ilena

http://www.humanticsfoundation.com/2003canadianstudy.htm


November, 2003

Health Complications from Breast Implant Surgery:

A Canadian Study with Implications for the U.S.

By Aleina Tweed, British Columbia Centre of Excellence for Women's Health

For decades, women who have undergone breast implant surgery have reported high
implant failure rates and unidentifiable illnesses. In 1992, silicone
gel-filled implants were subject to government moratoriums in the United States
and in Canada, until such time as their safety could be assured. In the years
that have followed, researchers have tried to find answers. In the meantime,
breast implantation continues to become more and more popular, with
saline-filled implants taking the place of their silicone predecessors.

In Canada and the United States, approximately 20% of implant surgeries are for
reconstruction, primarily after cancer or prophylactic mastectomy, and 80% are
cosmetic augmentation. Such surgery is not considered medically necessary and
is therefore paid for privately. However, when there are health consequences
of this surgery – whether local complications or controversial systemic
complications – Canadian women enter the public health care system for their
care.

High complication rates have been well-do***ented. A Mayo Clinic study in the
United States, for example, found that 25% of women with breast implants
suffered local complications requiring additional surgery within five years.
Studies by implant manufacturers in the U.S. have reported that most
reconstruction patients and a large proportion of augmentation patients report
at least one serious complication within three years. In addition, there were
103,343 adverse reaction reports regarding silicone breast implants and 23,454
reports for saline implants received by the U.S. Food and Drug Administration
between 1985 and 1996.

A new study by researchers at the Centre of Excellence for Women's Health in
British Columbia finds relatively high complication rates for breast
implantation in Canada as well. Data collected from a study group of 147 women
who had undergone breast implant surgery were compared to data from a
non-implant comparison group (583 women). The study reported that women who
have or have had breast implants:

Ø visited doctors and specialists significantly more often

Ø were more than four times as likely to be hospitalized, and

Ø experienced more hospitalizations over the study period than women
without implants.

All these differences were significant when age, marital status, education
level, exercise, use of alcohol, and geographic region were statistically
controlled. Types of implants (saline or silicone gel) did not significantly
affect hospitalization or medical utilization.

The study also found that over half (51%) of respondents from the study group
reported at least one additional breast-implant related surgery subsequent to
the initial implantation. Of those, half (49%) had undergone one additional
surgery, 23% had undergone two, 11% had undergone three, and 17% had undergone
four or more additional surgeries. For some of these women, the complications
were enough to convince them that they no longer wanted breast implants. Forty
percent of respondents had had their implants permanently removed.

One-third of the women in the study had implants for less than 10 years (some
for just a few months) and 42% had implants for 11-20 years. Compared to most
other studies, these women had implants for a longer period of time. Although
more than two out of three (71%) reported their health as good or excellent,
half had been diagnosed with at least one chronic illness, one in three had
quit their job or reduced their work hours because of health problems, and more
than half had problems doing housework or recreational activities because of
health problems.

Breast implant surgery is not deemed medically necessary and is performed –
and paid for – privately in the vast majority of cases. However, it appears
to directly contribute to an increased need for public health care services
among the women receiving these devices. If, as the literature suggests,
serious local complication rates are at least 25% – and more likely are 50%
or higher – there are many thousands of women in Canada and the U.S. who are
using greater health care resources as a result of this surgery, and whose
health and well-being may be at risk.

Complications with Breast Implantation
There are three major groups of health complications associated with breast
implants: local complications, systemic complications and psychological
complications. Breast implant surgery also carries the same risks associated
with any surgical implantation of a medical device. All aesthetic complications
(dissatisfaction with size, position, etc., of the implants) are not funded by
public health care; however, in Canada all health complications resulting from
the implant, including the removal of the implants, are covered by publicly
funded health care. In the U.S., most of the medical care caused by these
complications must be paid for by the woman herself.

1. Surgical complications
Any surgery – and breast implantation is no different – involves risks such
as complications of general anesthesia, infection, haematoma, hemorrhage,
thrombosis, skin necrosis, delayed wound healing and additional surgeries.

Most women with breast implants will require additional surgery or surgeries
related to their implants. These procedures may include treatment of capsular
contracture, correction of the implant's size or position, infection control
as the result of other local or systemic complications, or to prevent or treat
leakage, rupture or other health problems.

2. Local complications
Local complications can range from very mild to very severe, and they affect a
large percentage of women who undergo breast implant surgery. Capsular
contracture is one of the most common; contraction of the wall of scar tissue
surrounding the breast implant may cause hardness of the breast, discomfort and
even severe pain. According to Health Canada, capsular contracture occurs,
usually within two years of surgery, in approximately 25% of women who undergo
breast implant surgery. Other researchers suggest the percentage is as high as
70%.

Implant deflation and rupture caused by normal deterioration over time, breast
trauma, undetected damage or shell weakness in the implant are significant
complications; one study found that 70% of removed implants 11 to 15 years old
were ruptured or leaking. In a study by the U.S. FDA, two-thirds of 344
implanted women examined with MRI had ruptured implants. Deflation, leakage and
rupture can result in the breast implant filling being spread through the body.
When the filling is silicone gel, the silicone can migrate to other parts of
the body and be difficult or impossible to remove.

Other complications include change in shape or volume of the breast; change in
breast sensation; calcium deposits; mammographic interference, and breast/chest
discomfort or pain and nipple discharge.

3. Systemic complications
Systemic complications appear most frequently several years after breast
implantation. These complications tend to present as a cluster of symptoms,
including those associated with autoimmune diseases, connective tissue
diseases, "human adjuvant disease" and/or fibrositis/fibromyalgia-like
disorders. (The classic autoimmune and connective tissue diseases thought to be
associated with silicone implants are scleroderma, lupus, mixed connective
tissue disease, rheumatoid arthritis and Sjogren-Larsson syndrome.) Women with
breast implants have also reported granulomas and lymph node involvement,
chronic flu, respiratory problems and infections. Cancer also remains a
concern; a study by the National Cancer Institute found women with breast
implants were more likely to die from brain cancer or lung cancer compared to
other plastic surgery patients.

The link between breast implants and systemic complications is still not
clearly understood. Epidemiologic research has not been conducted on large
numbers of women who had implants for at least ten years, which would be a
reasonable period of time to determine the health risks.

4. Psychological consequences
Unfortunately, studies of the psychological consequences of breast augmentation
have been largely anecdotal, consisting primarily of surgeons' reports of
their patients' satisfaction. These reports suggest that typically 70% or
more of patients report satisfaction with their surgical outcome. However, such
investigations clearly have serious problems. How many patients will admit,
face-to-face with their surgeon, that they are not satisfied with the results
of their surgery? How many surgeons will admit that their patients are not
satisfied?

Many studies suggest that cosmetic surgery in general leads to immediate
post-operative improvements in body image, quality of life and depressive
symptoms. However, the FDA pointed out at their October 14 public meeting that
the Inamed studies found a decline in most mental health and quality of life
measures two years after getting breast implants, compared to before
implantation. Those findings were consistent for augmentation or
reconstruction patients. Other studies have found that women who have their
breast implants removed without replacement report higher levels of breast
anxiety, upper torso dissatisfaction and depression both before and after
implant removal, compared to women who have undergone other cosmetic surgery
and women who have not undergone any cosmetic surgery. Since many women have
their breast implants removed, these findings suggest that breast implant
surgery leads to poorer psychological well-being, rather than better, for many
women.

~~~~~~~~~~

http://www.BreastImplantAwareness.org

ooreroom

November, 2003

Health Complications from Breast Implant Surgery:

A Canadian Study with Implications for the U.S.

By Aleina Tweed, British Columbia Centre of Excellence for Women’s Health

For decades, women who have undergone breast implant surgery have reported high
implant failure rates and unidentifiable illnesses. In 1992, silicone
gel-filled implants were subject to government moratoriums in the United States
and in Canada, until such time as their safety could be assured. In the years
that have followed, researchers have tried to find answers. In the meantime,
breast implantation continues to become more and more popular, with
saline-filled implants taking the place of their silicone predecessors.

In Canada and the United States, approximately 20% of implant surgeries are for
reconstruction, primarily after cancer or prophylactic mastectomy, and 80% are
cosmetic augmentation. Such surgery is not considered medically necessary and
is therefore paid for privately. However, when there are health consequences
of this surgery – whether local complications or controversial systemic
complications – Canadian women enter the public health care system for their
care.

High complication rates have been well-do***ented. A Mayo Clinic study in the
United States, for example, found that 25% of women with breast implants
suffered local complications requiring additional surgery within five years.
Studies by implant manufacturers in the U.S. have reported that most
reconstruction patients and a large proportion of augmentation patients report
at least one serious complication within three years. In addition, there were
103,343 adverse reaction reports regarding silicone breast implants and 23,454
reports for saline implants received by the U.S. Food and Drug Administration
between 1985 and 1996.

A new study by researchers at the Centre of Excellence for Women’s Health in
British Columbia finds relatively high complication rates for breast
implantation in Canada as well. Data collected from a study group of 147 women
who had undergone breast implant surgery were compared to data from a
non-implant comparison group (583 women). The study reported that women who
have or have had breast implants:

Ø visited doctors and specialists significantly more often

Ø were more than four times as likely to be hospitalized, and

Ø experienced more hospitalizations over the study period than women
without implants.

All these differences were significant when age, marital status, education
level, exercise, use of alcohol, and geographic region were statistically
controlled. Types of implants (saline or silicone gel) did not significantly
affect hospitalization or medical utilization.

The study also found that over half (51%) of respondents from the study group
reported at least one additional breast-implant related surgery subsequent to
the initial implantation. Of those, half (49%) had undergone one additional
surgery, 23% had undergone two, 11% had undergone three, and 17% had undergone
four or more additional surgeries. For some of these women, the complications
were enough to convince them that they no longer wanted breast implants. Forty
percent of respondents had had their implants permanently removed.

One-third of the women in the study had implants for less than 10 years (some
for just a few months) and 42% had implants for 11-20 years. Compared to most
other studies, these women had implants for a longer period of time. Although
more than two out of three (71%) reported their health as good or excellent,
half had been diagnosed with at least one chronic illness, one in three had
quit their job or reduced their work hours because of health problems, and more
than half had problems doing housework or recreational activities because of
health problems.

Breast implant surgery is not deemed medically necessary and is performed –
and paid for – privately in the vast majority of cases. However, it appears
to directly contribute to an increased need for public health care services
among the women receiving these devices. If, as the literature suggests,
serious local complication rates are at least 25% – and more likely are 50%
or higher – there are many thousands of women in Canada and the U.S. who are
using greater health care resources as a result of this surgery, and whose
health and well-being may be at risk.

Complications with Breast Implantation
There are three major groups of health complications associated with breast
implants: local complications, systemic complications and psychological
complications. Breast implant surgery also carries the same risks associated
with any surgical implantation of a medical device. All aesthetic complications
(dissatisfaction with size, position, etc., of the implants) are not funded by
public health care; however, in Canada all health complications resulting from
the implant, including the removal of the implants, are covered by publicly
funded health care. In the U.S., most of the medical care caused by these
complications must be paid for by the woman herself.

1. Surgical complications
Any surgery – and breast implantation is no different – involves risks such
as complications of general anesthesia, infection, haematoma, hemorrhage,
thrombosis, skin necrosis, delayed wound healing and additional surgeries.

Most women with breast implants will require additional surgery or surgeries
related to their implants. These procedures may include treatment of capsular
contracture, correction of the implant’s size or position, infection control
as the result of other local or systemic complications, or to prevent or treat
leakage, rupture or other health problems.

2. Local complications
Local complications can range from very mild to very severe, and they affect a
large percentage of women who undergo breast implant surgery. Capsular
contracture is one of the most common; contraction of the wall of scar tissue
surrounding the breast implant may cause hardness of the breast, discomfort and
even severe pain. According to Health Canada, capsular contracture occurs,
usually within two years of surgery, in approximately 25% of women who undergo
breast implant surgery. Other researchers suggest the percentage is as high as
70%.

Implant deflation and rupture caused by normal deterioration over time, breast
trauma, undetected damage or shell weakness in the implant are significant
complications; one study found that 70% of removed implants 11 to 15 years old
were ruptured or leaking. In a study by the U.S. FDA, two-thirds of 344
implanted women examined with MRI had ruptured implants. Deflation, leakage and
rupture can result in the breast implant filling being spread through the body.
When the filling is silicone gel, the silicone can migrate to other parts of
the body and be difficult or impossible to remove.

Other complications include change in shape or volume of the breast; change in
breast sensation; calcium deposits; mammographic interference, and breast/chest
discomfort or pain and nipple discharge.

3. Systemic complications
Systemic complications appear most frequently several years after breast
implantation. These complications tend to present as a cluster of symptoms,
including those associated with autoimmune diseases, connective tissue
diseases, “human adjuvant disease� and/or fibrositis/fibromyalgia-like
disorders. (The classic autoimmune and connective tissue diseases thought to be
associated with silicone implants are scleroderma, lupus, mixed connective
tissue disease, rheumatoid arthritis and Sjogren-Larsson syndrome.) Women with
breast implants have also reported granulomas and lymph node involvement,
chronic flu, respiratory problems and infections. Cancer also remains a
concern; a study by the National Cancer Institute found women with breast
implants were more likely to die from brain cancer or lung cancer compared to
other plastic surgery patients.

The link between breast implants and systemic complications is still not
clearly understood. Epidemiologic research has not been conducted on large
numbers of women who had implants for at least ten years, which would be a
reasonable period of time to determine the health risks.

4. Psychological consequences
Unfortunately, studies of the psychological consequences of breast augmentation
have been largely anecdotal, consisting primarily of surgeons’ reports of
their patients’ satisfaction. These reports suggest that typically 70% or
more of patients report satisfaction with their surgical outcome. However, such
investigations clearly have serious problems. How many patients will admit,
face-to-face with their surgeon, that they are not satisfied with the results
of their surgery? How many surgeons will admit that their patients are not
satisfied?

Many studies suggest that cosmetic surgery in general leads to immediate
post-operative improvements in body image, quality of life and depressive
symptoms. However, the FDA pointed out at their October 14 public meeting that
the Inamed studies found a decline in most mental health and quality of life
measures two years after getting breast implants, compared to before
implantation. Those findings were consistent for augmentation or
reconstruction patients. Other studies have found that women who have their
breast implants removed without replacement report higher levels of breast
anxiety, upper torso dissatisfaction and depression both before and after
implant removal, compared to women who have undergone other cosmetic surgery
and women who have not undergone any cosmetic surgery. Since many women have
their breast implants removed, these findings suggest that breast implant
surgery leads to poorer psychological well-being, rather than better, for many
women.

ilena

http://www.humanticsfoundation.com/2003canadianstudy.htm


November, 2003

Health Complications from Breast Implant Surgery:

A Canadian Study with Implications for the U.S.

By Aleina Tweed, British Columbia Centre of Excellence for Women's Health

For decades, women who have undergone breast implant surgery have reported high
implant failure rates and unidentifiable illnesses. In 1992, silicone
gel-filled implants were subject to government moratoriums in the United States
and in Canada, until such time as their safety could be assured. In the years
that have followed, researchers have tried to find answers. In the meantime,
breast implantation continues to become more and more popular, with
saline-filled implants taking the place of their silicone predecessors.

In Canada and the United States, approximately 20% of implant surgeries are for
reconstruction, primarily after cancer or prophylactic mastectomy, and 80% are
cosmetic augmentation. Such surgery is not considered medically necessary and
is therefore paid for privately. However, when there are health consequences
of this surgery – whether local complications or controversial systemic
complications – Canadian women enter the public health care system for their
care.

High complication rates have been well-do***ented. A Mayo Clinic study in the
United States, for example, found that 25% of women with breast implants
suffered local complications requiring additional surgery within five years.
Studies by implant manufacturers in the U.S. have reported that most
reconstruction patients and a large proportion of augmentation patients report
at least one serious complication within three years. In addition, there were
103,343 adverse reaction reports regarding silicone breast implants and 23,454
reports for saline implants received by the U.S. Food and Drug Administration
between 1985 and 1996.

A new study by researchers at the Centre of Excellence for Women's Health in
British Columbia finds relatively high complication rates for breast
implantation in Canada as well. Data collected from a study group of 147 women
who had undergone breast implant surgery were compared to data from a
non-implant comparison group (583 women). The study reported that women who
have or have had breast implants:

Ø visited doctors and specialists significantly more often

Ø were more than four times as likely to be hospitalized, and

Ø experienced more hospitalizations over the study period than women
without implants.

All these differences were significant when age, marital status, education
level, exercise, use of alcohol, and geographic region were statistically
controlled. Types of implants (saline or silicone gel) did not significantly
affect hospitalization or medical utilization.

The study also found that over half (51%) of respondents from the study group
reported at least one additional breast-implant related surgery subsequent to
the initial implantation. Of those, half (49%) had undergone one additional
surgery, 23% had undergone two, 11% had undergone three, and 17% had undergone
four or more additional surgeries. For some of these women, the complications
were enough to convince them that they no longer wanted breast implants. Forty
percent of respondents had had their implants permanently removed.

One-third of the women in the study had implants for less than 10 years (some
for just a few months) and 42% had implants for 11-20 years. Compared to most
other studies, these women had implants for a longer period of time. Although
more than two out of three (71%) reported their health as good or excellent,
half had been diagnosed with at least one chronic illness, one in three had
quit their job or reduced their work hours because of health problems, and more
than half had problems doing housework or recreational activities because of
health problems.

Breast implant surgery is not deemed medically necessary and is performed –
and paid for – privately in the vast majority of cases. However, it appears
to directly contribute to an increased need for public health care services
among the women receiving these devices. If, as the literature suggests,
serious local complication rates are at least 25% – and more likely are 50%
or higher – there are many thousands of women in Canada and the U.S. who are
using greater health care resources as a result of this surgery, and whose
health and well-being may be at risk.

Complications with Breast Implantation
There are three major groups of health complications associated with breast
implants: local complications, systemic complications and psychological
complications. Breast implant surgery also carries the same risks associated
with any surgical implantation of a medical device. All aesthetic complications
(dissatisfaction with size, position, etc., of the implants) are not funded by
public health care; however, in Canada all health complications resulting from
the implant, including the removal of the implants, are covered by publicly
funded health care. In the U.S., most of the medical care caused by these
complications must be paid for by the woman herself.

1. Surgical complications
Any surgery – and breast implantation is no different – involves risks such
as complications of general anesthesia, infection, haematoma, hemorrhage,
thrombosis, skin necrosis, delayed wound healing and additional surgeries.

Most women with breast implants will require additional surgery or surgeries
related to their implants. These procedures may include treatment of capsular
contracture, correction of the implant's size or position, infection control
as the result of other local or systemic complications, or to prevent or treat
leakage, rupture or other health problems.

2. Local complications
Local complications can range from very mild to very severe, and they affect a
large percentage of women who undergo breast implant surgery. Capsular
contracture is one of the most common; contraction of the wall of scar tissue
surrounding the breast implant may cause hardness of the breast, discomfort and
even severe pain. According to Health Canada, capsular contracture occurs,
usually within two years of surgery, in approximately 25% of women who undergo
breast implant surgery. Other researchers suggest the percentage is as high as
70%.

Implant deflation and rupture caused by normal deterioration over time, breast
trauma, undetected damage or shell weakness in the implant are significant
complications; one study found that 70% of removed implants 11 to 15 years old
were ruptured or leaking. In a study by the U.S. FDA, two-thirds of 344
implanted women examined with MRI had ruptured implants. Deflation, leakage and
rupture can result in the breast implant filling being spread through the body.
When the filling is silicone gel, the silicone can migrate to other parts of
the body and be difficult or impossible to remove.

Other complications include change in shape or volume of the breast; change in
breast sensation; calcium deposits; mammographic interference, and breast/chest
discomfort or pain and nipple discharge.

3. Systemic complications
Systemic complications appear most frequently several years after breast
implantation. These complications tend to present as a cluster of symptoms,
including those associated with autoimmune diseases, connective tissue
diseases, "human adjuvant disease" and/or fibrositis/fibromyalgia-like
disorders. (The classic autoimmune and connective tissue diseases thought to be
associated with silicone implants are scleroderma, lupus, mixed connective
tissue disease, rheumatoid arthritis and Sjogren-Larsson syndrome.) Women with
breast implants have also reported granulomas and lymph node involvement,
chronic flu, respiratory problems and infections. Cancer also remains a
concern; a study by the National Cancer Institute found women with breast
implants were more likely to die from brain cancer or lung cancer compared to
other plastic surgery patients.

The link between breast implants and systemic complications is still not
clearly understood. Epidemiologic research has not been conducted on large
numbers of women who had implants for at least ten years, which would be a
reasonable period of time to determine the health risks.

4. Psychological consequences
Unfortunately, studies of the psychological consequences of breast augmentation
have been largely anecdotal, consisting primarily of surgeons' reports of
their patients' satisfaction. These reports suggest that typically 70% or
more of patients report satisfaction with their surgical outcome. However, such
investigations clearly have serious problems. How many patients will admit,
face-to-face with their surgeon, that they are not satisfied with the results
of their surgery? How many surgeons will admit that their patients are not
satisfied?

Many studies suggest that cosmetic surgery in general leads to immediate
post-operative improvements in body image, quality of life and depressive
symptoms. However, the FDA pointed out at their October 14 public meeting that
the Inamed studies found a decline in most mental health and quality of life
measures two years after getting breast implants, compared to before
implantation. Those findings were consistent for augmentation or
reconstruction patients. Other studies have found that women who have their
breast implants removed without replacement report higher levels of breast
anxiety, upper torso dissatisfaction and depression both before and after
implant removal, compared to women who have undergone other cosmetic surgery
and women who have not undergone any cosmetic surgery. Since many women have
their breast implants removed, these findings suggest that breast implant
surgery leads to poorer psychological well-being, rather than better, for many
women.

~~~~~~~~~~

http://www.BreastImplantAwareness.org