FOOD AND DRUG ADMINISTRATION
MEDICAL DEVICES ADVISORY COMMITTEE
GENERAL AND PLASTIC SURGERY DEVICES PANEL MEETING
FRIDAY MARCH 3, 2000
DR. WHALEN: Thank you.
Next we’ll hear from Dr. Britta Ostermeyer.
DR. OSTERMEYER SHOAIB: Good morning and thank you very much for the opportunity. I am a physician trained in neurology and I helped treating patients who had local and systemic problems from silicone breast implants for eight years in Houston, Texas. I have since moved on and started to train in a second specialty. I’m currently a resident in psychiatry at Columbia University in New York City.
I paid my own way to come here and I testified as a treating physician on my patients’ behalf in the past. I have no relationships to manufacturers and I do not derive any income out of breast implants.
I would like to show you a small slide presentation and then give you my thoughts and conclusions. Among the women with breast implants that I have treated there was a subpopulation of women who only received saline implants and these patients had presented to us with local and systemic problems after they had received saline implants.
This is an overview of the problems they reported to us. These women were healthy previously. They had no other medical problems and since they had a combination out of these problems that was similar in the women that we saw and there was no other cause, we strongly felt after several years of research and seeing these patients that there might be a cause or link between receiving the medical device and getting these symptoms.
I’m showing you some pictures of patients that I have seen. You are supposed to see a reddish rash in the lower extremities. This is a lady who had saline implants and developed vasculitis which is inflammation in her blood vessels. She had strokes in the brain and she developed a gangrene and as a result her little pinky had to be amputated.
This lady had saline breast implants only and also had systemic autoimmune disease which is Lupus like and those are her skin rashes.
This lady had saline implants, also systemic inflammatory responses, and those are her skin rashes.
This is a spec scan which shows how the blood flow in the brain is distributed and we found findings similar of those seem in Alzheimer’s and women with systemic illness.
We measured autoantibodies which is an objective indicator of systemic inflammatory responses and there were lots of findings.
We also did sural nerve and muscle biopsies and had a high number of abnormalities. This is a sural nerve. You are supposed to see fibers all over the picture and you see gaps because this nerve had lost fibers due to inflammatory reactions.
The implant capsule was examined from women who had saline implants showed silicone in the surroundings. The surrounding chest wall muscle was biopsied and showed abnormalities and also showed silicone and chronic inflammatory reactions in the surrounding of the implant.
My conclusions are that saline implants can evoke systemic and local inflammatory responses. There are objective abnormalities and I believe that more data needs to be collected about saline implants.
My conclusions are that patients need to be aware of the risk of local injury as well as local inflammatory responses that can be very painful and can cause chest pain. There is a risk of systemic injury and especially in those women who already have an underlying autoimmune tendency, these women are at higher likelihood of developing systemic problems.
I think it’s important that surgeons make sure to their patients that they do understand that breast implants including saline implants don’t fix a long list of psychological and psychiatric problems including body image problems, depression, anxiety, and marital problems.
Surgeons should explore the patient’s expectations about the surgery and emphasize that surgery may not solve their problems and that, as a matter of fact, adverse effects may take place.
My last thing is about a comment on the insurance situation. There was a patient earlier you said that she couldn’t receive medical insurance anymore. My experience over eight years is that either patients are excluded from coverage if the disease that they encountered is a result of breast implants.
Once the women are labeled or diagnosed with a problem related to implants, they can no longer receive medical coverage. If they lose their old coverage and they want to obtain new medical insurance, it’s a problem because once you are ill with them, you continue medical care and the insurance companies know that. Thank you so much.