On Oct. 23, 2019 the United States Food and Drug Administration (FDA) released an announcement regarding breast implants in the U.S. according to the Washington Post. The FDA implant label announcement addressed labeling concerns for manufactures and raised awareness from physicians to try to assist patients in acknowledging the risks of breast implants.
The Importance of The FDA Implant Label Announcement
The FDA implant label announcement suggested that manufactures detail potential complications that could arise from the usage of breast implants over time. The FDA called manufacturers to print these new warnings as boxed warnings, which are the FDA’s most severe warning type.
Recommendations from the FDA implant label announcement included the risk of developing rare cancers including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), warnings that breast implants would not last a full lifetime, the potential need for additional surgeries, the increase in complication risk over time, and symptoms of BIA-ALCL and breast implant illness.
Breast implant illness is the name given to a series of symptoms in women with breast implants and can include:
- Muscle aches
- Joint pain
- Brain fog
The FDA implant label announcement was released because the organization claimed that they became aware of a large women “that they are not fully informed of the risks when considering breast implants,” according to the FDA’ Principal Deputy Commissioner, Amy Abernethy and Jeff Shuren, the FDA Director of the Center for Devices and Radiological Health. According to Shuren and Abernathy, the recommendations from the FDA implant label announcement are designed to “help inform conversations between patients and health care professionals when breast implants are being considered.”
As an increased measure for consumer input, the FDA has opened up the recommendations to public comment for 60 days before the guidance is finalized.
For more information about the risks of breast implants or BIA-ALCL, visit Parker Waichman’s Breast Implant Lymphoma Lawsuit Lawyers Page.
How The FDA Implant Label Announcement Affects Your Compensation
The FDA implant label announcement has alerted physicians and manufacturers of the risks that patients should be aware of before receiving breast implants. With these new requirements, women will hopefully be properly informed about the risks associated with receiving breast implants. For many women who have already received breast implants, however, the damage has already been done to their bodies that they were unaware of when they received their implants. If you or a loved one have experienced complications or injuries following a breast implant procedure, compensation may be available to you. In order to receive your compensation, you will need a law firm that excels in their field. You will need Parker Waichman LLP.
At Parker Waichman LLP, teams of experienced trial attorneys are prepared to pursue your case to its utmost conclusion in search of the maximum compensation possible. Don’t wait. Contact Parker Waichman today and begin your journey for justice.