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She cried sometimes because she's scared other people will suffer the way she has because of what she considers a governmental mistake.

And sometimes she cries because it hurts.

The Huntsville resident is one of thousands who received a Teflon-coated surgical implant expected to cure temporomandibular joint disorder (TMJ), an excruciating jaw ailment.

The joint connects the lower jay to the skull just in front of the ears and controls chewing, speaking, yawning and swallowing.

Hightower's jaw was fractured by a pit bulldog in 1983. She had surgery in 1985 when the Vitek implant was placed in her face. She was 37 years old.

Ten years and thousands of dollars later, she found out the Food and Drug Administration investigated and recalled the Vitek implant. She immediately had it removed. But she says it was too late.

"I'm eventually going to die from this," she said. "It's going to kill me one day. There nothing that can be done. You come to a point in your life where you realize no one can save you. They can't fix it - they don't know how."

Hightower, a former insurance adjuster, moved from Dallas to Huntsville with her husband Antonio to be closer to her children. She fights migraines and severe jaw pain almost daily. She is frequently regulated to a soft diet and can barely swallow.

"I think they're a bunch of cowards," Hightower says of the FDA and many doctors who keep information from their patients in fear of lawsuits. "This is killing people. No one should have to go through this."

Vitek, Inc. of Houston made the implants and eventually declared bankruptcy. Hundreds of pending lawsuits are documented.

The inventor, Charles Homsy, estimated in a Health and Science article that about 10,000 were implanted. The basic ingredient of the Vitek implant is a Teflon compound called Proplast, invented by Homsy in the mid-1960's. No approval of medical devices by the FDA was required at the time of this invention.

The FDA Center for Immunology reported it was given authority under the Federal Food, Drug and Cosmetic Act to regulate medical devices in 1976, including TMJ implants.

Devices that were on the market before the laws were passed were "grandfathered," the report states, which means they were allowed to remain on the market.

An FDA safety alert was mailed December 1990 to all oral surgeons associated with the American Association of Oral and Maxilofacial Surgeons.

By law, manufacturers were not required to track TMJ implants and chose not to keep implant records. Thus patients could not be identified and notified directly, the report states.

Hightower will go through her sixth jaw surgery at the end of this year. Although her implant was removed, the Teflon in the product crumbles into sandlike grains that the body cannot metabolize. This can - and did in Hightower's case - create a "giant cell" reaction, where the body tries to engulf the foreign matter, erupting inflammation.

The giant cell is growing at the base of her spine.

"I try not to even think about it," she said. "The pain from TMJ is so severe, you feel like you're dying. It hurts that bad."

Hightower argues that the FDA knew for years that the product was harmful and did little about it. Now that they realize they were mistaken to keep Vitek on the market, they won't admit their mistake, she says.

"We have nobody to help us, nowhere to turn," Hightower said. "Every time we opened a door, it was closed in our faces. We are living in a country that is quick to jump and run to the aid of others. But when a mistake was made by the FDA, they do everything they can to cover it up."

FDA's Device Tracking Regulation became effective on August 29, 1993. The regulation requires manufacturers, distributors and hospitals to establish systems to track those medical devices that are subject to regulation, including jaw implants.

In March 1990, Vitek issued a safety alert to oral surgeons and consignees asking they stop using the interpositional implant. FDA notified the firm in May 1990 [that] this action was considered a product recall.

The FDA report says that, in October 1990, because Vitek continued to market TMJ products and surgeons were using the products, FDA seized all the TMJ products and any devices in the process of being manufactured from this manufacturer and subsidiaries.

Hightower says she does intend to take legal action, but her primary concern is to notify others with TMJ about the harmful implants and the necessity to immediately remove them.

"Some people still don't know it's been recalled," she said. "And Vitek is not out there anymore, but other implants are."

A $22 million settlement fund set up in the bankruptcy of Vitek and its subsidiaries has 2,300 claimants.

A Woman's Day article on TMJ states the inventor claims problems are caused by poor technique or patient failure to follow a conservative post-surgical regimen.

Hightower said many TMJ patients are suicidal.

"Praying is the only thing that's going to keep suicide off my mind and the devil out," she said.

And she has another motivating factor.

Hightower's friend, Adina Booker of Orange, developed TMJ problems following a tonsillectomy. On April 21, after 26 TMJ-related operations, Booker died at the age of 30.

Hightower, who shows little emotion at her own loss, wipes away tears when talking about Booker.

"She never had a chance at life," Hightower said. "The people who did this to her are such cowards, they can't even admit what they've done. That's what gave me the will to fight for this thing, and if I have to scream it from the mountaintop, somebody is going to listen."

Hightower said those who suffer from TMJ should visit the survivors' website at http://www.tmjd.com.

"My goal is to keep this from happening to others," she said. "You need to have friends - you don't need to be isolated. The only thing we can do is offer each other comfort and walk each other through the bad parts."

Any one who suffers from a TMJ disorder and would like to help start a support group is encouraged to contact Dessie Hightower at prince@lcc.net.