BJ bjezra@earthlink.net

CDRH Stakeholder Meeting

November 17, 2005

My name is Marlene Keeling. I am president and a founding director of Chemically Associated Neurological Disorders or CANDO. I want to thank the FDA for the opportunity to speak before this stakeholders meeting. I am here representing consumers of medical devices. In particular I will address the approvable letter with conditions recently sent by the FDA to the manufacturers of breast implants. My concern is not with the time it took the FDA to respond to the manufactures PMA application but the science behind the decision to approve this class III device.

My concern is with the proprietary or "secret" conditions as set forth by the FDA for ultimate approval. The Washington Post quotes a cover letter recently sent by Mentor to plastic surgeons stating "In anticipation of a final gel breast approval, the FDA is requiring that study doctors send a letter to their study patients to remind them of the importance of their commitment to continue their 1-, 3-, and 5-year follow-up visits." Does this mean that the FDA is only going to require the manufacturers to follow breast implanted patients for five years? In networking with thousands of breast implanted patients, we know that often it takes seven years or more after implantation for symptoms of systemic disease to appear.

The most common local complication of implants is encapsulation. It is well recognized that this is an inflammatory response and the bodies attempt to wall off this foreign material. Recently there has been much written about inflammation and its role in systemic disease. Common sense tells me that after a number of years and when these implants start to degrade, it overwhelms the immune system and detoxification ability of the human body.

I would like to briefly review the record of the FDA and breast implant manufacturers:

• Seventeen years ago the FDA classified all breast implants into the class III category because of reports of adverse events in the medical literature.
• Fourteen years ago PMA’s submitted by manufacturers did not contain sufficient data to warrant a review by FDA
• Thirteen years ago FDA decides to allow silicone gel-filled implants on the market only under controlled clinical studies.
• Nine years ago FDA sent a letter to manufacturers detailing information needed for core studies (stage 3 studies)
• This year FDA sent manufacturers an approval letter with conditions after reviewing only one, two, and three years of data.

My understanding is that the current third generation implants being considered for approval have been manufactured since 1988. The question then becomes why do the manufacturers not have thirteen years of data or even nine years of data? I believe I know why after networking with thousands of breast implanted patients. The incidence of complications becomes too high of this non life-saving device and the women are not being followed in many cases as required by the FDA especially after they develop local complications or systemic disease.

In 1997 when I filed my first citizen petition regarding breast implants, the manufacturers were being allowed to quote a 1% rupture or failure rate and many women were being told that their implants would last a lifetime. This was the information that women were using to make a decision as to how much risk they were willing to take. After independent MRI research by the FDA it was determined that the rupture rate was 77% with silicone seen outside of the scar capsule 21% of the time. Manufacturers then changed the wording in the product insert to simply say "implants may not last a lifetime".

As stated by the Washington Post, some of the major reservations voiced by the FDA scientists and 2005 advisory panel experts involved the relatively limited amount of long-term information about the implants’ effects on women’s bodies. Paul Wooley, director of research for orthopedic surgery at Wayne State University recently stated "It’s been suspected for at least a decade that heavy metals used in manufacturing of implants might cause problems for women who receive these implants."

Independent research by the FDA published after the IOM review in 1999 found an increased incidence of fibromyalgia in breast implanted women. Independent research by the NIH also published after the IOM review, found an increased incidence of some cancers in breast implanted women including brain and respiratory cancers as well as others. I find it curious that when the manufacturers pay for studies they do not find an increased incidence of systemic disease for the most part.

Former Mentor employees reported to the New York Times that data was falsified regarding breast implants. One employee who was a former product evaluation manager from 1996 to 1998 said Mentor never met basic quality standards for implant manufacturing while he was there. One employee who supervised Mentor’s complaint department said she received about 6,000 complaints of ruptured implants in each of her three years at the company. However, in a recent filing with the FDA Mentor stated that it received a total of 8,060 rupture complaints from 1985 to 2003 or approximately 400 a year. How can the FDA rely on any data submitted by Mentor under these circumstances?

Inamed stated at the 2005 FDA advisory panel hearings that their gel implants did not leak platinum. Mentor stated that their implants did leak platinum but that it was in a zero valence. CANDO submitted data to the FDA after the advisory meeting on a woman with 1997 Mentor third-generation gel implants and her four year old son born after implantation. Both were found to have significant amounts of ionized platinum in their urine with a valence up to +4.

Ionized platinum is on the suspected list as being a neurotoxicant, immunotoxicant, respitory toxicant, and a sense organ toxicant. Dow notified the EPA in 1996 of substantial risk to their platinum catalyst used in the manufacturing of breast implants.

Any detectable level of ionized platinum is a health hazard, the more the worse it is. Several families with children born after implantation testified at and sent documentation to the FDA of significant platinum urine levels up to 382 ug/L (parts per billion per liter of urine). In an ongoing research project CANDO has now tested the urine of twenty children born to breast implanted mothers. Why is this research being ignored by the FDA?

History will reflect that it was under your administration, these devices that rupture at an alarming rate and spill chemicals and heavy metals into a woman’s body were approved due to the combined lobby effort of the chemical companies, the manufacturers, and the plastic surgeons. These are the beneficiaries who have the money to do clinical trials. It would be negligent should the FDA allow these manufacturers to follow these women for only five years. It would be negligent for the FDA not to require the manufacturers to follow-up on any children born to breast implanted women enrolled in a clinical study or not to require platinum urine testing.

Because the chemicals and heavy metals used in the manufacturering of medical devices are considered proprietary information or "secret", consumers must rely on the FDA to protect them and advise them of potential risks. If approval is given, will consumers be advised that their implants may leak heavy metals and these heavy metals if ionized may cross the placental barrier and brain barrier? I would consider it grossly negligent of the FDA not to require the manufacturers to inform consumers of this important information when making an informed decision on how much risk they were willing to take when implanted with these devices for many years and during their child-bearing years.

Thank you,

Marlene Keeling

Chemically Associated Neurological Disorders

P.O. Box 682633

Houston, Tx. 77268-2633

281/444-0662

281/444-5468 FAX

keeling.m@worldnet.att.net