My name is Brenna Dowd and I have been asked to speak for Cristy Warschaw Founder of Women In Health one of the largest support groups in SO CA. She nor I have any affiliation with Mentor or Inamed. Neither of us has received monies from either company for this testimony.

I Cristy Warschaw have had both Inamed and Mentor Post 1990 SBI's (Silicone Breast Implants) I am unable to attend this hearing because of my continued health problems associated with these implants.

My history is very simple. No Health Problems until Nov. 1989 age 28 when I underwent a Mastectomy with reconstruction with SBI's. I had a family history of Breast CA and Calcified Fibrocystic Disease. I became ill as

soon as the implants were placed. I had to stop working as a Medical Administrator and stop my Master's Degree Program at UCLA. I have been on disability for most of the last 16 years. I have had 7 surgeries all associated with the implants. As of today at the age of 43, I have undergone total Mastectomy with No further Reconstruction because I am not a candidate for tram flap or any other reconstruction.

It has been discovered that I am one of the few people allergic to silicone. If I even ingest milk I could have a anaphalitic reaction as Silicone is used as a defoaming agent in processing. I can not place any silica's, silicones, dimethicone's or any ca's or cone's on my body, because I will break out in a rash. IV needles are coated with silicone and I have not been able to keep one in me for more than 1 day because of the silicone reacting and inflaming the IV site.

Having been a Support Group Leader for 12 years and having had both manufactures implants I have done a lot of investigation on both companies. My number one concern is the FDA 483 inspections. Inamed is manufacturing it's SBI's in Costa Rica (1) By what means is the FDA inspecting this Manufacturing Plant? Mentor's Manufacturing facilities in TX has failed Vescosity, dipping and humidity control over and over again. Also MDR (Medical Device Reporting) has also proven to be a problem as well.

If the FDA is taking Inamed's Chemistry and Mechanical Testing from only Inamed's say then this is a complete failure on behalf of the FDA. It is also jeopardizing every woman receiving a SBI.

Neither company has ever been able to assure shell thickness during the dipping process due to inability to control humidity. So they can not predict clinical outcomes as requested by the FDA, because each lot will produce a different result.

As a Healthcare professional who has kept clinical data for FDA experimentation and clinical trials. I have great anxiety in allowing SBI's to be placed back on the market. Also having been a Support Group Leader and seeing women affected by SBI's. I know how people fall off the studies.

1. Women will not see a reason to follow up in house with a Plastic surgeon at the recommended intervals.

2. There is no way a physician can detect a silent rupture. MRI's cost thousands of dollars.

3. The study is already set up to fail.

A. Women move

B. Women with SBI's are being treated for CA therefore their is a higher mortality rate for these women. No guards are set in place to retrieve post mortem implants for study.

C. There is a strong possibility these women can lose health insurance and will not return for Follow up appointments.

D. Women will have a problem and not return to the same surgeon. They may very well go to a surgeon who is not part of the study what happens to those implants?

E. Women do not relate their fatigue, HA's ect to implants and are seen by their personal MD's for this and may not relate these to SBI's. I have had 4 different surgeons and to this day am in possession of 4 of my 5 implants. The silent "Contained Rupture" was not noticed on MRI 2 days before I had surgery. 4 years after this rupture I had 15 granulomas removed from my chest wall by yet another surgeon. There have never been any FDA PRP reports filed on me or MDR reports on my rupture or fungus infected implants. I fell thru all the loops and as a Support Group Leader knowing about breast implants, how many of these women will fall thru the loop as well.

Women with Breast CA are to busy worrying about their lives to think about SBI's. They just want "To be whole again". Their symptoms are associated with their CA not their implants. I have personally seen this over and over again. I could go on and critize each part of the Draft Guidance for Industry and FDA Staff Saline, Silicone Gel, and Alternative Breast Implants as well as the New Recommendations Jan. 2004 but that will take up more time than I have.

If the FDA has no way of monitoring the manufacturing of Inamed's SBI's and Mentor can not meet it's basic 483 inspections then how can they, this panel or the FDA grant FDA approval for SBI's.

It is my opinion that neither company has met the FDA guidelines to demonstrate a reasonable assurance of the Safety and Effectiveness of SBI's therefore the should deny approval. After 10 years of trying, yet just not making it SBI's should be removed from the market all together.