Decisions in the dark: The FDA, breast cancer survivors, and silicone implants

Decisions in the Dark: The FDA, Breast Cancer Survivors, and Silicone Implants warns that industry-funded data indicates that reconstructive surgery patients experience substantially more complications, ruptures and a greater need for additional corrective surgeries than women who receive implants for augmentation purposes. The report also highlights FDA research showing that silicone implants interfere with mammography and may limit future breast cancer treatment options such as lumpectomy and sentinel node biopsy.

The report reveals that:

  • After selling silicone breast implants to tens of thousands of mastectomy patients in the last 5 years, under the conditions that they participate in clinical trials, implant manufacturer Implant included only 80 mastectomy patients in their longitudinal safety study submitted to the FDA, and Mentor Corporation included 0 breast cancer patients in their only long-term study;
  • Industry-funded research reveals that reconstruction patients experience two to three times as many complications and additional surgeries as augmentation patients;
  • Most ruptures (86 percent) are “silent” and can only be detected with MRIs, yet Inamed included less than 30 women in their sample of breast cancer patients undergoing MRIs to determine rupture rates, and the medical societies for plastic surgeons do not advise women to undergo MRIs.
  • Research consistently indicates that reconstruction patients are not enjoying life more than mastectomy patients without reconstruction, and there is evidence they may be more likely to commit suicide; and
  • Breast implants can limit treatment options for later breast cancer.

View report