How Safe Are They?


  • Breast Implant Illnesses: What’s the Evidence? A large meta-analysis of many current research studies on the correlation between breast implants and autoimmune symptoms reveals the weaknesses in each study and highlights what we do and do not know about breast implant illness.
  • Complications of Saline Breast Implants How risky are breast implants? This is a controversial question, but implant manufacturers have done research showing that local complications, including pain, rupture, and the need for additional surgery, are very common within the first three years.
  • FDA Update on Silicone Gel Breast Implant Safety: Many Unanswered Questions The FDA released a new report entitled Update on the Safety of Silicone Gel-Filled Breast Implants on June 22, 2011. The FDA summarized the report as showing that breast implants cause many complications and often need to be removed, but that if “used as directed” (including regular MRIs) implants are “reasonably safe.” However, the FDA admits that we don’t have as much safety information as we need, and that the implant companies haven’t done a very good job of doing safety studies.
  • Sientra’s Silimed Brand “Gummy Bear” Silicone Gel Breast Implants Pose Safety Questions In December 2012, the U.S. Food and Drug Administration (FDA) approved Sientra’s for its “Silimed silicone gel breast implants.” These implants are also called “gummy breast implants” because they are made of a thicker gel that is said to resemble candy gummy bears.
  • Breast Implants and Autoimmune or Connective Tissue Disease: Is There Proof? There are 20 epidemiological studies included in the meta-analysis published in the New England Journal of Medicine, to determine whether breast implants cause connective-tissue diseases. A careful review of the studies included in the meta-analysis reveals that those studies have a number of flaws.
  • Breast Implants and Mammography: What We Know and What We Don’t Know Women with breast implants and those considering breast implants need to know that they will have a different mammography experience than women without implants, since standard techniques for compression and imaging are ineffective with implants. Mammograms performed on women with implants will miss more tumors than is typical of mammograms for women who do not have implants. Women also need to understand that breast implants will interfere with mammography and mammograms might cause implants to rupture and leak.
  • Symptoms and Complications from Silicone Gel Breast Implants FDA’s October 2003 Summary of Research on Inamed Implants On October 14-15, 2003, the FDA held a public meeting to discuss Inamed’s research on their silicone gel implants. The company is asking the FDA to approve their implants as safe and effective, but the company’s own research shows substantial complication rates and worrisome increases in symptoms for women using their implants. This issue brief is based on the FDA’s analysis of the research by Inamed.
  • Are “Gummy Bear” Breast Implants the Safer Implants? Research now shows that “gummy bear” implants are probably not safer than other breast implants.
  • Are Bigger Implants Safe? Mentor Receives FDA Approval to Conduct Clinical Trials for Larger Breast Implants Recently, Mentor, a company that makes breast implants, received FDA approval to initiate clinical trials to study the safety and effectiveness of their new and larger memory gel breast implants. The largest implants currently available in the U.S. are 800cc, which is about the size of a cantaloupe. The concern about larger silicone gel breast implants, such as the ones being tested by Mentor, is that an enormous amount of silicone could leak into the woman’s body if the implant ruptures.
  • Safety and Benefits of Mentor Silicone Breast Implants From the April 2005 FDA Analysis and Meeting In 2005, the FDA noted that the Mentor Corps’ data on silicone breast implants failed to show that the implants were safe and raised questions about effectiveness.
  • The History of the FDA & Breast Implants This article details the history of breast implants and FDA regulation. This history spans from when breast implants first entered the U.S. market in the 1960s to more recently in 2011.
  • Safety and Benefits of Inamed Silicone Breast Implants In January, 2004, Inamed’s application for approval of silicone breast implants was turned down by the FDA.  In rejecting the application, the FDA noted the lack of safety data and requested better information about the rupture rate over the lifetime of the implants and the health consequences of implant rupture.  Inamed’s 2005 data do not answer these essential safety questions, and in fact contains alarming data on the frequency and risks of implant rupture.
  • The European Perspective: Do Silicone Breast Implants Cause Disease? What do all of these European studies have in common? They all found problems associated with breast implants, but they were described with rose-colored lenses to make the findings sound like a clean bill of health for breast implants.