Guest guest Posted July 1, 2003 Report Share Posted July 1, 2003 I wrote to the FDA and told them a doctor told me I have an autoimmune disease cause from my saline-filled breast implants and then I asked why they are on the market if they cause disease.......etc. This is the expected response I got........ _______________________________________________________________________________________ This is in response to your email to the Food and Drug Administration (FDA), regarding saline -filled breast implants. The FDA regulates medical devices and radiation products so that they are safe and effective for their intended use. The FDA has no jurisdiction over physicians. Physicians are under the jurisdiction of the state in which they practice medicine. The FDA has no significant evidence that saline-filled breast implants cause illness. For the latest FDA information on breast implants, please go to the following website: http://www.FDA.gov/CDRH/breastimplants/ I hope the information I've provided is helpful. M. Leonard Public Health Advisor Consumer Staff, HFZ-210 Division of Small Manufacturers, International, and Consumer Staff Office of Health and Industry Programs Center for Devices and Radiological Health Phone: 1-800-638-2041 extension 141 Fax: 1-301-443-9535 This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 7, 2003 Report Share Posted July 7, 2003 , That's pretty scary about the convulsion! Wow, I bet your husband was pretty freaked about that! How are you feeling now? Please let us know how your follow up went. I hope you are feeling alot better. I know it is too soon after explant to be feeling great, but hopefully you are feeling alot of relief and doing okay from surgery. Hugs, Patty ----- Original Message ----- From: Sent: Wednesday, July 02, 2003 10:02 AM Subject: Re: FDA Response Hello Everyone... Just an update. Feeling a little better. Been sleeping alot. I have been having a strange tingling in my left leg since the operation. Kind of tickles. I took a vicodin before bedtime last night and woke up having a wierd dream and my head did not feel quite right. I was shaking my head and I think shouting something. My husband said it was as if I was having a convulsion. Otherwise, some things are getting better. The heat s not bothering me like it used to. Almost immediate relief from the nasuea from that symptom and it is rather hot these days. Brain is still groggy. Just very sleepy, I think I have had too much sleep. Incredible how much fluid drains as well into the tubes. I see Dr. Lee for a follow-up tomorrow.... Quote Link to comment Share on other sites More sharing options...
Guest guest Posted July 7, 2003 Report Share Posted July 7, 2003 Hello Patty... It was not a convulsion, thank God. Just a really bad dream from the Vicodin. I stopped taking it and am taking extra strength tylenol. The drains are still draining about 15cc-20cc every 12 hours now. I really want them out, one side is starting to get a little sore where the drain is and I hope it is not infected. Otherwise I am feeling fine. I tried to do to much. Being down like this is hard. I had an appt last Wednesday and everything seems to be healing up just fine. Dr. Lee did a great job. I really do think I will be happy with the end result----escpecially sense he took out "d" cup 550cc and I am back to an "a". I really only got implants because of my breast shape, it was 'tubular' as the doctor's say. He did a total capseclectomy, a lift, reshaped my nipples (again, had it done with my first PS) and removed the saline impants. The scars go around the nipples, he went through the old scars which I had when I was implanted, as well to fix my shape 3 years ago. Since the bandages came off last Wednesday, I like what I see, I am wearing a zip up sports bra for support and have pinned the drains to it. Thank you for all the support. I am getting better. Take care.... ----- Original Message ----- From: *~Patty~* Sent: Monday, July 07, 2003 7:40 AM Subject: Re: FDA Response , That's pretty scary about the convulsion! Wow, I bet your husband was pretty freaked about that! How are you feeling now? Please let us know how your follow up went. I hope you are feeling alot better. I know it is too soon after explant to be feeling great, but hopefully you are feeling alot of relief and doing okay from surgery. Hugs, Patty ----- Original Message ----- From: Sent: Wednesday, July 02, 2003 10:02 AM Subject: Re: FDA Response Hello Everyone... Just an update. Feeling a little better. Been sleeping alot. I have been having a strange tingling in my left leg since the operation. Kind of tickles. I took a vicodin before bedtime last night and woke up having a wierd dream and my head did not feel quite right. I was shaking my head and I think shouting something. My husband said it was as if I was having a convulsion. Otherwise, some things are getting better. The heat s not bothering me like it used to. Almost immediate relief from the nasuea from that symptom and it is rather hot these days. Brain is still groggy. Just very sleepy, I think I have had too much sleep. Incredible how much fluid drains as well into the tubes. I see Dr. Lee for a follow-up tomorrow.... Quote Link to comment Share on other sites More sharing options...
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