Pharmaceutical

Hernia patch recall long awaited

With the constant advancements in medical practices and technology, it is sometimes easy for medical professionals to become too confident in their abilities and overlook the underlying facts that are in front of them. This degree of confidence may have been the case for the recall on the Kugel hernia patch made by Davol, a subsidiary of C.R. Bard Inc., which now is paying for its apparent lack of concern over product safety.

In a 2007 New York Times article, stories and accounts were told about problems and recalls on the Kugel hernia patch. However, these 2007 reports involving the hernia patch were not the first of reported problems and certainly not the last as cases continue to arise.

The NY Times article reports that when the largest patch was introduced in 2002, U.S. Food & Drug Administration (FDA) records show that complaints were reported about broken rings in the “extra large” version. Yet nothing was done.

In mid-2005, Davol received 10 complaints about ring breaks over a three-month period, but six of those reports all came from the same doctor and therefore the blame was placed on the doctor. Davol still refused to look at the product being at fault.

In December 2005, tests were run by Davol on the failed patch and the results showed that the doctors were not at fault, but in fact the product was flawed. The ring break was caused by a failure at the ring weld, resulting in bowel perforations and/or abnormal passageways between intestines and other organs.

However, I must bring up that this discovery by Davol was made in late 2005, but this article was published in March 2007. Why did it take so long for the general public to be made aware of the defective patch? The FDA notified healthcare professionals in 2005, and expanded the recall twice, in 2006 and in 2007. But the general public is still largely unaware of problems with the patch. This amount of time is too long to announce a problem or recall in a product when reliable evidence is at hand and people are being injured as a result.