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June 16, 2019  
UTERINE NEWS: Feature Story

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  • Breast Implant Safety: Weighing the Risks and Gain

    Breast Implant Safety: Weighing the Risks and Gains

    January 18, 2007

    By: Diana Barnes-Brown for Uterus1

    In November of 2006, the FDA made a controversial decision to approve silicone breast implants for general cosmetic surgery. This decision came only 14 years after having reclassified them as experimental devices and restricting them to clinical trials in 1992. The reclassification came amid a storm of criticism regarding silicone implants, which resulted from multiple reports – some medically confirmed and others with strong anecdotal support – of the implants’ tendency to rupture and cause silicone poisoning and permanent health problems for women who had received them.
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    Some Reported Risks of Breast Implants:

  • Infection including toxic shock syndrome
  • Difficulty healing
  • Pain or discomfort in breasts and surrounding tissue
  • Calcification or hardening of breasts
  • Changes in breast appearance, including lopsidedness, rippling or wrinkling, or unevenness
  • Implant rupture
  • Capsular contracture (misshapenness and hardening caused by scar tissue growth)

    Additional long-term risks:
  • Cancer
  • Depression/suicide
  • Respiratory disorders

    Risks with strong anecdotal evidence:
  • Chronic immune difficulties
  • Muscle and joint pain
  • Cancer
  • Chronic fatigue
  • Nerve disturbances: tingling and numbness
  • Slow healing time
  • Mood disturbances such as depression and anxiety
  • Cognitive difficulties

  • Now that the FDA has found reason to allow silicone versions of the implants again, what should women know about the risks?

    There were over 100,000 adverse reactions to silicone breast implants reported to the Food and Drug Administration between 1985 and 1996. And in several reports released by the FDA between 2000 and the present, manufacturers’ own research showed that for many women who had received implants, complications were severe and many. A Mayo Clinic study found that about one in four women who have implant surgery need additional surgery within five years, while silicone implant maker Inamed found in 2003 that this number was as high as 46 percent.

    Some other studies looked at the long term effects of silicone breast implants. One led by Louise Brinton, Ph.D., of the National Cancer Institute (NCI), found that brain tumors, lung cancer, other respiratory diseases, and suicide are more likely in breast implant patients compared to other plastic surgery patients. Another of Brinton’s studies found a 21 percent increase in cancer among women who had implants, in comparison with the general population.

    Finally, there is a great deal of anecdotal evidence supporting a connection between silicone implants and immune disorders, mood disturbances such as depression and anxiety, joint and muscle pain, and certain cancers.

    Some risks are well-documented, while others are supported by a wealth of anecdotal evidence and have yet to be confirmed. Still, there are women who swear that the complications are worth the gains. Some women claim the confidence they gained from larger breasts improved the quality of their life in spite of complications, while some breast cancer patients find that having surgical options to regain their pre-cancer bodies can be helpful in the emotional recovery process. The American Cancer Society says that many women with breast cancer will undergo mastectomies and have to decide whether they wish to pursue options for breast reconstruction.

    The proportion of reconstructive surgeries to cosmetic augmentations in North America is roughly one to five. Often, saline and silicone implants are equally viable options for both groups.

    When it comes to decisions and motivations for surgical modifications of any kind, there are many complexities and questions to be explored. Women considering breast implants for any reason should, above all, be aware that any major surgery, including breast implant surgery, comes with documented risks, and those associated with breast implants are unique to their placement in the body and the materials they contain. Also, surgeons and other medical specialists now caution patients that implants of any kind – saline or silicone – are not life-long fixtures, and will likely require surgical interventions or even replacement after a few years.

    With knowledge of the risks, benefits, and alternatives, women can be fully informed before making the decision to opt for or forego implants.

    Last updated: 18-Jan-07


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