Posted in Product Liability on December 9, 2019

Opting for breast augmentation or reconstruction using implants could come with unexpected risks and serious health concerns. As federal consumer safety organizations such as the Food and Drug Administration (FDA) learn more about the potential long-term effects of breast implants, they are warning consumers to stay away from certain types and models such as Allergan BIOCELL textured breast implants. They are also spreading awareness of more general risks that could accompany breast implants, such as breast pain and implant rupture. If you suffered injuries, illness or cancer due to your breast implants, talk to an Allergan breast implant cancer attorney about your rights. The breast implant manufacturer may owe you compensation.

Cancer Related to the Recalled Allergan Breast Implants

A popular breast implant manufacturer, Allergan, is at the center of a current Class I recall by the FDA – the most serious type of product recall. The FDA is warning patients of the serious risks of receiving certain Allergan breast implant products, including all Natrelle BIOCELL textured breast implants and tissue expanders. The reason for the recall is evidence connecting these products with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). This is a serious cancer of the immune system that could prove fatal for patients.

According to the FDA, patients who receive the recalled Allergan breast implants are about six times more likely to develop BIA-ALCL than patients with textured implants from other brands. The FDA has documented 573 reported cases of BIA-ALCL worldwide; 481 of these patients had Allergan breast implants at their times of diagnosis. Symptoms of BIA-ALCL include accumulation of fluid surrounding the implant, lumps, pain, changes in breast shape/size and skin redness. If you notice any potential symptoms as someone with Allergan breast implants, go to the hospital right away.

Other Breast Implant Complications

Unfortunately, immune system cancer is not the only risk or health complication you could suffer from breast implants. Physicians have documented dozens of issues connected to breast implants and tissue expanders over the years, including breast implant illness (BII). BII can occur as the body’s reaction to a foreign body or toxicity from breast implants. BII can cause symptoms such as fatigue, memory loss, brain fog, muscle aches, hair loss, infections, stomach problems and rashes. Many patients suffer BII symptoms for weeks before recognizing the true cause. Breast implants could also cause many other complications.

  • Breast cancer
  • Breast sensation changes
  • Breast tissue atrophy
  • Breastfeeding complications
  • Capsular contracture
  • Connective tissue disease
  • Implant rupture, leaks or deflation
  • Inflammation/irritation
  • Reproductive problems
  • Revision or removal surgeries

Before you opt for implants for breast reconstruction or augmentation, learn about the potential risks to your health and safety. Many patients do not fully understand the possible risks of receiving breast implants until it is too late. Then, these patients may suffer permanent disfigurement, multiple surgeries, expensive medical bills and long-term health effects from their implants. The lack of awareness regarding breast implant complications is why the FDA has recently pushed for stronger warnings and regulations from manufacturers.

New FDA Boxed Warning on Breast Implants

On October 23rd, 2019, the FDA issued new breast implant guidelines that recommend better labeling and warning information on saline and silicone-filled breast implants. The FDA is suggesting that breast implant manufacturers include boxed warnings, patient decision checklists, better materials and device descriptions, labels listing the chemicals and heavy metals in the implants, rupture screening recommendations, and patient device cards on each product.

The FDA hopes its new recommendations will better educate patients on the potential risks and complications related to breast implants for more informed decisions in the future. If a patient still decides to receive the implants, the FDA believes new boxed warnings will at least give the patient the information necessary to watch for potential signs of complications in the future, including breast implant illness or different types of cancers. More information could help patients receive the medical care they need to treat breast implant complications sooner.