March 16th, 2007

"Hernia Patch Questions"

Late in 2005, C.R.Bard Inc. issued a recall of the composix hernia patch , which is manufactured by its subsidiary, Davol Inc. The recall urged doctors to stop using the larger iterations of the product because a plastic ring in them was prone to breaking and cutting through internal organs and tissues. However, an FDA investigation found indicators that the company had known about the dangers the product posed long before the recall was issued.

The kugel mesh patch case may be indicative of a larger, more serious problem: some large medical device manufacturers seem to not be accurately monitoring and reporting the safety of their products.

The Investigation

Since the patch recall, the Food and Drug Administration had received more than 80 reports of injuries and other serious medical problems potentially related to it, including several deaths.

Bard had claimed that it did not recall the product sooner because the complaints they received were too few and unrelated. The company also claimed that it and its subsidiary had acted responsibly.

However, when FDA officials investigated the matter early in 2006, they found several “discrepancies” and “inconsistencies” in how Davol recorded, tracked, and analyzed complaints related to their patches. The FDA also discovered that Davol failed to accurately report to it the severity of some of the complaints, according to the inspection report.

Regulation Changes Needed?

FDA rules require implantable medical device manufacturers to have a system in place to collect and scrutinize complaints they receive from hospitals and doctors. These regulations also require manufacturers to report to the FDA any indication that a device's failure may have caused or contributed to the death or injury of a patient.

But the FDA gives these manufacturers the freedom to set up their own recording and reporting systems along with their own guidelines to determine when it is necessary to notify the FDA of adverse events. Some would like to see this changed.

“If a doctor holds a device in their hand that might fail and you know about it, then the doctor needs to know about it,” said Kenneth W. Goodman, co-director of the University of Miami ethics program.

Harmed by a defective medical device? Please contact us today for a free consultation with an experienced attorney who can help you plan the best recourse.