Silicone breast implants: implications for society and surgeons.
In the last two years, scientific studies have confirmed that there is no significant increase in risk of subsequent breast cancer, connective-tissue disease or symptoms in women with silicone gel-filled breast implants. Despite this evidence, a moratorium (in place since 1992) on the use of these prostheses in the United States has been maintained by the pressure of overwhelming litigation. At the same time, Australian authorities also announced a moratorium, restricting the availability of silicone breast implants. Huge damages awarded by United States courts forced Dow Corning, manufacturer of a large percentage of breast prostheses, to file for Chapter 11 bankruptcy in May 1995. This effectively terminated the major source of implantable silicone for medical use. The withdrawal of implantable silicone and other implantable prosthetic material will be a significant loss for surgeons and society. This paper will highlight the consequences if reasoned scientific data are not relied on by Australian courts to assess claims for damages relating to medical devices.
Renwick
S B
SB
Sydney Breast Cancer Institute, Royal Prince Alfred Hospital, Camperdown, NSW.
D001315:Australia; D018427:Breast Implants / Q000009:adverse effects / Q000600:supply & distribution; D018795:Device Approval / Q000331:legislation & jurisprudence; D005260:Female; D006801:Humans; D016365:Liability, Legal; D012828:Silicones / Q000009:adverse effects; D006113:United Kingdom; D014481:United States
D012828:Silicones