[Congressional Record Volume 145, Number 91 (Thursday, June 24, 1999)]
[Extensions of Remarks]
[Page E1389]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                             VICRYL SUTURES

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                        Thursday, June 24, 1999

  Mr. STARK. Mr. Speaker, on May 20 of this year I commented on the 
1994 recall of Vicryl sutures produced by the Ethicon Corporation. In 
my comments, I noted that according to FDA records, only 2% of the 
sutures were recovered in the recall. The numbers given to me by the 
FDA were incorrect. In fact, approximately 25% of the sutures were 
recovered in the recall. I include a letter from Melinda K. Plaisier, 
Interim Associated Commissioner for Legislative Affairs, describing the 
cause of the error and the correct facts.

                                 Food and Drug Administration,

                                      Rockville, MD, May 28, 1999.
     Hon. Pete Stark,
     House of Representatives, Washington, DC.
       Dear Mr. Stark: In the Food and Drug Administration's (FDA) 
     May 18, 1999 letter of response to your April 19, 1999 letter 
     regarding the distribution and recall of Vicryl sutures 
     manufactured by Ethicon, Inc., there was a mistake. This 
     letter is intended to correct that mistake. A response has 
     also been sent to your cosigner, Representative Henry A. 
     Waxman.
       When Ethicon originally provided distribution information 
     to FDA, the manner in which the figures were reported was 
     misunderstood by FDA. The number of sutures understood by FDA 
     to have been distributed was considerably larger than the 
     actual quantity. The 2% recovery rate therefore was 
     inaccurate. The correct recovery figure was approximately 
     25%. This is based on distribution of 293,452 dozens and 
     recovery of 72,929 dozens of sutures. If you have any 
     questions regarding this information, we would be happy to 
     discuss it with you further.
       We trust this responds to your concerns. If we may be of 
     further assistance, please let us know.
           Sincerely,

                                          Melinda K. Plaisier,

                                    Interim Associate Commissioner
                                          for Legislative Affairs.



     

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