Elaine

Government carelessness in regulating jaw implants made of silicone and Teflon has endangered thousands of Americans who received the devices for jaw disorders, doctors and patients told a congressional hearing Thursday.

Likening the regulatory problems surrounding synthetic jaw implants to those seen with silicone gel breast implants, Rep. Ted Weiss, D.-NY, criticized the FDA for not forcing makers of jaw implants to prove their safety.

Until 1976, the law did not require manufacturers to show that medical devices like jaw implants were safe and effective. After that, companies could get around providing such data if they could convince the FDA that a new device was equivalent to one sold before 1976.

“As a result of that carelessness on the part of the FDA, thousands of patients have suffered terribly from implants that never should have been allowed to be sold in the first place,” said Weiss, head of the House Resources and Intergovernmental Relations Subcommittee.

The implants, which are surgically inserted, were used to treat a painful jaw condition called temporomandibular TMD.

An estimated 10 million Americans experience painful TMD symptoms, with about twice as many women afflicted as men. About one-fifth of TMD sufferers undergo some type of surgery.

The temporomandibular joint allows the lower jaw to move. TMD can be related to chewing muscles, bone derangements or degenerative disorders like rheumatoid arthritis.

Jaw implants were intended to replace the soft tissue “disc” that acts as a shock absorber between the jawbone and the socket of the temporomandibular joint.

The implants’ popularity escalated from just a few when silicone “Silastic” implants were introduced in 1965 by Dow Corning of Midland, Michigan, to thousands when Vitek, Inc. of Houston started selling Teflon “Proplast” devices in 1983.

In the mid-1980’s, doctors began reporting side effects like bone degeneration and tissue inflammation in TMD patients with silicone or Teflon implants. In some cases, bits of the synthetic material were found in the middle ear or the brain.

Amy Marks of New Orleans received Vitek’s Teflon implants after she developed TMD in 1978. “The implants shattered and today tiny particles of Teflon are floating around in my head causing severe, constant pain,” Marks testified. “Doctors, hospitals, the federal government, the FDA and the NIH all have failed me and thousands of others who suffer because of a little piece of plastic.”

After researchers found that virtually all Teflon implants shatter, the FDA seized all Vitek imports in October 1990 and set up a registry for the approximately 26,000 patients through to have received the implants.

Vitek declared bankruptcy before the recall and its head, Dr. Charles Homsy, is now in Switzerland. Weiss read a 1984 letter to Homsy from Dr. John Kent in which Kent said a Vitek implant removed from a pain-stricken patient looked deformed and was covered with black pigment.

“We might have a calamity of unbelievable proportion on our hands,” wrote Kent, who held 21,000 shares of Vitek stock and published studies supporting the implant.