Guest guest Posted November 26, 2003 Report Share Posted November 26, 2003 Barbara, Yes, I had faulty valves on my McGhan implants as well. I also had the pathogenic colonization of my implants. It appears that many McGhan styles had a faulty valve, and Dr. Blais testified about this to the FDA in March of 2000. Patty ----- Original Message ----- From: barbsul2002 Sent: Wednesday, November 26, 2003 1:20 PM Subject: Faulty valve I just got a letter from Dr. Blais and it said my McGhan implants had a faulty valved that leaked fluid from the outset. Also, it said it showed severe colonization of at least 2 viable micro-organisms and my capsules showed stagnant fluid pockets. I am still waiting for the whole report but did anyone else have this faulty valve,severe colonization,etc? Any info or advice pleaseThanks,Barbara Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 26, 2003 Report Share Posted November 26, 2003 Barbara, if you had a faulty valve, did it totally deflate? It sounds so disgusting! How long did it take for you to get those results? Pam --- In , " barbsul2002 " <BARBY4271@A...> wrote: > I just got a letter from Dr. Blais and it said my McGhan implants had > a faulty valved that leaked fluid from the outset. Also, it said it > showed severe colonization of at least 2 viable micro-organisms and > my capsules showed stagnant fluid pockets. I am still waiting for > the whole report but did anyone else have this faulty valve,severe > colonization,etc? Any info or advice please > > Thanks, > Barbara Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 27, 2003 Report Share Posted November 27, 2003 Pam, The faulty valve does not mean that the implant totally deflates. What it means is that the two pieces of the valve system are not tight enough to prevent the system from working like a pump, allowing contaminants into the implant and vice versa. At least that is how I understand Dr. Blais's description of it. See his testimony here: http://www.cosmeticsupport.com/info/fda3-1.html#BLAIS He says: Now, what I wish to impress on you is that the mention of science in the study, the retrospective study is one thing, and that may be so, but the mention of science in the context of fabrication and engineering of the implant is not here. I have never seen any evidence of intelligent engineering or science in the design, the fabrication or, for that matter, the post explantation analysis of these devices. They are articles of commerce of very low grade. They belong to technology. They do not belong to science. Those of you who still hold the view that these things are scientific need only look at a few. I have some here. I won't bore you with that they are like, except to mention the part that I wish to draw attention to. Virtually anything we have pulled out of patients over the last years that have not been outright broken amongst the salines were all septic, septic to a level which is unprecedented in studies on scientific implants. They were visibly contaminated with all types of flora, something that by itself should be a sobering thought for any physician who puts them in and who takes them out. What I want to draw your attention to is a very small segment of our study which has concerned saline implants. Two hundred and forty-two implants that fall into a certain category, a subclass of saline implants, 74 that fulfill criteria of being "intact" in the surgical sense of the word, six of the users reporting problems prior to removal, such as deflation, a few of them claiming systemic complications -- I'm not competent to discuss it -- three users only involved in litigation. Out of these 74, 12 were very old implants, what we call the Mark I, which is a unique implant introduced in 1968 with a very coarse and, by the way, highly secure valve system. These are the ones that habitually are removed without rupture. It's an interesting observation. The others, 62 of them, bearing the same type of valve, this is what we call a forward valve or an apex valve. Those of you familiar with the trade will know what this symbols is. It is simply a hole with a diaphragm at the bottom and a plug at the top to cap it. The early ones, the , were quite secure. The second generation which was introduced in '76 is not, nor is it designed to be, as best as I can figure out. This type of implant is designed to leak intentionally to support a claim of control of contracture. It is by itself an engineering misrepresentation. It is not a single product. It is made by nearly everyone in the trade. More than 18 different manufacturers have made it. The values all share the same process, the same problem because they all come from the same place. They are a commodity. They are an article of commerce marketed by a single manufacturer, sold to others. Now, the other part of importance in this sub-study is that not only were the values of this design not terribly good in terms of manufacturing, but they did not even fit. The parts were not mated correctly. To put it in very vulgar terms, it was like having a cork on a wine bottle which is about five millimeters smaller than the hole, so that if you put the cork in the bottle, it falls to the bottom. Now, I ask you as a technologist, as a scientist, as a physician, as an administrator, as a layman, as a user, what would you think of a company that presents to you with an elaborate pre-market submission claiming elaborate studies and good science and good engineering, who cannot manufacture an object to the right dimensions? What credibility will the PMA have? ----- Original Message ----- From: Pam Sent: Wednesday, November 26, 2003 3:25 PM Subject: Re: Faulty valve Barbara, if you had a faulty valve, did it totally deflate? It sounds so disgusting! How long did it take for you to get those results? Pam Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 27, 2003 Report Share Posted November 27, 2003 Pam, No it did not deflate. It took me a month to get the letter and I have to pay to get my report. The letter was just a brief description of his findings. Barbara -- In , " Pam " <nannapam37@y...> wrote: > Barbara, if you had a faulty valve, did it totally deflate? It > sounds so disgusting! How long did it take for you to get those > results? > > Pam > > > > I just got a letter from Dr. Blais and it said my McGhan implants > had > > a faulty valved that leaked fluid from the outset. Also, it said > it > > showed severe colonization of at least 2 viable micro-organisms and > > my capsules showed stagnant fluid pockets. I am still waiting for > > the whole report but did anyone else have this faulty valve,severe > > colonization,etc? Any info or advice please > > > > Thanks, > > Barbara Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 27, 2003 Report Share Posted November 27, 2003 Patty, Is there any compensation for an implant that had a manufactures defect? I am sure the answers no, but in the letter it says " Reimbursability criteria from McGhan comprise situations where the implant shows manufacturing defects. " what does that mean? Barbara > Pam, > The faulty valve does not mean that the implant totally deflates. What it means is that the two pieces of the valve system are not tight enough to prevent the system from working like a pump, allowing contaminants into the implant and vice versa. At least that is how I understand Dr. Blais's description of it. See his testimony here: > http://www.cosmeticsupport.com/info/fda3-1.html#BLAIS > > He says: > Now, what I wish to impress on you is that the mention of science in the study, the retrospective study is one thing, and that may be so, but the mention of science in the context of fabrication and engineering of the implant is not here. I have never seen any evidence of intelligent engineering or science in the design, the fabrication or, for that matter, the post explantation analysis of these devices. They are articles of commerce of very low grade. They belong to technology. They do not belong to science. > > Those of you who still hold the view that these things are scientific need only look at a few. I have some here. I won't bore you with that they are like, except to mention the part that I wish to draw attention to. > > Virtually anything we have pulled out of patients over the last years that have not been outright broken amongst the salines were all septic, septic to a level which is unprecedented in studies on scientific implants. They were visibly contaminated with all types of flora, something that by itself should be a sobering thought for any physician who puts them in and who takes them out. > > What I want to draw your attention to is a very small segment of our study which has concerned saline implants. Two hundred and forty- two implants that fall into a certain category, a subclass of saline implants, 74 that fulfill criteria of being " intact " in the surgical sense of the word, six of the users reporting problems prior to removal, such as deflation, a few of them claiming systemic complications -- I'm not competent to discuss it -- three users only involved in litigation. > > Out of these 74, 12 were very old implants, what we call the Mark I, which is a unique implant introduced in 1968 with a very coarse and, by the way, highly secure valve system. These are the ones that habitually are removed without rupture. It's an interesting observation. > > The others, 62 of them, bearing the same type of valve, this is what we call a forward valve or an apex valve. Those of you familiar with the trade will know what this symbols is. It is simply a hole with a diaphragm at the bottom and a plug at the top to cap it. > > The early ones, the , were quite secure. The second generation which was introduced in '76 is not, nor is it designed to be, as best as I can figure out. This type of implant is designed to leak intentionally to support a claim of control of contracture. It is by itself an engineering misrepresentation. It is not a single product. It is made by nearly everyone in the trade. More than 18 different manufacturers have made it. The values all share the same process, the same problem because they all come from the same place. They are a commodity. They are an article of commerce marketed by a single manufacturer, sold to others. > > Now, the other part of importance in this sub-study is that not only were the values of this design not terribly good in terms of manufacturing, but they did not even fit. The parts were not mated correctly. To put it in very vulgar terms, it was like having a cork on a wine bottle which is about five millimeters smaller than the hole, so that if you put the cork in the bottle, it falls to the bottom. > > Now, I ask you as a technologist, as a scientist, as a physician, as an administrator, as a layman, as a user, what would you think of a company that presents to you with an elaborate pre-market submission claiming elaborate studies and good science and good engineering, who cannot manufacture an object to the right dimensions? What credibility will the PMA have? > > ----- Original Message ----- > From: Pam > > Sent: Wednesday, November 26, 2003 3:25 PM > Subject: Re: Faulty valve > > > Barbara, if you had a faulty valve, did it totally deflate? It > sounds so disgusting! How long did it take for you to get those > results? > > Pam Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 27, 2003 Report Share Posted November 27, 2003 That I am not sure about. I have not tried to litigate, and this question is probably best for an attorney or someone who has more knowledge about how many cases are winnable with a defect such as a faulty valve. I have heard nothing in 6 years in this issue about what constitutes a manufacturing defect, other than this seemingly consistent valve issue with salines. Rogene, do you know? ----- Original Message ----- From: barbsul2002 Sent: Wednesday, November 26, 2003 4:22 PM Subject: Re: Faulty valve Patty,Is there any compensation for an implant that had a manufactures defect? I am sure the answers no, but in the letter it says "Reimbursability criteria from McGhan comprise situations where the implant shows manufacturing defects." what does that mean?Barbara Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 28, 2003 Report Share Posted November 28, 2003 Patty, I was wondering what exactly I got ill from, was it the colonies of bacteria in the implant leaking through the valve or the silicone in the shell or both? Also, how do I get rid of the staphlococcus dermatitis bacteria and all the others I have? I spoke to Dr. Blais and he seems to think my body will get rid of it on its own. Barbara > Barbara, > Yes, I had faulty valves on my McGhan implants as well. I also had the pathogenic colonization of my implants. It appears that many McGhan styles had a faulty valve, and Dr. Blais testified about this to the FDA in March of 2000. > > Patty > ----- Original Message ----- > From: barbsul2002 > > Sent: Wednesday, November 26, 2003 1:20 PM > Subject: Faulty valve > > > I just got a letter from Dr. Blais and it said my McGhan implants had > a faulty valved that leaked fluid from the outset. Also, it said it > showed severe colonization of at least 2 viable micro-organisms and > my capsules showed stagnant fluid pockets. I am still waiting for > the whole report but did anyone else have this faulty valve,severe > colonization,etc? Any info or advice please > > Thanks, > Barbara Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 28, 2003 Report Share Posted November 28, 2003 I don't think anyone really knows what we are all sick from. It may be one or the other or both. (pathogens or silicone) Everything has had implications, although there are those with vested interests who will insist that silicone is inert. (It is not.) I think we just have to take the stance that the silicone has got to go, and the body needs to be detoxed and pathogens dealt with. This will give us the best opportunity to find complete healing. I think our bodies will try to heal on their own, but there are just so many things we can do to help them along the way, and strengthen the immune system. I've listed alot of natural healing methods in our archives, so be sure to check them out. Garlic is my number one favorite to recommend, as you all know by now! Then there is oregano oil, olive leaf extract, grapefruit seed extract, and coconut oil. I am sure there are others, but these can get you started. Do an internet search, and you will find scads of information to help you out. Wishing you the best in healing, Hugs, Patty ----- Original Message ----- From: barbsul2002 Sent: Friday, November 28, 2003 10:33 AM Subject: Re: Faulty valve Patty,I was wondering what exactly I got ill from, was it the colonies of bacteria in the implant leaking through the valve or the silicone in the shell or both? Also, how do I get rid of the staphlococcus dermatitis bacteria and all the others I have? I spoke to Dr. Blais and he seems to think my body will get rid of it on its own.Barbara Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 28, 2003 Report Share Posted November 28, 2003 Just to add my two cents to this issue, I also was told I had the faulty valve on my McGhan textured implants. I was told it was only on one side, ironically the side that hurt more than the other. My implants never were totally comforatble, they always hurt on the understide of each breast. Dr Feng told me this was where I had thick inflammed scar tissue. It was not something I could feel to the touch however, they were firm feeling to me, but Dr's that I had seen told me they felt soft for saline, ha ha go figure that one out! Quote Link to comment Share on other sites More sharing options...
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