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FDA Recommends “Black-Box Warning” for Breast Implants

USA- writes that the Food and Drug Administration (FDA) is changing its stance on breast implants and recommending that the devices be labeled with a boxed warning. The FDA “black-box warning” is used to warn patients and medical providers when a drug or medical device presents serious risks.

The warning would include a range of possible complications resulting from getting breast implants, including joint pain, fatigue and a rare form of cancer. The proposed warning would also state that breast implants should not be considered safe for life-time use. Complications with implants have been shown to increase as the implants age. As a result of the shelf life of implants, patients might need to pay for additional surgeries after anywhere from five to fifteen years. 

Patients who get breast implants may also find that the size or type of implant they chose does work well after they age, go through pregnancies or menopause. This could also lead to the patient needing to undergo another surgery. In 2018, breast augmentation was the most popular form of cosmetic surgery in the United States. The procedure costs about $3,824 on average. 

The FDA’s new guidelines came out after women spoke at a panel about the complications they experienced from breast implants, including cancer, and stated that they were not given adequate information about the possible risks and complications before they decided to have the procedure performed. 

Last July, Allergan, a manufacturer of textured breast implants, recalled its products after connecting the implants to a rare form of cancer. The type of implant Allegan voluntarily recalled is not commonly used in the United States. 

Breast Implant Cancer Victims Are Out There

Can You File a Lawsuit for Your Breast Implant Lymphoma?

If you or your child developed breast cancer related to your textured breast implants, you may be entitled to compensation for any medical bills, surgical costs, prescription painkillers, lost income, scarring and disfigurement, and mental pain and anguish you may have suffered.

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The Law Offices of Jason Turchin has the unique experience that makes all the difference in the outcome of you or your loved one’s product liability lawsuit. Call 1-800-510-0750 to receive your consultation.