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Our settlement planning team helps people who were catastrophically injured or lost loved ones, often as a result of unsafe pharmaceutical drugs and medical devices. We work with attorneys from all over the country who routinely take these big companies to task when they fail to provide adequate warnings or testing of their products to best protect the public. We often see the FDA take matters into their own hands through new measures and regulations to prevent adverse events from happening to patients.

Last week, the FDA took a big step to help protect women’s health by giving patients better access to information about breast implants. The Agency made several recommendations to manufacturers:

  • A new boxed warning in the labeling for breast implants to help communicate risks that patients may not know about. 
  • A patient decision checklist at the end of a patient informational booklet or brochure to guide discussion during a patient’s consultation with a surgeon. 
  • Revisions to the rupture screening recommendations for patients with silicone gel-filled breast implants. 
  • Updates to patient device cards, which patients receive following surgery, to include more information such as the unique device identifier of the product, the boxed warning, and also links to the online patient decision checklist, boxed warning, and labeling for the specific implant.

The idea is to help ensure that women understand the benefits and risks of breast implants and are able to have meaningful conversations with their doctors and make informed decisions.

We commend the FDA for taking action to arm patients with the knowledge needed to be their own advocates. Of course, the first line of defense should be medical device manufacturers’ diligence in protecting consumers by adequately testing their products and warning about their inherent dangers. Together, these proactive measures can help patients understand and make informed choices about their health and safety.

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