Myrl Jeffcoat myrlj@jps.net

MR. SCHULTZ: Good morning. My name is William Schultz. I am representing a group of women's organizations led by Command Trust. I appreciate being given five minutes. Thank you.

Thank you for the opportunity to address this Committee on the very important question of whether FDA should approve the applications for silicone gel breast implants. For the record, I have no financial ties to either of the applicants.

Congress enacted the medical device amendments in 1976 in the wake of several tragedies, including the Dalkon shield IUD, which killed 16 women and injured countless others. Congress sought to remedy the defect by a new law, the defect being that medical devices were being marketed without any demonstration of their safety or any adequate testing.

Congress was particularly concerned about the safety of implantable devices. The basic showing that it required manufacturers of these devices to make was that there was a reasonable assurance that the device was safe and effective. In the case of breast implants, efficacy is obviously not the issue. Instead, the issue is safety.

If you think about it, for a therapeutic product, such as a heart valve, the safety standard entails a weighing of risk versus benefits to health. And so FDA may approve a product with substantial risks if it finds the benefits are even greater.

But for a cosmetic product, which is what we have before us today, there are no therapeutic benefits. For these products, the law does not allow approval if the product is associated with significant risk or even if there is significant uncertainty about safety. And I think that is a very important principle to keep in mind as we go through the next three days.

It is also relevant that the manufacturer has the burden of proof. Where there are doubts or uncertainties, then the product may not be approved because the manufacturer has not carried its burden. The law does not contemplate that the patients or consumers should bear the risk of unanswered questions.

At the October 2003 Advisory Committee meeting, there was discussion of various approval conditions and post?market studies. First, the Committee should understand that any approval conditions are not enforceable by FDA. Once the agency approves a product, then physicians are allowed to deviate from restrictions on the use of the product. And FDA has no authority to enforce those restrictions.

Second, while post?market studies may be useful, they cannot substitute for the basic safety standard in the statute. The statute does not provide that the agency may approve a product now and allow the demonstration of safety at a later date.

At the last Advisor Committee meeting, there was also discussion about whether women should have the option or the choice of using breast implants as long as they were fully informed.

Although Congress has adopted the buyer beware approach for dietary supplements and in other areas, this was not the approach that it adopted for medical devices. Instead, for these products, it has declared in law that medical devices are not to be available until the manufacturer has demonstrated safety. It is this Committee's charge to do its best to apply that law.

Congress' approach has two important benefits. First, it means that patients and consumers can be confident of the safety of device products that they use. It also creates an important incentive to the manufacturers to design their products to meet the high standard that Congress established.

Significant questions have been raised about the safety of breast implants. I'm not going to address those. But it's important, of course. These products are going to be in the body for many years. Even though the manufacturers have known about the standards of the statute for more than 25 years, we don't really have long?term data. And given the extremely high breakage rate of these products, lack of long?term data raises serious problems.

In January 2004, FDA determined that the evidence was not adequate. And the question that this Committee must look at is whether the companies have produced additional data that is sufficient to justify approval.

In conclusion, approval of silicone gel breast implants without an adequate demonstration of safety would have two very unfortunate consequences. First, we would have lost the opportunity to require First, we would have lost the opportunity to require that these products be adequately tested.

And, perhaps even more important, such a decision would send a message to other product manufacturers that the door has been open for approval of medical devices that do not meet the safety requirements established by law and that patients will suffer.

Thank you very much. And good luck.