[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H. Res. 527 Introduced in House (IH)]







104th CONGRESS
  2d Session
H. RES. 527

  Relating to breast implants, the Food and Drug Administration, and 
                             public health.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 19, 1996

Mr. McIntosh submitted the following resolution; which was referred to 
                       the Committee on Commerce

_______________________________________________________________________

                               RESOLUTION


 
  Relating to breast implants, the Food and Drug Administration, and 
                             public health.

Whereas breast implant safety is a public health issue of fundamental 
        importance, particularly for those women who are diagnosed with breast 
        cancer and who face urgent decisions about reconstruction and women who 
        already have implants;
Whereas conflicting information has been provided to the public about the safety 
        of silicone gel breast implants;
Whereas the Food and Drug Administration imposed restrictions on the 
        availability and use of breast implants, based primarily on concerns of 
        a possible relationship between silicone gel breast implants and 
        connective tissue disease;
Whereas breast cancer patients seeking reconstruction may only gain access to 
        silicone gel breast implants through participation in a clinical trial 
        under an approved protocol;
Whereas only a small fraction of the postmastectomy patients in the United 
        States who seek reconstruction have access to silicone gel breast 
        implants through clinical trials;
Whereas research has been undertaken by many prestigious medical centers and 
        universities on the issue of silicone gel breast implants and connective 
        tissue disease;
Whereas controlled scientific studies conducted by these prestigious 
        universities to date show no clinically relevant risk of connective 
        tissue disease for women with silicone breast implants nor any 
        connection between the devices and systemic connective tissue diseases 
        or classic auto-immune symptoms;
Whereas the Food and Drug Administration has not issued a definitive statement 
        on the relationship between silicone gel breast implants and connective 
        tissue disease;
Whereas the Food and Drug Administration has not provided substantial 
        information on breast care for women with implants;
Whereas the National Cancer Institute has not provided substantial information 
        on breast care for women with implants, waiting for the Food and Drug 
        Administration's lead in this matter; and
Whereas the controversy over silicone breast implants has a broader impact on 
        the public health by adversely affecting the supply of raw materials 
        used in other products, such as pacemakers, heart valves, hip and knee 
        joints, and artificial blood vessels: Now, therefore, be it
    Resolved, That it is the sense of the House of Representatives that 
the Food and Drug Administration should take immediate steps to--
            (1) ensure that women with breast cancer and other women 
        seeking breast reconstruction have enhanced access to silicone 
        gel breast implants; and
            (2) eliminate requirements that these women participate in 
        clinical studies in order to obtain the silicone implants.
In addition, the Food and Drug Administration should take immediate 
steps to resolve the fears and concerns of women with breast cancer and 
women who have breast implants by issuing a definitive statement on the 
relationship or lack thereof between silicone gel breast implants and 
connective tissue disease, classic auto-immune symptoms, and other 
serious diseases.
                                 <all>