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Breast Implants: FDA Issues Strongest Black Box Warning Over Illness

On September 29, the Food & Drug Administration issued its strongest black box warning for silicone and saline breast implants, according to Georgia Public Broadcasting (GPB).

Black Box Warning

The black box warning, the FDA’s strongest
warning that calls attention to serious or life-threatening risks, is required on all breast implant labels:

  • Breast implants are not lifetime devices.
  • The chance of developing complications increases over time; some complications require more surgery.
  • Breast implants have been associated with systemic symptoms.
  • Breast implants have been associated with the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system.
  • BIA-ALCL occurs more commonly in patients with textured breast implants rather than smooth implants; people have died from BIA-ALCL.

The FDA’s move comes 18 months after an advisory panel heard from dozens of patients who said their silicone or saline breast implants made them sick. Women have reported systemic illness with symptoms such as muscle aches, joint pain, chronic fatigue, confusion, and other autoimmune diseases that improved after their implants were removed. The symptoms are known collectively as “breast implant illness.” However, the FDA’s new labeling requirement does not specifically mention this term.

Plastic Surgeon Investigating

According to GPB, an Atlanta-based plastic surgeon, Dr. Marisa Lawrence, is recruiting patients to study the impact of breast implants on women’s health and the causes of systemic illness associated with them. Her research team is comprised of surgeons, a pathologist, a toxicologist, and a microbiologist. The study will include a DNA evaluation of the capsule – the scar tissue surrounding the breast implant – to determine whether an infection is present.

We Can Help

Over the years, we’ve received many complaints from women with systemic health symptoms following breast implant surgery. The FDA’s black box warning is a step towards improving breast implant safety.

At Terrell • Hogan, we represent the injured as they seek justice. If you or a loved one became sick or developed lymphoma from textured implants or were injured by a defective medical device, it is important to consult with a personal injury attorney experienced in products liability cases, who has the resources to pursue justice on your behalf. Terrell • Hogan has hundreds of cases against Allergan concerning its breast implants. Consider contacting me at (904) 632-2424 for a free consultation.


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About The Author

Picture of Christopher Shakib

Christopher Shakib

Chris began his career fighting for victims’ rights as a state prosecutor of violent criminals. From 1992 to 1996, he prosecuted bad guys and witnessed the life-long harm criminals inflicted on their victims, because they made a conscious decision to do wrong, often for financial gain.