Myrl Jeffcoat myrlj@jps.net

MS. PAM DOWD: Hello. My name is Pam Dowd, and I have been asked to speak on behalf of Cristy Warschaw, founder of Women in Health, one of the largest support groups in southern California for silicone breast implant women. Neither she nor I have any affiliation with Inamed or Mentor. Neither of us have received monies from either company for this testimony.

"I, Cristy Warschaw, have had both Inamed and Mentor post?1990 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 November 1989, when at age 28 I underwent a mastectomy with reconstruction with silicone breast implants.

"I had a family history of breast cancer 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 seven 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 reconstructive surgery.

"It has been discovered that I am one of a few people allergic to silicone. If I even ingest milk, I can have an anaphylactic reaction as silicone is used as a defoaming agent in processing. I cannot place any silicous, silicones, dimethicones, or any cones 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 one day because of the silicone reacting and inflaming the IV site.

"Having been a support group leader for 12 years and having had both manufacturers' implants, I have done a lot of investigation on both companies. My number one concern is the FDA 483 inspections. Inamed is manufacturing its SBIs in Costa Rica. By what means is the FDA inspecting this manufacturing plant?

"Mentor's manufacturing facilities in Texas have failed viscosity, dipping, and humidity control over and over again. Also, 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 an SBI.

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

"As a health care professional who has kept clinical data for FDA experimentation and clinical trials, I have great anxiety in allowing silicone breast implants to be placed back on the market.

"Also, having been a support group leader and seeing women affected by SBIs, I know how people fall out of the studies. Women will not see a reason to follow up in?house with a plastic surgeon at the recommended intervals.

"There is no way a physician can detect a silent rupture. MRIs cost thousands of dollars. The study is already set up to fail. Women move. Women with SBIs are being treated for cancer. Therefore, there is a higher mortality rate for these women.

"No guards are set in place to retrieve post?mortem implants for study. There is a strong possibility these women can lose health insurance and will not return for follow?up appointments.

"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?

"Women do not relate their fatigue to implants and are seen by their personal M.D.s for this and may not relate these to silicone breast implants.

"I have had four different surgeons and to this day and am in possession of four of my five implants. The silent contained rupture was not noticed on MRI two days before I had surgery. Four years after this rupture, I had 15 granulomas relieved from my chest wall by yet another surgeon.

"There has never been an FDA PRP report filed on me or MDR report on my rupture or fungus?infected implants. I fell through all the loops. And as a support group leader knowing about breast implants, how many of these women will fall through the loops as well? Women with breast cancer are too busy worrying about their lives to think about SBIs. They just want to be whole again.

"I could go on and criticize each part of the draft guidance for industry and FDA staff saline, silicone gel, and alternative breast implants, but that would take up more time than I have. It is my opinion that neither company has met the FDA guidelines to demonstrate a reasonable assurance of the safety and effectiveness of SBIs. Therefore, they should deny approval. "After ten years of trying" ??

CHAIRMAN CHOTI: If you could sum up, please?

MS. PAM DOWD: Yes. I've just got this one sentence.

"After ten years of trying, yet just not making it, SBIs should be removed from the market altogether."