FDA wants strongest warning on breast implants about risks like pain, rupture, and even a rare form of cancer

The FDA has received thousands of reports from women who blame their implants for a host of health problems including rheumatoid arthritis, chronic fatigue and muscle pain.

  • The U.S. Food and Drug Administration said Wednesday that manufacturers should add a warning highlighted by a box — the most serious type — to the information given to women considering breast implants.
  • The agency is also recommending patients complete a checklist to make sure they understand all the possible side effects of the implants, such as scarring, pain, rupture, and even a rare form of cancer.
  • In the past, the FDA has stood by its position that the implants are essentially safe so long as women understand they can have complications.

U.S. health officials want women getting breast implants to receive stronger warnings and more details about the possible risks and complications.

The Food and Drug Administration said Wednesday that manufacturers should add a warning highlighted by a box — the most serious type — to the information given to women considering implants.T

The agency is also recommending patients complete a checklist to make sure they understand all the possible side effects of the implants, such as scarring, pain, rupture, and even a rare form of cancer.

"We have heard from many women that they are not fully informed of the risks when considering breast implants," the agency said in a statement detailing the recommendations.

 

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