My name is Janet. In view of all the questions being raised on the safety at breast implants at this time, I would like to talk you about my daughter, Jana.

My daughter decided to have breast augmentation surgery for reasons she described, "so that my clothes will fit better and to help improve my self esteem." I did tell her that I was opposed to her having this surgery for those reasons but that I would support her decision if that was what she decided to do. We discussed the saline versus silicone implants and I did ask her to please have saline implants just on the chance that they might rupture. She agreed to do this.

Following her consultative visit with a plastic surgeon of her choice, she discussed with me what she had been told by the plastic surgeon. She said, "I am having silicone jel implants with a textured silicone covering because the surgeon said that the chances of complications and contractures are less likely to occur with this type of implant as compared to saline implants". She, indeed, did undergo the implant surgery as planned.

The augmentation surgery and recovery period were uneventful.

Prior to her surgery, and for nine (9) months following, my daughter had no major health problems that I am aware of. She worked full time as a marketing representative and was an active individual. She did smoke cigarettes but was a light smoker, always consuming less than 1/2 pack per day. Her smoking habit was intermittent with long periods of not smoking at all. Her weight was approximately 115 lbs. at 5í3", very much in the normal range. She was not on oral contraceptives.

Approximately nine months following the breast augmentation surgery, my daughter began to complain of headaches. The headaches

persisted so she did consult with her physician after about three weeks of suffering the headaches. Her primary physician referred her to a neurologist for an evaluation. A number of tests, including a CAT scan was ordered. All test conclusions were negative. The headaches persisted and visual problems also developed. She reported having blurred vision, flashing lights, seeing diagonal lines and black moving spots in her visual field. Return visits were made to her physicians. Migraine headaches were diagnosed by her neurologist, after all diagnostic tests were performed to rule out other diseases. Medication to treat migraines was prescribed and changed several times in an attempt to control the headaches.

At approximately one year after the implant surgery, other symptoms were reported by my daughter, extreme tiredness, bone and joint pain. The headaches continued as well.

With the thought that she might be exposed to something environmentally that triggered the headaches or that they might be stressórelated, she decided to go to Florida, with her young daughter, on a vacation. We also discussed the possibility that the implants might be causing the bizarre symptoms.

The symptoms continued while my daughter was on vacation, with the headaches being "quite severe" as reported to me when she called home while on vacation. Her ten-year old daughter also said that her mother, "had headaches all the time we were gone."

Approximately fourteen months following surgery, my daughter suffered two episodes of severe right-sided pain that lasted 2ó3 days each time. Two visits were made to the emergency room, by my daughter, when the right sided pain was severe. Tests were done but no conclusive diagnoses were made. She was told it might be related to ovulation pain.

Approximately fifteen-months after the implant surgery, my daughter began having gastrointestinal problems. She complained of having severe and persistent heartburn. Stomach x-rays were performed and when something possibly suspicious showed up on the x-ray, she was referred to a gastroenterologist for a gastroscopic exam. These results were negative for abnormal findings.

The tiredness increased and other symptoms developed; hot flashes, breathing difficulties, chest pain, fingers, ankle, and feet swelling. My daughter asked if I thought she could be going through menopause because of the hot flashes.

My daughterís close friend reported to me that Jane had also complained of pain and tenderness in her right breast and nipple for several months.

She continued to work at her job but would go to bed almost immediately upon returning home from work nightly and spent a great deal of her weekends in bed, resting. This was a total turn around for someone who had been so active and played on softball teams each summer.

Approximately seventeen months after the implant surgery, my daughter arose on Tuesday morning to go to work. Upon walking to the bathroom that morning, she collapsed in the floor. She had complained of a headache the previous night. When she collapsed her friend that lives wit her called me and asked that I come check her immediately. My daughter lived next door and by the time I arrived she was conscious but had slurred speech and a decreased level of consciousness. I am a registered nurse so I recognized immediately the seriousness of this episode. An ambulance was called and she was taken to the local hospital and then transferred to a larger medical facility immediately. A frontal lobe stroke was confirmed following a CAT scan of the brain.

Numerous tests were performed while she was hospitalized with the stroke, in an effort to determine what caused the stroke. The tests ware all negative so migraine headaches were cited as being the probable cause of the stroke,

Jana was able to return to work about two weeks after the stroke. Deficits were minimal and her physician told her net to allow the stroke to handicap her now.

The doctor prescribed a number of medications to try and help control the headaches.

She continued to complain of being tired all the time but because of her especially young daughter, desperately tried to maintain good spirits. Headaches continued and she complained that "some days ware worse than others."

Approximately five weeks after Jana had suffered the first stroke, she called me one night and said, "I have a terrible migraine. Do you think Iíll have another stroke when I get up in the morning like I did before?" That is exactly what happened.

She awoke around 7:00 a.m. and reported that she tried to sit. up and was unable to do so. She said she was also weak, dizzy, and could not sit up. She asked her friend,that lived with her to call an ambulance. I was already at work that morning when this episode occurred. Again, she was transferred to a Medical Center by ambulance, admitted, and numerous tests performed. A second stroke was diagnosed following a MRI exam. This time the stroke was in the cerebellar area of the brain. Following this stroke, she had nausea, vomiting, headaches, and balance problems that persisted. A team of cardiologists was called in for consultation in an effort to determine, why the strokes were occurring in someone so young. Extensive tests were completed by the cardiologists and in conclusion they determined that the strokes were not related to a heart condition.

Other possible causes of stroke, such as vasculitis, lupus, and autoimmune diseases were considered but lab tests did not substantiate this.

She had been in the hospital this admission (for the second stroke) six days when her neurologist recommended that an angiogram be performed. This was in an effort to obtain some additional assistance in diagnosing the cause of the headache that were leading to the strokes.

An angiogram was performed the next day and she tolerated the procedure okay. However, about four hours after the procedure, she reported seeing diagonal lines. Her blood pressure was extremely low at this time and remained low that evening, she remained on bedrest that evening and her neurologist was not overly concerned about the low blood pressure. His concern was in controlling and preventing headaches that led to arterial spasms. I spoke with the neurologist around 6:00 p.m. that evening and told him that I wanted to take my daughter to a specialty clinic for an evaluation. He agreed that this was an appropriate move and said he would help make arrangements and prepare her records. I left the hospital that evening after my daughter insisted she would be okay.

The next morning, my daughter called me at work around 9:45 a.m. to discuss travel arrangements and who in the family would travel with her. She asked that I take her young daughter out of school so that she and I could go with her. She said she was relieved that she was going for a second opinion and felt that things would be better. That was the last conversation I had with my daughter.

After she had talked with me, her friend, who was staying with her, reported that she decided to walk to the bathroom. She was assisted to the bathroom by the friend. Upon walking back to bed, she collapsed in the floor, suffering a third stroke. A comatose state resulted and Jana died two days later.

I consented to allow my daughterís organs to be used for transplants. I also requested that a complete autopsy be performed.

Complicated migraine headaches were cited as being the cause of the strokes, essentially on the basis of "rule out." No other factors known to be "stroke risks" could be found as reported by the pathologist. I did request that tissue be tested for silicone migration. The pathologist said he was unaware of the methods used and did not have the equipment to do so.

The Organ Donor Association reported to me that one kidney was unsuitable for transplantation and that it was sent to a research canter. I was able to locate the center and contacted them, and was told they did have a portion of the frozen kidney tissue there. I was told it would be released to me when and how I requested. It took several weeks for me to contact and make arrangements with a pathologist who had a knowledgeable background in silicone tissue testing. The pathologist then forwarded me a letter of acceptance and specific instructions for the research center, on the best method to ship the frozen tissue. I forwarded the letter to the research center and followed up with a phone call a few days later to verify that everything was in order. I was told during this followóup call to the research center, that the frozen kidney tissue specimen could not be located now because "someone had probably decided to clean the freezer out and had thrown it out. I inquired how this could have happened. I had made numerous calls to verify that I wanted the tissue preserved and that it might take several weeks, or even months, before I would be requesting release of the tissue to another lab. On each of my calls, I had been assured by a staff member, that there was no way anything would happen to the tissue, and that it would remain labeled while in storage, until I gave my permission and instructions for it to be transferred to another research laboratory. The conclusion one draws from this tissue being discarded, is obvious.

In conclusion, I do know that my daughter had no documented major health problems prior to the implant surgery; that symptoms including headaches and systemic symptoms started around nine months after silicone breast implant surgery, and that the symptoms increased during this second nine month period, post-surgery, and

up to the time of her untimely death. Jane was not yet thirty years old when she died. I do believe that the implants were a contributing factor in the cause of her death. I am angry. I am angry that more information was not given to her prior to surgery on the possible healthcare risks related to rupture of silicone Implants.

What I am unable to report to you is the extent of shock, disbelief, and grief that our family went through during her nine-month illness and eventual death. There are no words to express the sorrow that her father and I, her young daughter, her two brothers, and her elderly grandparents, felt at her death, and still feel. This should not have happened. Janeís gone and our lives are changed forever.

I sincerely hope end pray that no other individual or family will have to endure this type of tragedy.

Sincerely,

Janet

FDA 000053581

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