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GDSM
Posted Mar 26, 2008 5:59 AM
Then why can't you and your colleagues do something about it? Is it etheically better to keep injuring people in the name of science than to do what is exactly better for the patient. The Manufacturer must know that their product is harmful, even if it only 10 in 1000 patients. How can science advance if all options are not on the table and the manufacturer is kept in the dark of what is happening to patients with the perfix plug and patch. Why shouldn't they want to make a better product? I can't believe that you as a doctor could ethically and morally allow people to be put in harms way. You steer people away from this product in this blog and others but why wont you tell the people that matter what happens with this product. the FDA/CDRH are waiting for surgeons like yourself and Dr. Goodyear to come out and speak of the perils ad pitfalls of this product. It seems that Adverse event submissions is not enough for the government to act upon the almost 3000 people that are suffering from not just the Perfix plug but other meshes also. Isn't there somewhere that surgeons such as yourself can report the damages being caused. For god sakes if the products need to be removed then that should be a warning sign for you and others that the product is faulty and should be reported. |
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