the reason this evening that I am asking for a 5-minute special order is to talk about some legislation that I have been working on and we have a great many cosponsors, H.R. 1323. As I begin to talk about it, Members need to understand when I first was brought to the problem's attention by some constituents of mine, I realized the first issue we need to deal with is what I call the candy effect, we need to get over the snicker factor and then really get on to dealing with the problems that some women in our country are having. H.R. 1323 deals with breast implants, an issue that has been the subject of court cases. But my concern, Mr. Speaker, is that the Federal Food and Drug Administration, who is supposed to be America's watchdog, our protector, to make sure that we are not harmed by faulty drugs or medical devices. In fact, the FDA's own Web site calls itself the Nation's foremost consumer protection agency, and we pour millions and millions of Federal tax dollars into this agency every year. Unfortunately, when it comes to medical devices, the FDA is neither our watchdog nor our protector. In May, I was disappointed to learn that the FDA approved saline breast implants for the general market. The FDA approved these breast implants despite data presented by the manufacturers showing that three out of four mastectomy patients who opt for saline breast implant reconstruction experience painful local complications.…
Editor's note · Context
Discussing H.R. 1323, legislation related to breast implants and FDA oversight.
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