ilena

http://www.breastimplantinfo.org/news/clinicaldata.htm

Symptoms and Complications from Silicone Gel Breast Implants

FDA's October 2003 Summary of Research on Inamed Implants

Panelist Quotes I Panel Vote

By Diana Zuckerman, Ph.D., Elizabeth Santoro, R.N., M.P.H., and Nicole
Hudak

On October 14-15, 2003, the FDA held a public meeting to discuss
Inamed's new research on their silicone gel implants. The company is
asking the FDA to approve their implants as safe and effective, but
the company's own research shows substantial complication rates and
worrisome increases in symptoms for women using their implants. This
issue brief is based on the FDA's analysis of the research by Inamed.

Complications Experienced by Augmentation Patients within Three Years

There were 494 augmentation patients enrolled in Inamed's "core study"
of silicone breast implants. Ninety percent of these 494 patients
participated in follow-up after two years, and 81% completed follow-up
after three years.

Complications within 3 Years Rate
Re-operation 21%
Capsular Contracture (Baker's III/IV)* 8%
Scarring 8%
Implant Removal/Replacement 8%
Breast Pain 6%
Nipple Sensation Change 3%
Implant Rupture 1%
Infection 1%

Source: FDA's slide # 39

* Baker III or IV capsular contracture is a painful condition where
scar tissue around the implant tightens, thus causing the breast to
become firm, hard, and distorted.

Health Symptoms Reported by Augmentation Patients

The augmentation patients in the "core study" were asked about
numerous health symptoms both before they were implanted and after two
years with silicone gel breast implants. Overall, there were
substantial increases in the number of augmentation patients reporting
fatigue, pain, joint problems, and other symptoms -- in some cases,
the numbers tripled from before surgery to two years later.

Symptom Pre-Implant 2 Year Follow-Up
Muscle Symptoms 75 (20%) 108 (28%)
Joint Symptoms 50 (13%) 85 (22%)
Neurological Symptoms 158 (41%) 180 (47%)
Muscle Pain 34 (9%) 57 (15%)
Joint Pain 10 (3%) 26 (7%)
Morning Stiffness 39 (10%) 70 (18%)
Fatigue 33 (9%) 101 (26%)
Generalized Pain 8 (2%) 19 (5%)

Source: FDA's slide # 45

Complications Experienced by Reconstruction Patients within Three
Years

There were 221 breast cancer reconstruction patients enrolled in the
"core study" of silicone gel breast implants. Ninety-five percent of
these 221 patients participated in follow-up after two years but many
had not yet completed three years when the analyses were completed.

Complications Within 3 Years Rate
Re-operation 46%
Implant Removal/Replacement 25%
Capsular Contracture (Baker's III/IV)* 16%
Implant Rupture 6%
Tissue/Skin Necrosis** 6%
Breast Pain 6%
Scarring 6%
Infection 2%

Source: FDA's slide # 49

* Baker III or IV capsular contracture is a painful condition where
scar tissue around the implant tightens, thus causing the breast to
become firm, hard, and distorted.

** Necrosis is a painful and disfiguring condition where the skin or
tissue dies

Health Symptoms Reported by Reconstruction Patients

The reconstruction patients in the "core study" were asked about
numerous health symptoms both before they were implanted, and after
two years with silicone gel breast implants. Overall, there were
substantial increases in the number of reconstruction patients
reporting joint pain, neurological symptoms, hair loss, rashes, and
morning stiffness.

Symptom Pre-Implant 2 Year Follow-Up
Skin Symptoms Including Rashes and Hair Loss 20 (12%) 35 (22%)
Muscle Symptoms 56 (35%) 65 (40%)
Joint Symptoms 69 (43%) 94 (60%)
Neurological Symptoms 78 (48%) 97 (60%)
Joint Pain 17 (11%) 31 (19%)
Morning Stiffness 39 (10%) 70 (18%)

Source: FDA's slide # 55

Complications Experienced by Revision Patients after Three years

There were 225 revision patients enrolled in the "core study" of
silicone gel breast implants. These women had new breast implants that
replaced problem implants, and their complication rate was generally
higher than augmentation patients but lower than reconstruction
patients. Eighty-seven percent of these 225 patients participated in
follow-up after two years, and 83% completed follow-up after three
years.

Complications within 3 Years Rate
Re-operation 33%
Removal/ Replacement 13%
Capsular Contracture* (Baker's III/ IV) 10%
Scarring 9%
Breast Pain 7%
Wrinkling/ Ripping 5%
Implant Rupture 4%
Infection 3%

Source: FDA's slide # 59

* Baker III or IV capsular contracture is a painful condition where
scar tissue around the implant tightens, thus causing the breast to
become firm, hard, and distorted.

Health Symptoms Reported by Revision Patients

The revision patients in the "core study" were asked about numerous
health symptoms both before and after they were implanted, and after
two years with silicone gel breast implants. Overall, there were
substantial increases in the number of revision patients reporting
skin, muscle, joint, and neurological symptoms.

Sign/Symptom Pre-Implant 2 Year Follow-Up
Skin (rashes, hair loss, etc) 13 (8%) 24 (15%)
Muscle 46 (29%) 62 (40%)
Joint 41 (26%) 56 (36%)
Neurological 59 (38%) 78 (50%)
General 55 (35%) 66 (42%)

Source: FDA's slide #65

Key Points to Summarize Complications and Symptoms

The most frequent complication is re-operation, which means that most
women getting breast implants will require more than one surgery and
additional visits to the doctor.
Most implants are removed to treat complications. The most frequent
reason for re-operation is for capsular contracture, which is the most
common complication and can be painful and disfiguring.
Autoimmune disease signs & symptoms increase over time.
Source: FDA's slide # 69

Do Breast Implants Improve Quality of Life?

Inamed also used several measures of health and mental health to
evaluate implant patients' quality of life before and after receiving
breast implants. On average, women reported poorer health or mental
health after implants compared to before.

Almost every measure of emotional and physical health, including
social relationships and self-esteem, declined after getting breast
implants. The only improvements were in self-reported sexual
attractiveness.
Most patients who were studied two years after getting implants
reported being satisfied with their silicone breast implants. However,
they were more satisfied immediately after getting implants than they
were two years later.

ooreroom

Another good one. Bravo, Old Girl!
That's not so hard, is it?

rogene

http://www.breastimplantinfo.org/news/clinicaldata.htm

Symptoms and Complications from Silicone Gel Breast Implants

FDA’s October 2003 Summary of Research on Inamed Implants

Panelist Quotes I Panel Vote

By Diana Zuckerman, Ph.D., Elizabeth Santoro, R.N., M.P.H., and Nicole Hudak

On October 14-15, 2003, the FDA held a public meeting to discuss Inamed’s
new research on their silicone gel implants. The company is asking the FDA
to approve their implants as safe and effective, but the company’s own
research shows substantial complication rates and worrisome increases in
symptoms for women using their implants. This issue brief is based on the
FDA’s analysis of the research by Inamed.

Complications Experienced by Augmentation Patients within Three Years

There were 494 augmentation patients enrolled in Inamed’s "core study" of
silicone breast implants. Ninety percent of these 494 patients participated
in follow-up after two years, and 81% completed follow-up after three years.

Complications within 3 Years Rate
Re-operation 21%
Capsular Contracture (Baker’s III/IV)* 8%
Scarring 8%
Implant Removal/Replacement 8%
Breast Pain 6%
Nipple Sensation Change 3%
Implant Rupture 1%
Infection 1%

Source: FDA’s slide # 39

* Baker III or IV capsular contracture is a painful condition where scar
tissue around the implant tightens, thus causing the breast to become firm,
hard, and distorted.

Health Symptoms Reported by Augmentation Patients

The augmentation patients in the "core study" were asked about numerous
health symptoms both before they were implanted and after two years with
silicone gel breast implants. Overall, there were substantial increases in
the number of augmentation patients reporting fatigue, pain, joint problems,
and other symptoms -- in some cases, the numbers tripled from before surgery
to two years later.

Symptom Pre-Implant 2 Year Follow-Up
Muscle Symptoms 75 (20%) 108 (28%)
Joint Symptoms 50 (13%) 85 (22%)
Neurological Symptoms 158 (41%) 180 (47%)
Muscle Pain 34 (9%) 57 (15%)
Joint Pain 10 (3%) 26 (7%)
Morning Stiffness 39 (10%) 70 (18%)
Fatigue 33 (9%) 101 (26%)
Generalized Pain 8 (2%) 19 (5%)

Source: FDA’s slide # 45

Complications Experienced by Reconstruction Patients within Three Years

There were 221 breast cancer reconstruction patients enrolled in the "core
study" of silicone gel breast implants. Ninety-five percent of these 221
patients participated in follow-up after two years but many had not yet
completed three years when the analyses were completed.

Complications Within 3 Years Rate
Re-operation 46%
Implant Removal/Replacement 25%
Capsular Contracture (Baker’s III/IV)* 16%
Implant Rupture 6%
Tissue/Skin Necrosis** 6%
Breast Pain 6%
Scarring 6%
Infection 2%

Source: FDA’s slide # 49

* Baker III or IV capsular contracture is a painful condition where scar
tissue around the implant tightens, thus causing the breast to become firm,
hard, and distorted.

** Necrosis is a painful and disfiguring condition where the skin or tissue
dies


Health Symptoms Reported by Reconstruction Patients

The reconstruction patients in the "core study" were asked about numerous
health symptoms both before they were implanted, and after two years with
silicone gel breast implants. Overall, there were substantial increases in
the number of reconstruction patients reporting joint pain, neurological
symptoms, hair loss, rashes, and morning stiffness.

Symptom Pre-Implant 2
Year Follow-Up
Skin Symptoms Including Rashes and Hair Loss 20 (12%) 35 (22%)
Muscle Symptoms 56 (35%) 65
(40%)
Joint Symptoms 69 (43%)
94 (60%)
Neurological Symptoms 78 (48%) 97
(60%)
Joint Pain 17 (11%)
31 (19%)
Morning Stiffness 39 (10%)
70 (18%)

Source: FDA’s slide # 55

Complications Experienced by Revision Patients after Three years

There were 225 revision patients enrolled in the "core study" of silicone
gel breast implants. These women had new breast implants that replaced
problem implants, and their complication rate was generally higher than
augmentation patients but lower than reconstruction patients. Eighty-seven
percent of these 225 patients participated in follow-up after two years, and
83% completed follow-up after three years.

Complications within 3 Years Rate
Re-operation 33%
Removal/ Replacement 13%
Capsular Contracture* (Baker’s III/ IV) 10%
Scarring 9%
Breast Pain 7%
Wrinkling/ Ripping 5%
Implant Rupture 4%
Infection 3%

Source: FDA’s slide # 59

* Baker III or IV capsular contracture is a painful condition where scar
tissue around the implant tightens, thus causing the breast to become firm,
hard, and distorted.

Health Symptoms Reported by Revision Patients

The revision patients in the "core study" were asked about numerous health
symptoms both before and after they were implanted, and after two years with
silicone gel breast implants. Overall, there were substantial increases in
the number of revision patients reporting skin, muscle, joint, and
neurological symptoms.

Sign/Symptom Pre-Implant 2 Year Follow-Up
Skin (rashes, hair loss, etc) 13 (8%) 24 (15%)
Muscle 46 (29%) 62 (40%)
Joint 41 (26%) 56 (36%)
Neurological 59 (38%) 78 (50%)
General 55 (35%) 66 (42%)

Source: FDA’s slide #65

Key Points to Summarize Complications and Symptoms

The most frequent complication is re-operation, which means that most women
getting breast implants will require more than one surgery and additional
visits to the doctor.

Most implants are removed to treat complications. The most frequent reason
for re-operation is for capsular contracture, which is the most common
complication and can be painful and disfiguring.

Autoimmune disease signs & symptoms increase over time.

Source: FDA’s slide # 69

Do Breast Implants Improve Quality of Life?

Inamed also used several measures of health and mental health to evaluate
implant patients’ quality of life before and after receiving breast
implants. On average, women reported poorer health or mental health after
implants compared to before.

Almost every measure of emotional and physical health, including social
relationships and self-esteem, declined after getting breast implants. The
only improvements were in self-reported sexual attractiveness.

Most patients who were studied two years after getting implants reported
being satisfied with their silicone breast implants. However, they were more
satisfied immediately after getting implants than they were two years later.