Symptoms and Complications from Silicone Gel Breast Implants FDA’s October 2003 Summary of Research on Inamed Implants

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.