Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, February 7, 1995 TAG: 9502070067
SECTION: VIRGINIA PAGE: C-5 EDITION: METRO
SOURCE: SANDRA BROWN KELLY STAFF WRITER
DATELINE: LENGTH: Medium
Carol Fielder of Stewartsville and Cindy Ring of Vinton chronicled their back operations and battles with pain in a story that appeared in this newspaper Jan. 16. They are among 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 and the surgery was unsuccessful.
After the story appeared, the women heard by telephone or letter from more than 100 people who had experienced similar problems, Fielder said Monday.
Calls came from as far away as Chesapeake and Charlottesville, she said.
Fielder and Ring did not know each other before their surgeries. They were introduced by their hairdresser, who had heard each talk about her back problems.
After they met, they learned that support groups had formed in several cities for people who had the hardware in their backs. Several group lawsuits have been filed against the manufacturers of the screws, which had not been approved for use in the pedicles, or bony ridges of the vertebrae.
The local group, People Against Pedicle Screws, PAPS, will meet at 7 p.m. at Thrasher Memorial United Methodist Church. Also on Thursday, the women will discuss the support group and tell personal stories beginning at 9 a.m. on WFIR Radio in Roanoke.
At Thursday's meeting, Fielder said they will be trying to gauge the interest in a local support group and will share material they have accumulated about the screws and the lawsuits.
In late January, Sofamor Danek of Memphis, Tenn., one of the manufacturers of the back screw systems, got approval from the Food and Drug Administration to market their use for treatment of severe spondylolisthesis of the fifth lumbar vertebrae.
The condition is a defect in the construction of the bone usually caused by development or fracture, said Mark Merrill, Sofamor vice president and treasurer.
The FDA clearance also specifies that the screws can be marketed only for use in people who are having the metal removed after the spinal fusion is complete. Previously, physicians who used hardware in back surgeries indicated that the metal could remain indefinitely.
A spokesperson for the FDA said last week that the Sofamor Danek approval was for a "very narrow" usage and did not constitute a blanket approval of the screws.
Lack of FDA approval does not prohibit doctors from using the devices, however. Lewis-Gale Hospital in Salem allows use of the Sofamor Danek brand of screws only, an administrator there said.
by CNB