FDA adds boxed warning on breast implants

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FDA adds boxed warning on breast implants

Recently federal regulators placed a so-called “black box warning” on breast implant packaging.  Furthermore, the FDA told manufacturers to sell the devices only to health professionals who review the potential risks with patients before surgery.

These warnings and a new checklist advise patients of the risks and side effects of breast implants.

For example, breast implants have been linked to cancer of the immune system and to a host of other chronic medical conditions, including

  • autoimmune diseases,
  • joint pain,
  • mental confusion,
  • muscle aches,
  • and chronic fatigue.

The new requirements follow years of complaints from tens of thousands of women who received breast implants and later suffered from brain fog, fatigue, and other health issues, collectively known as “breast implant illness.”

Many “activists have long sought an informed consent process for patients, so they have a clear understanding of the risks and benefits before they opt for surgery.

Long-time readers know that I always recommend that before any elective procedure you find out all of your potential benefits, risks, and costs. It wise to be a wise consumer of health care services.


© Copyright WLL, INC. 2021. This blog provides healthcare tips and advice that you can trust about a wide variety of general health information only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment from your regular physician. If you are concerned about your health, take what you learn from this blog and meet with your personal doctor to discuss your concerns.

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