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Is breast implant surgery safe and are the implants themselves safe?

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The question over the safety of breast implants has recently surged in the media. What is interesting is that is a debate that has been going since the 1960s, but generally speaking, there are two main categories of implant related disease: Breast Implant Illness (BII) and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL).  Cutting to the chase, there are certain types of implants from which to stay away, but by and large I believe they are safe; however, some patients may choose to have their removed for a variety of reasons. 


Breast Implant Illness is a large, all-encompassing term that attempts to correlate vague, generalized symptoms into one diagnosis.  The Journal of Plastic and Reconstructive Surgery recently published an article called Breast Implant Illness, A Way Forward (Plastic and Reconstructive Surgery: March 2019 - Volume 143 - Issue 3S - p 74S–81S).  This article discusses that there have been a handful of cases reports dating from the 1960s of breast implants acting as a non-specific stimulant of the immune system. It then delves into the chemistry of silicone and discusses the difference of what is found in nature and what is in medical grade silicone.   It then touches on how the media hyped up a number of cases in the 1980s, despite the fact that the majority of patients had nonspecific symptoms and no abnormality in serological tests. Following this, the FDA mandated a moratorium in the 1990s severely limiting the use of silicone breast implants.  Clinical trials then followed, including one by MD Anderson Cancer Center which concluded no difference in the incidence of autoimmune-like disease between women with breast implants versus non-implant reconstruction.  After this, larger population-based analyses were performed and again showed no evidence of association between breast implants and a significant relative risk of individual connective tissue and autoimmune diseases.  In 2006, silicone implants were re-introduced to the US market with the stipulation that the manufacturers conduct large studies due to the lack of data.


Allergan and Mentor, two of the largest implant companies, performed a study with almost 100,000 women. Their findings showed a higher rate of Sjogren’s syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma when compared with normative data; however, this data was largely patient reported, and not standardized. Even though there was complete lack of causal evidence, this led to another rise in media attention and reigniting of the issue and therefore more studies. Of note, one recent study by Rohrich showed that there was statistically significant improvement in subjective health for patients who are distressed by their implants after removal.


The article concludes by suggesting a path forward due to the fact that the lack of robust epidemiologic evidence to support the association should not stop the pursuit of ongoing scientific evaluation and the key will be to figure out which patients benefit and why.  And although the relationship between breast implants and systemic disease, including autoimmune disease, has been postulated, studied, and claimed since the 1960s, no clear evidence exists, and the debate continues.


To change gears and discuss a different topic, textured breast implants have been correlated with a specific type of cancer called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).  Although this is still a correlation, the evidence is quite high for the association.  This cancer is typically diagnosed when a collection of fluid builds around the implant, often years later.  Research is currently ongoing trying to determine was the relationship and what the causal factor are.  Different theories exist ranging from bacteria to an inflammatory response to the texture itself and how it was made.  The prevalence of this cancer is very low, so at this time, I do not recommend electively removing implants when no other findings or symptoms exist. The good news is that we do not place textured implants at Cosmetic Surgery Affiliates anymore. 

To give a little back history, the textured implant became popularized after anatomically shaped implants were developed.  Instead of being perfectly round,  these implants were more of a tear drop shape.  The problem was that in some patients, the implant rotated after surgery, and the patient was left with a sideways breast.  Creating a textured implant made the implant “stick” to the tissue so it would not spin. After learning about the correlation with ALCL, the breast implant companies have since redirected back to the tried and true round implant, so it does not matter if it spins as it will retain the same shape.


Regardless of the lack of evidence showing any illness related to breast implants, many women find themselves desiring to have their implants removed.  The surgery required to remove the implant is very simple and takes very little time. An incision can be made in the same scar that was used to place the implant, and the implant is easily removed. 


The surgery becomes more complicated if excessive scar tissue exists. The body normally forms a scar around the implant called a capsule. In some patients, excessive scar tissue forms which can start to shrink down around the implant and make it feel hard; this is called a capsular contracture.  When the scar is soft, it can be left in place; however, when a thickened, hard capsule exists, I recommend removing it as well.  After the implant is removed, the previous pocket remains, and the empty space can collect fluid.  For this reason, I will often leave a drain for a couple days to prevent the formation the collection bodily fluids.


I always discuss the patient’s goals during consultation.  If implant removal is the only goal then, that is what is performed.  However, if the patient has concerns about feeling deflated or saggy after the implant is removed, then we discuss other options.  One option is to restore some of the volume with fat transfer to the breasts.  In essence, rearranging one’s own inventory by taking from on area such as the abdomen and then placing it in the breasts.  Another option for those who do not want the size anymore but want to be perkier, is a breast lift or mastopexy.  In this surgery, the nipple and areola stay attached but the hanging skin and glad are removed and the breast can be lifted back up to its previous location.  Many options exist, and Cosmetic Surgery Affiliates offers complimentary consultations in order to understand the patient’s goals, so that decisions can be made together.


The question over the safety of breast implants has recently surged in the media. What is interesting is that is a debate that has been going since the 1960s, but generally speaking, there are two main categories of implant related disease: Breast Implant Illness (BII) and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL).  Cutting to the chase, there are certain types of implants from which to stay away, but by and large I believe they are safe; however, some patients may choose to have their removed for a variety of reasons. 


Breast Implant Illness is a large, all-encompassing term that attempts to correlate vague, generalized symptoms into one diagnosis.  The Journal of Plastic and Reconstructive Surgery recently published an article called Breast Implant Illness, A Way Forward (Plastic and Reconstructive Surgery: March 2019 - Volume 143 - Issue 3S - p 74S–81S).  This article discusses that there have been a handful of cases reports dating from the 1960s of breast implants acting as a non-specific stimulant of the immune system. It then delves into the chemistry of silicone and discusses the difference of what is found in nature and what is in medical grade silicone.   It then touches on how the media hyped up a number of cases in the 1980s, despite the fact that the majority of patients had nonspecific symptoms and no abnormality in serological tests. Following this, the FDA mandated a moratorium in the 1990s severely limiting the use of silicone breast implants.  Clinical trials then followed, including one by MD Anderson Cancer Center which concluded no difference in the incidence of autoimmune-like disease between women with breast implants versus non-implant reconstruction.  After this, larger population-based analyses were performed and again showed no evidence of association between breast implants and a significant relative risk of individual connective tissue and autoimmune diseases.  In 2006, silicone implants were re-introduced to the US market with the stipulation that the manufacturers conduct large studies due to the lack of data.


Allergan and Mentor, two of the largest implant companies, performed a study with almost 100,000 women. Their findings showed a higher rate of Sjogren’s syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma when compared with normative data; however, this data was largely patient reported, and not standardized. Even though there was complete lack of causal evidence, this led to another rise in media attention and reigniting of the issue and therefore more studies. Of note, one recent study by Rohrich showed that there was statistically significant improvement in subjective health for patients who are distressed by their implants after removal.


The article concludes by suggesting a path forward due to the fact that the lack of robust epidemiologic evidence to support the association should not stop the pursuit of ongoing scientific evaluation and the key will be to figure out which patients benefit and why.  And although the relationship between breast implants and systemic disease, including autoimmune disease, has been postulated, studied, and claimed since the 1960s, no clear evidence exists, and the debate continues.


To change gears and discuss a different topic, textured breast implants have been correlated with a specific type of cancer called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).  Although this is still a correlation, the evidence is quite high for the association.  This cancer is typically diagnosed when a collection of fluid builds around the implant, often years later.  Research is currently ongoing trying to determine was the relationship and what the causal factor are.  Different theories exist ranging from bacteria to an inflammatory response to the texture itself and how it was made.  The prevalence of this cancer is very low, so at this time, I do not recommend electively removing implants when no other findings or symptoms exist. The good news is that we do not place textured implants at Cosmetic Surgery Affiliates anymore. 

To give a little back history, the textured implant became popularized after anatomically shaped implants were developed.  Instead of being perfectly round,  these implants were more of a tear drop shape.  The problem was that in some patients, the implant rotated after surgery, and the patient was left with a sideways breast.  Creating a textured implant made the implant “stick” to the tissue so it would not spin. After learning about the correlation with ALCL, the breast implant companies have since redirected back to the tried and true round implant, so it does not matter if it spins as it will retain the same shape.


Regardless of the lack of evidence showing any illness related to breast implants, many women find themselves desiring to have their implants removed.  The surgery required to remove the implant is very simple and takes very little time. An incision can be made in the same scar that was used to place the implant, and the implant is easily removed. 


The surgery becomes more complicated if excessive scar tissue exists. The body normally forms a scar around the implant called a capsule. In some patients, excessive scar tissue forms which can start to shrink down around the implant and make it feel hard; this is called a capsular contracture.  When the scar is soft, it can be left in place; however, when a thickened, hard capsule exists, I recommend removing it as well.  After the implant is removed, the previous pocket remains, and the empty space can collect fluid.  For this reason, I will often leave a drain for a couple days to prevent the formation the collection bodily fluids.


I always discuss the patient’s goals during consultation.  If implant removal is the only goal then, that is what is performed.  However, if the patient has concerns about feeling deflated or saggy after the implant is removed, then we discuss other options.  One option is to restore some of the volume with fat transfer to the breasts.  In essence, rearranging one’s own inventory by taking from on area such as the abdomen and then placing it in the breasts.  Another option for those who do not want the size anymore but want to be perkier, is a breast lift or mastopexy.  In this surgery, the nipple and areola stay attached but the hanging skin and glad are removed and the breast can be lifted back up to its previous location.  Many options exist, and Cosmetic Surgery Affiliates offers complimentary consultations in order to understand the patient’s goals, so that decisions can be made together.


The question over the safety of breast implants has recently surged in the media. What is interesting is that is a debate that has been going since the 1960s, but generally speaking, there are two main categories of implant related disease: Breast Implant Illness (BII) and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL).  Cutting to the chase, there are certain types of implants from which to stay away, but by and large I believe they are safe; however, some patients may choose to have their removed for a variety of reasons. 


Breast Implant Illness is a large, all-encompassing term that attempts to correlate vague, generalized symptoms into one diagnosis.  The Journal of Plastic and Reconstructive Surgery recently published an article called Breast Implant Illness, A Way Forward (Plastic and Reconstructive Surgery: March 2019 - Volume 143 - Issue 3S - p 74S–81S).  This article discusses that there have been a handful of cases reports dating from the 1960s of breast implants acting as a non-specific stimulant of the immune system. It then delves into the chemistry of silicone and discusses the difference of what is found in nature and what is in medical grade silicone.   It then touches on how the media hyped up a number of cases in the 1980s, despite the fact that the majority of patients had nonspecific symptoms and no abnormality in serological tests. Following this, the FDA mandated a moratorium in the 1990s severely limiting the use of silicone breast implants.  Clinical trials then followed, including one by MD Anderson Cancer Center which concluded no difference in the incidence of autoimmune-like disease between women with breast implants versus non-implant reconstruction.  After this, larger population-based analyses were performed and again showed no evidence of association between breast implants and a significant relative risk of individual connective tissue and autoimmune diseases.  In 2006, silicone implants were re-introduced to the US market with the stipulation that the manufacturers conduct large studies due to the lack of data.


Allergan and Mentor, two of the largest implant companies, performed a study with almost 100,000 women. Their findings showed a higher rate of Sjogren’s syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma when compared with normative data; however, this data was largely patient reported, and not standardized. Even though there was complete lack of causal evidence, this led to another rise in media attention and reigniting of the issue and therefore more studies. Of note, one recent study by Rohrich showed that there was statistically significant improvement in subjective health for patients who are distressed by their implants after removal.


The article concludes by suggesting a path forward due to the fact that the lack of robust epidemiologic evidence to support the association should not stop the pursuit of ongoing scientific evaluation and the key will be to figure out which patients benefit and why.  And although the relationship between breast implants and systemic disease, including autoimmune disease, has been postulated, studied, and claimed since the 1960s, no clear evidence exists, and the debate continues.


To change gears and discuss a different topic, textured breast implants have been correlated with a specific type of cancer called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).  Although this is still a correlation, the evidence is quite high for the association.  This cancer is typically diagnosed when a collection of fluid builds around the implant, often years later.  Research is currently ongoing trying to determine was the relationship and what the causal factor are.  Different theories exist ranging from bacteria to an inflammatory response to the texture itself and how it was made.  The prevalence of this cancer is very low, so at this time, I do not recommend electively removing implants when no other findings or symptoms exist. The good news is that we do not place textured implants at Cosmetic Surgery Affiliates anymore. 

To give a little back history, the textured implant became popularized after anatomically shaped implants were developed.  Instead of being perfectly round,  these implants were more of a tear drop shape.  The problem was that in some patients, the implant rotated after surgery, and the patient was left with a sideways breast.  Creating a textured implant made the implant “stick” to the tissue so it would not spin. After learning about the correlation with ALCL, the breast implant companies have since redirected back to the tried and true round implant, so it does not matter if it spins as it will retain the same shape.


Regardless of the lack of evidence showing any illness related to breast implants, many women find themselves desiring to have their implants removed.  The surgery required to remove the implant is very simple and takes very little time. An incision can be made in the same scar that was used to place the implant, and the implant is easily removed. 


The surgery becomes more complicated if excessive scar tissue exists. The body normally forms a scar around the implant called a capsule. In some patients, excessive scar tissue forms which can start to shrink down around the implant and make it feel hard; this is called a capsular contracture.  When the scar is soft, it can be left in place; however, when a thickened, hard capsule exists, I recommend removing it as well.  After the implant is removed, the previous pocket remains, and the empty space can collect fluid.  For this reason, I will often leave a drain for a couple days to prevent the formation the collection bodily fluids.


I always discuss the patient’s goals during consultation.  If implant removal is the only goal then, that is what is performed.  However, if the patient has concerns about feeling deflated or saggy after the implant is removed, then we discuss other options.  One option is to restore some of the volume with fat transfer to the breasts.  In essence, rearranging one’s own inventory by taking from on area such as the abdomen and then placing it in the breasts.  Another option for those who do not want the size anymore but want to be perkier, is a breast lift or mastopexy.  In this surgery, the nipple and areola stay attached but the hanging skin and glad are removed and the breast can be lifted back up to its previous location.  Many options exist, and Cosmetic Surgery Affiliates offers complimentary consultations in order to understand the patient’s goals, so that decisions can be made together.


The question over the safety of breast implants has recently surged in the media. What is interesting is that is a debate that has been going since the 1960s, but generally speaking, there are two main categories of implant related disease: Breast Implant Illness (BII) and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL).  Cutting to the chase, there are certain types of implants from which to stay away, but by and large I believe they are safe; however, some patients may choose to have their removed for a variety of reasons. 


Breast Implant Illness is a large, all-encompassing term that attempts to correlate vague, generalized symptoms into one diagnosis.  The Journal of Plastic and Reconstructive Surgery recently published an article called Breast Implant Illness, A Way Forward (Plastic and Reconstructive Surgery: March 2019 - Volume 143 - Issue 3S - p 74S–81S).  This article discusses that there have been a handful of cases reports dating from the 1960s of breast implants acting as a non-specific stimulant of the immune system. It then delves into the chemistry of silicone and discusses the difference of what is found in nature and what is in medical grade silicone.   It then touches on how the media hyped up a number of cases in the 1980s, despite the fact that the majority of patients had nonspecific symptoms and no abnormality in serological tests. Following this, the FDA mandated a moratorium in the 1990s severely limiting the use of silicone breast implants.  Clinical trials then followed, including one by MD Anderson Cancer Center which concluded no difference in the incidence of autoimmune-like disease between women with breast implants versus non-implant reconstruction.  After this, larger population-based analyses were performed and again showed no evidence of association between breast implants and a significant relative risk of individual connective tissue and autoimmune diseases.  In 2006, silicone implants were re-introduced to the US market with the stipulation that the manufacturers conduct large studies due to the lack of data.


Allergan and Mentor, two of the largest implant companies, performed a study with almost 100,000 women. Their findings showed a higher rate of Sjogren’s syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma when compared with normative data; however, this data was largely patient reported, and not standardized. Even though there was complete lack of causal evidence, this led to another rise in media attention and reigniting of the issue and therefore more studies. Of note, one recent study by Rohrich showed that there was statistically significant improvement in subjective health for patients who are distressed by their implants after removal.


The article concludes by suggesting a path forward due to the fact that the lack of robust epidemiologic evidence to support the association should not stop the pursuit of ongoing scientific evaluation and the key will be to figure out which patients benefit and why.  And although the relationship between breast implants and systemic disease, including autoimmune disease, has been postulated, studied, and claimed since the 1960s, no clear evidence exists, and the debate continues.


To change gears and discuss a different topic, textured breast implants have been correlated with a specific type of cancer called breast implant–associated anaplastic large cell lymphoma (BIA-ALCL).  Although this is still a correlation, the evidence is quite high for the association.  This cancer is typically diagnosed when a collection of fluid builds around the implant, often years later.  Research is currently ongoing trying to determine was the relationship and what the causal factor are.  Different theories exist ranging from bacteria to an inflammatory response to the texture itself and how it was made.  The prevalence of this cancer is very low, so at this time, I do not recommend electively removing implants when no other findings or symptoms exist. The good news is that we do not place textured implants at Cosmetic Surgery Affiliates anymore. 

To give a little back history, the textured implant became popularized after anatomically shaped implants were developed.  Instead of being perfectly round,  these implants were more of a tear drop shape.  The problem was that in some patients, the implant rotated after surgery, and the patient was left with a sideways breast.  Creating a textured implant made the implant “stick” to the tissue so it would not spin. After learning about the correlation with ALCL, the breast implant companies have since redirected back to the tried and true round implant, so it does not matter if it spins as it will retain the same shape.


Regardless of the lack of evidence showing any illness related to breast implants, many women find themselves desiring to have their implants removed.  The surgery required to remove the implant is very simple and takes very little time. An incision can be made in the same scar that was used to place the implant, and the implant is easily removed. 


The surgery becomes more complicated if excessive scar tissue exists. The body normally forms a scar around the implant called a capsule. In some patients, excessive scar tissue forms which can start to shrink down around the implant and make it feel hard; this is called a capsular contracture.  When the scar is soft, it can be left in place; however, when a thickened, hard capsule exists, I recommend removing it as well.  After the implant is removed, the previous pocket remains, and the empty space can collect fluid.  For this reason, I will often leave a drain for a couple days to prevent the formation the collection bodily fluids.


I always discuss the patient’s goals during consultation.  If implant removal is the only goal then, that is what is performed.  However, if the patient has concerns about feeling deflated or saggy after the implant is removed, then we discuss other options.  One option is to restore some of the volume with fat transfer to the breasts.  In essence, rearranging one’s own inventory by taking from on area such as the abdomen and then placing it in the breasts.  Another option for those who do not want the size anymore but want to be perkier, is a breast lift or mastopexy.  In this surgery, the nipple and areola stay attached but the hanging skin and glad are removed and the breast can be lifted back up to its previous location.  Many options exist, and Cosmetic Surgery Affiliates offers complimentary consultations in order to understand the patient’s goals, so that decisions can be made together.


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