Textured Breast Implant Lawsuits: FDA Will Study How Patients Perceive Risks and Benefits
The U.S. Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that it will take a closer look at how patients perceive the risks and benefits of textured breast implants—including cancer risks related to the products. The FDA intends to publish its findings later this year and use them to inform how it regulates textured breast implants in the future.
Allergan, a maker of textured breast implants, withdrew certain products from the market in 2019 following an FDA recall order. Textured breast implants have been linked to a form of cancer known as breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
What Are the Risks Associated With Breast Implants?
Textured breast implants have a rough surface designed to prevent migration in the body. However, these products were the subject of the Allergan recall and resulting lawsuits. Textured implants and other breast implants have been found to place patients at risk for a number of health concerns. According to the FDA, these risks include:
- Complications from implantation, such as nipple sensation changes
- Implant rupture and deflation
- Scar tissue that leads to squeezing of the implant
- BIA-ALCL and breast cancer
- Diseases of connective tissue
- Reproductive concerns
Breast implants also often entail a need for future surgery. After all, implants do not last over the course of a lifetime in most cases.
As of 2021, the FDA issued a new labeling requirement for all breast implant products. These labels describe the health risks named above. Surgeons and doctors are expected to review these risks and potential benefits with patients, per the FDA’s latest regulatory requirements.
What About Silicone Implants?
There are two types of materials used to fill breast implants: silicone and saline. Silicone-filled breast implants also come with several unique concerns. The FDA’s boxed label requirements note that these implants can have the potential to rupture, and the agency recommends rupture screenings to prevent this complication.
Additionally, research has shown that a number of health issues can result from silicone breast implants. This includes fatigue and cognitive impairment, among other symptoms. The silicone in these implants can also migrate in the body, causing a chronic inflammatory condition. (Current Opinion in Rheumatology)
Lawsuits Seek to Hold Manufacturers of Textured Breast Implants Accountable
Some manufacturers of dangerous textured breast implants face liability for patients’ health complications, including BIA-ALCL and other diagnoses. Many cases against Allergan have been consolidated into a multidistrict litigation (MDL) in New Jersey.
If you believe you may have been harmed by an Allergan implant, you could have a right to seek compensation. You or your lawyer will need to show that:
- You had an Allergan implant any time between 1998 and 2019.
- You have a recalled Allergan implant.
- You have a health diagnosis directly related to your implant, such as BIA-ALCL.
- You suffered damages as a result, such as medical bills and lost income.
A personal injury attorney can help you understand your eligibility to file a lawsuit and build evidence to demonstrate this link between a breast implant and your health condition. Fill out our contact page to learn more and get connected with a law firm today.