My silicone implants are leeking and I'm having a lot of problems with my joints (knees, shoulders, ankles, hips). I was told it was from the silicone going thru my body.
Answer: Silicone appears safe but there are things you should know. Good question June - Implants were first introduced in 1962 and there have been over 250 types have been created. The Food and Drug Administration has been regulating medical devices in 1976. You are probably aware of the media spectacle regarding implants in the 1980’s when allegations that silicone gel implants could be linked to cancer, autoimmune and connective tissue disorders (such as lupus). Numerous lawsuits were filed and millions of dollars were paid to settle the resultant lawsuits. Admist these problems, the FDA requested more stringent safety data. There was a lack of this safety data and the FDA banned the general use of gel implants for augmentation, with the exception of women who required breast reconstruction subsequent to breast cancer and mastectomy. Fourteen years after the ban, in 2006, studies by the Mentor company in which 1007 women were followed for 3 years (with MRI results 1 and 2 years after implantation) and similar studies by Allergan (601 women were followed for 4 years) were deemed adequate to demonstrate safety and the FDA gave a qualified approval for silicone gel implant use. There were several other studies which also looked at the overall safety of silicone in the body. Interestingly several studies discovered that the highest level of silicone exposure and silicone within the body came from diabetics. Silicone coated needles used for insulin injection over years likely create significantly higher silicone concentrations than implants. Silicone is likely safe but here are things you should know. The implants will not last forever. They are devices that may need to be replaced. If the implants are removed the breasts will not return to their original shape and may look worse than before. (In other words scars and the changes from implant placement are permanent.) When the implants are replaced there is a higher risk of complications compared to the first time. Mammograms may be more difficult to read and may require additional views or other modalities (CT or MRI). There are on-going studies regarding newer silicone implants. Mentor and Allergan are providing on-going follow-up of the initial women who participated in the core studies for 10 years and also provide a separate 10 year post-approval study on approximately 40,000 silicone implant patients and a control group of women with saline implants. Silicone implants are difficult to detect rupture or leaks and MRI exams starting 3 years after implantation and every 2 years thereafter are recommended for surveillance. As always, you should discuss these issues with a board certified plastic surgeon. Implants that are leaking should be removed however based on the science we have they are not likely contributing to your symptoms. I hope this helps.
Helpful 6 people found this helpful
Answer: Silicone appears safe but there are things you should know. Good question June - Implants were first introduced in 1962 and there have been over 250 types have been created. The Food and Drug Administration has been regulating medical devices in 1976. You are probably aware of the media spectacle regarding implants in the 1980’s when allegations that silicone gel implants could be linked to cancer, autoimmune and connective tissue disorders (such as lupus). Numerous lawsuits were filed and millions of dollars were paid to settle the resultant lawsuits. Admist these problems, the FDA requested more stringent safety data. There was a lack of this safety data and the FDA banned the general use of gel implants for augmentation, with the exception of women who required breast reconstruction subsequent to breast cancer and mastectomy. Fourteen years after the ban, in 2006, studies by the Mentor company in which 1007 women were followed for 3 years (with MRI results 1 and 2 years after implantation) and similar studies by Allergan (601 women were followed for 4 years) were deemed adequate to demonstrate safety and the FDA gave a qualified approval for silicone gel implant use. There were several other studies which also looked at the overall safety of silicone in the body. Interestingly several studies discovered that the highest level of silicone exposure and silicone within the body came from diabetics. Silicone coated needles used for insulin injection over years likely create significantly higher silicone concentrations than implants. Silicone is likely safe but here are things you should know. The implants will not last forever. They are devices that may need to be replaced. If the implants are removed the breasts will not return to their original shape and may look worse than before. (In other words scars and the changes from implant placement are permanent.) When the implants are replaced there is a higher risk of complications compared to the first time. Mammograms may be more difficult to read and may require additional views or other modalities (CT or MRI). There are on-going studies regarding newer silicone implants. Mentor and Allergan are providing on-going follow-up of the initial women who participated in the core studies for 10 years and also provide a separate 10 year post-approval study on approximately 40,000 silicone implant patients and a control group of women with saline implants. Silicone implants are difficult to detect rupture or leaks and MRI exams starting 3 years after implantation and every 2 years thereafter are recommended for surveillance. As always, you should discuss these issues with a board certified plastic surgeon. Implants that are leaking should be removed however based on the science we have they are not likely contributing to your symptoms. I hope this helps.
Helpful 6 people found this helpful
January 2, 2010
Answer: Silicone implants not the culprit for joint problems There is no evidence that even ruptured silicone implants cause any systemic disease. Having said that, if your implants have been demonstrated to have ruptured, they should be removed. Meet with a board certified plastic surgeon about your implants and with a rheumatologist about your joints! Good Luck!
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January 2, 2010
Answer: Silicone implants not the culprit for joint problems There is no evidence that even ruptured silicone implants cause any systemic disease. Having said that, if your implants have been demonstrated to have ruptured, they should be removed. Meet with a board certified plastic surgeon about your implants and with a rheumatologist about your joints! Good Luck!
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August 2, 2009
Answer: No link between silicone and joint problems. First. Leaking implants should be removed and replaced. Second. The Institute of Medicine study and over 400 peer-reviewed medical studies showed no correlation between silicone implants and systemic disease. Third. the new generation of silicone implants have been designed that even it there is a tear in the outer shell, the silicone inside should not leak out. Do talk to your local Board Certified Plastic Surgeon for details and the best option for you...
Helpful
August 2, 2009
Answer: No link between silicone and joint problems. First. Leaking implants should be removed and replaced. Second. The Institute of Medicine study and over 400 peer-reviewed medical studies showed no correlation between silicone implants and systemic disease. Third. the new generation of silicone implants have been designed that even it there is a tear in the outer shell, the silicone inside should not leak out. Do talk to your local Board Certified Plastic Surgeon for details and the best option for you...
Helpful
Answer: No link with any autoimmune or connective tissue disorder
You did not mention why you believe that your implant is leaking. With the new form of breast implants produced after 2009 there is little chance of the implant gel material migrating since the gel is more cohesive than it was prior to this time. Therefore it may be difficult to tell if it is ruptured since the implant tends to keep its original shape. The problem is non an emergency. You would need some type of diagnostic study to determine if it was actually ruptured such as a mammogram, MRI or ultrasound. There has been shown in numerous studies no link between silicone gel implant and any autoimmune or connective tissue disorder.
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Answer: No link with any autoimmune or connective tissue disorder
You did not mention why you believe that your implant is leaking. With the new form of breast implants produced after 2009 there is little chance of the implant gel material migrating since the gel is more cohesive than it was prior to this time. Therefore it may be difficult to tell if it is ruptured since the implant tends to keep its original shape. The problem is non an emergency. You would need some type of diagnostic study to determine if it was actually ruptured such as a mammogram, MRI or ultrasound. There has been shown in numerous studies no link between silicone gel implant and any autoimmune or connective tissue disorder.
Helpful
April 27, 2012
Answer: Leaking Silicone implants and joint pain
The anwers have said most of what needs to be said. There is no evidence that silicone implant causes any form of autoimmune diseases including joint pain. Teh FDA has established this as have 14 years of in depth study.
Helpful
April 27, 2012
Answer: Leaking Silicone implants and joint pain
The anwers have said most of what needs to be said. There is no evidence that silicone implant causes any form of autoimmune diseases including joint pain. Teh FDA has established this as have 14 years of in depth study.
Helpful