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FDA Now Considering Black Box Label For All Breast Implants

FDA Now Considering Black Box Label For All Breast Implants

posted on Feb 14, 2020.

Breast augmentation surgery is arguably one of the most popular types of surgeries in the United States. Women choose this type of surgery for various reasons, but the last thing they should expect is that their implants will cause them injury or illness. At Mancini & Associates, we want to discuss a draft proposal from the US Food and Drug Administration (FDA) concerning putting a “black box” warning on all breast implants in the country. Our Sherman Oaks product liability attorneys are ready to help you get through this today.

The textured breast implant nightmare

The FDA does not issue recalls lightly, so when a recall was issued for textured breast implants manufactured by Allergan, it meant that this product could cause serious harm to consumers. The Biocell Textured breast implants manufactured by Allergan have been linked to cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare type of cancer.

BIA-ALCL is not breast cancer. Rather, it is a type of cancer found in the scar tissue and fluid near the implant caused by the implant. In some cases, this type of cancer could spread to a person’s entire body. The FDA says that BIA-ALCL can be treated successfully with surgery to remove the implants, though there have been deaths associated with BIA-ALCL.

Considering a black box warning

The FDA reserves black box warnings for the most serious drugs and medical devices that could cause harm to patients. We have learned that the black box warning the FDA is considering is intended for all breast implants, not just textured implants. While this black box warning is only in draft form, preliminary indications show that it will contain three main concerns:

  1. That breast implants are not “lifetime devices,” and women may require further surgery if complications arise.
  2. That these implants have been strongly associated with BIA-ALCL.
  3. That there are a variety of symptoms that patients have reported due to breast implants, including joint pain, confusion, chronic fatigue, muscle aches, autoimmune diseases, and more.

The FDA, because of this potential black box warning, will hopefully be saving lives. This move could force manufacturers of breast implants to more thoroughly test their products and ensure that they are safe for consumers.

Let us secure the compensation you need

If you or somebody you care about has been harmed after using a defective product, please seek legal assistance immediately. At Mancini & Associates, we have the resources and knowledge to thoroughly investigate your case and take on companies and manufacturers to secure the compensation you need. This can include the following:

  • Cost of your current and future medical bills related to the product
  • Recovery of income lost if you are unable to work
  • Pain and suffering damages
  • Loss of enjoyment of life damages
  • Punitive damages against a company or manufacturer

When you need a Sherman Oaks product liability lawyer, you can reach out to us on our website by clicking here or calling us at 818-783-5757.

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