of fibers, cost thousands of dollars, took from several days to a week and were usually not done by a doctor, the agency said.
An FDA survey in 1979 found 90 facilities operating and more opening up, with fees ranging from $1,500 to $5,000. Smith said they apparently died out a year ago.
The implants were done by weaving a plug of hair and stitching it into the scalp. Despite the clinics' claims, the fibers were not effective in simulating natural hair or concealing baldness, FDA said. The fibers usually fell out, broke off or were rejected by the body a short time later, FDA said.
From December 1978 through February 1981, FDA received 166 complaints about the fibers and the Federal Trade Commission received 181.
They included cases of infection, facial swelling, severe pain, scarring and permanent loss of remaining real hair, with many cases requiring extensive medical and surgical treatment, the FDA said. FDA officials said there also is a possible long-term risk of cancer.
In seven cases, people had to have portions of their scalp surgically removed. In 21 cases, the fibers could not be removed and the patient's scalp remained disfigured, the FDA said.
Although there are no reliable reports on how many people had the implants, 'we think the reports represent only a small portion of people who have had hair fibers implanted,' Smith said.
The FDA published its ban in Friday's Federal Register as a proposed rule subject to 60 days of public comment, but the ban can take effect immediately under authority granted by Congress.
If safe fibers are developed for hair implants, the manufacturer may apply for FDA approval to use them.
