Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: MONDAY, January 16, 1995 TAG: 9501170098
SECTION: VIRGINIA PAGE: A1 EDITION: METRO
SOURCE: SANDRA BROWN KELLY STAFF WRITER
DATELINE: LENGTH: Long
Carol Fielder and Cindy Ring share the same hairdresser in Vinton, but they wouldn't have met if not for their bad backs.
The two endure chronic pain made worse, they said, by hardware that was supposed to help their backs heal.
Fielder, from Stewartsville, and Ring, from Vinton, are among the 300,000 people who have had experimental screws put into their spines to aid the fusion of vertebrae.
In both of their cases, the screws broke, the surgery was unsuccessful, and the back pain remains - only it's worse than before, they say.
Several group lawsuits have been filed against the manufacturers of the screws, which have not been approved for use in the pedicles, or bony ridges of the vertebrae. The screws were the subject of a "20/20" television show in December 1993. Since then, a number of support groups have formed to disseminate information about the screws used in back surgery and to help sufferers find a way to deal with the discomfort they say is never-ending.
Strangers until they were brought together by the woman who styles their hair, Fielder and Ring now plan to establish a support group in the Roanoke Valley.
Fielder has joined a lawsuit filed against the screw makers by a Tulsa, Okla., firm. Ring hasn't decided whether she will join such a suit. They agree, however, that living with back pain is a daily trial. They said they are prescription drug "addicts" who must constantly battle depression because their lives are so restricted by the condition of their backs.
"I can't walk through a grocery store," Fielder said when she and Ring sat down for an interview at the Ring house.
"Sit" is not the right word to describe what these women do, however. They can't sit still for very long. Nor can they stand for very long. They lean, and they get up and down trying to stop the hurt.
Fielder, 53, has had back problems for years because of degenerative disc disease. Her back forced her into early retirement from Sears, where she had worked for 27 years. It keeps her from the outdoor activities she used to enjoy with her son, Shane, 10.
Since 1991, she has undergone surgery four times from three different doctors.
The first surgery was to repair a ruptured disc and was done with a laser. In the second, vertebrae in her lower spine were fused and a bone growth-stimulator installed. The stimulator, which is about half the size of a 9-volt battery, sends electric charges to the bone graft area.
What happened next was a nightmare, she said. During the surgery, the dura, the sac around the spinal cord, was cut and spinal fluid leaked and formed a pocket on her lower back. The batteries from the bone growth-stimulator came loose and fell into the fluid.
"I rattled when I walked," she said.
Her third surgery was to remove the bone growth-stimulater and the final was to remove the screws and other hardware put on her spine to stabilize it.
Fielder has permanent nerve damage that causes her left leg to hurt, and said she is worse off than she was before the first surgery. She takes two drugs, Darvocet and Mepergan, for pain, the anti-inflammatory drug Relafin and Axid-CP for stomach distress caused by stress and the other medications.
Ring also has nerve damage in her left leg. Sometimes, she has to use her hands to lift it and get it going.
Ring, 44, is less resigned to her condition than Fielder is to hers. Ring was a school bus driver for 12 years and used to hunt, fish and help with home renovations.
A couple of years ago, she fell while helping her husband do construction at the house and soon afterward her leg began to bother her. A family doctor told her to stay home and rest for a couple of months, but, when she returned to work, she soon found she couldn't handle the driving.
"I got to where I couldn't push the clutch in on the bus," she said.
In February 1993, she began tests that led her to decide on fusion surgery with pedicle screws, rods and plates that doctors said should enable her to return to work in three to six months. The surgery was in May. One morning in July, she felt a pain in both legs that she imagined was like being hit with an electric cattle prod.
Tests revealed that one of the pedicle screws had broken. In April 1994, she had surgery to remove some of the hardware, but the ends of the screws that had broken off couldn't be taken out, she said.
In November, Ring had surgery to remove scar tissue and a piece of the bone that had broken off the failed fusion area. She continues to have a tingling in her leg and burning pain in her hip.
"I can't work or keep my grandchildren because I can't lift them," she said. "Basically, I'm just existing."
She takes Demerol and Darvocet for pain, Oruvail for inflammation, Zantac for her stomach, and she has been on Prozac for depression.
"It's incomprehensible that I won't be like I used to be," Ring said.
It may not be possible to document that the screws put in the backs of Fielder and Ring are the source of their current troubles. But the screws, used in 50,000 to 70,000 patients a year, are center stage in a national controversy. Lawsuits, representing large numbers of patients, have been filed in Louisiana and Philadelphia against the 10 or so companies that make the screws.
A Philadelphia court is considering a proposal to merge the suits into a class action, according to Tulsa lawyer Gary Eaton. His firm of Eaton & Sparks represents more than 1,000 plaintiffs, including 10 or so from Virginia.
Back fusion surgery does fail in some people partly because it is so difficult to keep the spine stable during healing. Depending upon diagnosis and the patient group, failure rates are from 5 percent to 40 percent. And even if the vertebrae fuse, there is no guarantee that the back will be renewed.
Last March, a study funded by the Washington State Department of Labor and Industries revealed that 68 percent of the fusion patients were unable to work and 23 percent required further lumbar spine surgery two years after the initial fusion.
However, the use of screws to secure the spine has become standard practice among surgeons looking for ways to improve the outcomes of fusion surgery. The U.S. Food and Drug Administration has not approved the screws because it says it does not have enough data to assure their effectiveness and safety. The FDA also has forbidden manufacturers to promote them, but the devices can be used with patient consent.
Both Lewis-Gale and Roanoke Memorial hospitals allow surgeons to use pedicle screws, which are made under several names, including Danek, Smith & Nephrew, Depuy Motech, Acromed, EBI Medical Systems and Corin Medical.
In December, consumer activist Ralph Nader's Public Citizen group called for a moratorium on most uses of pedicle screw fixation systems and urged the FDA to push for criminal or civil penalties against manufacturers who promoted the screw systems.
by CNB