Mesh Implant Makers Agree More Studies Needed

Those of you following this blog are aware that an  FDA Advisory Panel has been meeting the last two days to determine the future of the use of transvaginal mesh.  It is being reported today by Bloomberg BusinessWeek that some of the makers of the mesh have admitted and agreed that there is a need for more safety studies of the implants and labeling changes to warn of potential risks.  Johnson & Johnson and Endo Pharmaceuticals Holdings Inc., proposed that new versions of the mesh require clinical trials before they can be sold and those implants that already have been placed in women should be tracked for reasons of safety.  Unbelievable.  Where have these manufacturers been?  The problems with vaginal mesh have been going on for several years now, why the sudden concern?  Could it be the fact that the FDA has finally taken notice of the horrendous injuries women are experiencing and may do something about it?  Could it be the manufacturers have decided they would rather have to pay for studies, which they should have been doing all along, than have the products taken off the market?  Could it be that the cost of safety studies will be a drop in the bucket compared to the money the manufacturers make off of these devices, whereas if they are taken off the market they will make no money at all?  Oh well.  Maybe its just me.  I am a suspicious sort.

The panel heard from several women who have been injured by the implants.  Janet Holt stated "the mesh shrank 30% and eroded into the vaginal wall...each step you take rubs the open wound against the other side.  It is complete torture."  Marian Goldberg asked the panel if they would agree to have a procedure using a device "that can make it impossible for you to work or to have sexual intercourse at all?  Who among you will volunteer for a permanently implanted device that cuts through your genitalia, your urethra, or your rectum?  I don't see anyone rushing to sign up on the dotted line...Why haven't you taken these products off the market?"

Marian, the reason these products haven't been taken off the market is because they are making the manufacturers a lot of money.  They aren't going to take them off until the money they have to pay women through lawsuits and the money they lose through bad publicity outweighs the money they are making in sales.  And don't expect the FDA too solve this problem.   They will likely split the baby in their final decision; if history is any indication.