[Congressional Record (Bound Edition), Volume 145 (1999), Part 7]
[Extensions of Remarks]
[Pages 10510-10511]
[From the U.S. Government Publishing Office, www.gpo.gov]



                          CONCERN OVER SAFETY

                                 ______
                                 

                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                         Thursday, May 20, 1999

  Mr. STARK. Mr. Speaker, I rise today to express my grave concern over 
the safety of medical devices and the effectiveness of government 
agencies directed to protect the public from unsafe products. We have 
all read stories in the newspapers about drugs that have been recalled 
because they were rushed to market without adequate testing. Many 
critics of our current policies argue that we have put the profit 
motive ahead of the health and well being of patients. I agree and have 
yet another example that the system may have failed to protect the 
health of patients.
  Ethicon is a subsidiary of Johnson & Johnson and makes surgical 
equipment. It is the nation's largest manufacturer of sutures used for 
deep tissue surgeries. In 1994, Ethicon recalled over 3.5 million boxes 
of its Vicryl sutures because the sutures may have been contaminated 
during the manufacturing process. What I find especially disturbing 
about this episode is how the company and FDA responded to the problem.
  Early in 1994, Ethicon began to use a new sterilization process for 
its sutures. Shortly thereafter, the company discovered that several 
batches were contaminated. The company decided to resterilize these 
sutures and then distribute them on the market. This practice continued 
for several months. Eventually, Ethicon stopped using the new procedure 
and switched to other sterilization techniques. During this time, 
Ethicon officials never contacted FDA to report the problem it was 
having with the sterilizer. Indeed, the FDA did not discover the 
problem until it conducted one of its routine inspections. These 
routine inspections occur once every two to three years.

[[Page 10511]]

  The FDA did send a Warning Letter to Ethicon citing significant 
deviations from Good Manufacturing Practices. By September, Ethicon 
decided to recall the sutures it had produced. In other words, many 
months passed between the initial problems with the sterilization 
procedure and eventual recall. I can only speculate what would have 
happened, or not happened, if the FDA had not caught the problems with 
the sterilizer.
  The next sequence of events is what I really find troubling. Ethicon 
issued its recall according to FDA regulations. However, the letter of 
the law requires only that Ethicon contact distributors and hospitals, 
not the surgeons who use the sutures. This means that surgeons across 
the nation were performing operations and using sutures that were 
subject to a national recall. While Ethicon followed the letter of the 
law, I would think that a corporation dedicated to the health of 
patients would have take a more aggressive stance to ensure that its 
sutures would be removed from supply rooms and surgical kits.
  According to FDA documents only 2% of the suspect sutures were 
recovered in the recall. Somehow, leaving 98% of the suspect sutures on 
the market and unaccounted for seemed to be acceptable to the FDA. They 
considered the recall completed and closed in June of 1995.
  Since 1994, over 100 cases of severe postoperative infections have 
occurred in patients who claim that the infection was due to 
contaminated sutures. Lance Williams of the San Francisco Examiner has 
written a series of articles (2/21/1999 & 2/22/1999) describing the 
pain and suffering that these people experienced. Ethicon has settled 
many of these cases out of court with exceptionally strong 
confidentiality requirements. Because the records are sealed, we cannot 
determine the potential threat to public health by examining the 
details of the cases.
  We may never know with certainty whether the sutures were 
contaminated and lead to the postoperative infections. According to a 
letter from the FDA, ``Since typically, 20 units are tested per batch, 
the finding of ten units were positive results is not conclusive. It is 
difficult to conclude whether these results mean that the sutures were 
contaminated or that contamination occurred during the testing.''
  Even more amazing is the fact that Ethicon destroyed all the sutures 
recovered in the recall. Therefore, we cannot know if the recalled 
sutures were contaminated or sterile.
  Our constituents depend upon sound federal regulation to protect them 
from harm. Few of us have the technical expertise to determine which 
drugs are safe to treat what ails us or the ability to know how we may 
be infected by contaminated surgical devices. Rather, we must depend 
upon a sound system of checks and oversight to ensure that the 
medicines and tools our physicians use are good and will not harm us. 
In addition, corporations that make their money selling health products 
have the moral and ethical obligation to take every precaution to 
protect consumers.

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