From Medscape General Medicine > Departments > Commentaries

Are Breast Implants Safe?

Diana Zuckerman, PhD

Posted: 10/24/2001; Medscape General Medicine. 2001;3(4) © 2001 Medscape

 

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Introduction

More women are getting breast implants than ever before. In 2000, a total of 203,310 women underwent breast implant surgery for augmentation,[1] and 82,975 women underwent breast implant surgery for reconstruction after mastectomy in 1999 (the most recent statistics available).[2] The number of women and teenage girls who chose implants to augment their breast size more than doubled between 1997 and 2000.

This dramatic increase reflects a booming economy and other factors, including the widespread belief that breast implants are safe for long-term use. This belief is supported by press coverage of a meta-analysis of research on autoimmune diseases and the widely publicized report of the Institute of Medicine (IOM), both of which summarized research that was published prior to 1999 and both of which concluded that implants probably do not cause connective tissue disease.[3,4] It is therefore not surprising that a Medscape General Medicine editorial concluded that implants are safe and that silicone gel breast implants, which are available under restricted conditions, should be approved for sale to any women who want them.[5]

Still, the editorial seems to disregard the way that the US Food and Drug Administration (FDA) regulatory process works, and, even more surprising, the editorial, and several recent Medscape articles, do not adequately consider the most recent research evidence of serious health problems linked to all breast implants, and especially silicone gel implants.

 
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References

  1. ASAPS 2000 Statistics on Cosmetic Surgery. American Society for Aesthetic Plastic Surgery (ASAPS), Inc.; 2001. Available at: http://www.surgery.org. Accessed October 18, 2001.
  2. 1999 Reconstructive Procedures: American Society of Plastic Surgeons (ASPS); 1999. Available at: www.plasticsurgery.org. Accessed October 18, 2001.
  3. Janowsky EC, Kupper LL, Hulka BS. Meta-analyses of the relation between silicone breast implants and the risk of connective-tissue diseases. N Engl J Med. 2000;342:781-790.
  4. Bondurant S, Ernster V, Herdman R, eds. Safety of Silicone Breast Implants. Washington, DC: Institute of Medicine; 1999.
  5. Sims S, Lundberg GD. Maybe now is the time to lift the ban on silicone breast implants. MedGenMed. 2001;3. Available at: http://www.medscape.com/Medscape/GeneralMedicine/journal/2001/v03.n02/mgm0402.sims/mgm0402.sims-01.html. Accessed October 18, 2001.
  6. Staff Report, The FDA's Regulation of Silicone Breast Implants: Human Resources and Intergovernmental Relations Subcommittee of the Committee on Government Operations, US House of Representatives; 1992.
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  9. FDA's Analysis of the Study of Mentor Saline Breast Implants. FDA Meeting March 1-3, 2000. Washington, DC; 2000. Available at: http://www.center4policy.org. Accessed October 18, 2001.
  10. US Food and Drug Administration. Saline-Filled Breast Implant Surgery: Making an Informed Decision (Mentor Corporation). Available at: http://www.fda.gov/cdrh/breastimplants/labeling/mentor_patient_labeling_5900.html. Accessed October 18, 2001.
  11. Brown SL, Pennello G, Berg WA, Soo MS, Middleton MS. Silicone gel breast implant rupture, extracapsular silicone, and health status in a population of women. J Rheumatol. 2001;28:996-1003.
  12. Brown SL, Middleton MS, Berg WA, Soo MS, Pennello G. Prevalence of rupture of silicone gel breast implants revealed on MR imaging in a population of women in Birmingham, Alabama. AJR Am J Roentgenol. 2000;175:1057-1064.
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  37. Laurance J. Agonizing wait for 5,000 women told that their breast implants might leak and cause cancer. The Independent. June 7, 2000. Available at: http://www.independent.co.uk/story.jsp?story=5864. Accessed October 18, 2001.
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Authors and Disclosures

Diana Zuckerman, PhD, is trained in epidemiology and psychology, and is President of the National Center for Policy Research (CPR) for Women & Families in Washington, DC.

 
 
 
 
 
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