Silicone breast implant litigation (Part 1)

Med Law. 1994;13(7-8):681-716.


Silicone breast implant litigation has escalated in the past couple of years with the Food and Drug Administration (FDA) investigation of silicone gel implants which resulted in finally removing the silicone gel implants from the market. Plaintiffs have linked various medical problems to the presence of silicone in the body. The FDA has stated that there is no medical evidence that silicone causes autoimmune disease. Silicone has never been shown to cause breast cancer. Breast implants can result in complications such as capsule contracture, gel bleed, implant rupture, calcifications around the implants, and possibly interference with mammography in the diagnosis of breast cancer. Plaintiffs have claimed that the implant manufacturers knew of the defects in the silicone shell implant covering, and covered up the facts. The product liability action has become a class action, and a proposed settlement has been made in terms of which implant recipients with any problems will be reimbursed. Furthermore, there will be coverage for future implant problems over the next 30 years. There will still be some litigation by those patients who have opted out of the settlement agreement.

Publication types

  • Review

MeSH terms

  • Breast Implants* / adverse effects
  • Breast Implants* / standards
  • Device Approval / legislation & jurisprudence
  • Female
  • Humans
  • Liability, Legal*
  • Neoplasms / etiology
  • Prosthesis Failure
  • Silicones / adverse effects*


  • Silicones