Intestinal Fistulas

Question: Should my husband have the hernia patch removed? My husband had a hernia repair in April. I received an e-mail from the maker of the "hernia patch" stated that it has been recalled. He is not having pain and his surgeon seems to think it is no big deal. This is the email: The U.S. Food and Drug Administration and Devol, Inc., a subsidiary of C.R. Bard initiated a recall on December 5th 2005 for its Bard Composix Kugel Mesh Large Oval and Large Circle Patch which were designed to treat ventricle hernias.The patch is inserted through a small incision and is placed behind the hernia. A "memory recoil ring" is used to keep the patch closed until after it has been inserted in the body.The purpose of the patch is to prevent the hernia from pushing through weakened tissue walls, specifically in cases when stomach muscles are too weak for surgery to repair the hernia. However, the "memory recoil ring" can break under the stress of placement in the body, resulting in bowel perforations and chronic intestinal fistulae.

Answer: Sometimes recalls are simply a special precaution by the manufacturer, meaning that they think the odds of failure are great enough that it is better for them to order a recall than to face possible lawsuits for not notifying everyone. Here is what I would do if I were you: You've already done the first step: getting the opinion of your husbands surgeon. Make sure his opinion is in writing somewhere in your husband's record. Second, ask him for a referral for a "second opinion". Your insurance company should allow this, since they don't want to have to pay for any of the hospitalization charges. HOWEVER, the expenses for surgery and hospitalization due to the recall SHOULD be paid by the company. You and your insurance company shouldn't have to pay a dime. Which also means that your insurance company may have a cause for action against the manufacturer, since they provided a potentially faulty device for payment in good faith. Unless everyone involved says your husband should have the surgery, you can likely trust the device not to fail, especially since it's purpose has already been served during primary, secondary and tertiary healing (6 months). April to November...he is basically out of the woods as far as a surgeon is concerned. Now, the other thing I would do is to get a PERSONAL INJURY LAWYER. Whether or not your husband has the surgery, they can be on the hook for pain and suffering, as well as possible punitive damages. You likely wouldn't take the case to court. They settle these kinds of things fairly quickly. It won't be a fortune, but it may be enough to make it worth your time. Personal Injury Lawyers won't charge you up front, and will usually only charge you if you win, by taking a percentage of the reward, plus expenses. Finding the right one...one you can trust...may be a bit of work, but you can ask around and see if anyone can recommend the right lawyer. In fact, I would do that first, before you talk to the surgeon or any other doctor or company rep. I hope all turns out okay for you.