New Questions Raised on Implant Recalls


New Questions Raised on Implant Recalls


When implanted medical device products starts breaking, what is the basic human response from the creators of those devices?

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

Bard officials said recently in a statement that they had not recalled the product sooner because complaints about failures were too few and unrelated to raise any alarms. The company also said that both it and the subsidiary, Davol Inc., had reacted responsibly.

But when F.D.A. officials inspected Davol in early 2006, they apparently found other reasons that company officials and the agency might not have been alerted earlier. For example, inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints.

And, in several instances, Davol also did not accurately report the possible severity of complaints to the agency, a copy of an inspection report obtained by The New York Times under the Freedom of Information Act shows.

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So the FDA Says ‘No More Mesh’ for Hernia Repairs…


So the FDA Says ‘No More Mesh’ for Hernia Repairs…

Which came first, the chicken or the egg? Well, in this case, was it the gynecologic surgeons who were too quick to adopt mesh in the O.R. or the FDA’s 510(k) approval process was too quick to allow mesh in gynecologic surgery. Who is to blame? You can read the full story here!

The problem now is that the mesh in some procedures (but not all) has a tendency to erode — wearing through the vaginal mucosa and exposing its rough and uncomfortable surface to the patient and her sexual partner — or constrict and scar, causing tightening and discomfort.

Some of these procedures have been stunning successes. Procedures that place mesh under the urethra (the tube that carries urine from the bladder to the outside) are generally quick, require minimal recovery, are safe and are proven to cure a particular type of incontinence. (This use of mesh is not part of the FDA warning, although this distinction may be lost on patients.)

But other mesh procedures, in which mesh is used to support one or more of the vaginal walls, have led to complications. The mesh used for these surgeries is essentially the same mesh used (successfully) by general surgeons to repair hernias and other abdominal wall defects.

Medicine cross pollinates from one field to another — we call it innovation. There is a long tradition of taking drugs and devices approved for one purpose and using them for another purpose. Once a device is FDA approved, physicians can (at their peril) use them for pretty much whatever they like. So it is with mesh. I believe that making it harder to get mesh approved for hernia repairs isn’t going to make it less likely to erode into women’s vaginas — it’s just going to slow down the process of getting discoveries into the clinics and into the O.R.

And the cowboy gynecologic surgeons? These are the innovators who brought about the successful mesh sling procedures that now cure 95 percent of women of incontinence in 30 minutes (when surgeries with 50 percent success rates used to take 5 hours in the O.R. and require weeks of recovery). Millions of women have benefited from the extraordinary era of innovation in gynecologic surgery over the past 15 years. Do we really want these surgeons to stop innovating?

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