When we are either prescribed a medical device or choose to use one, we trust that it has been thoroughly tested for safe use. Unfortunately, this does not always happen, and patients can be seriously harmed as a result.
The Allergan Natrelle® BIOCELL® textured breast implants are one such product that has been recalled due to their significant risk of harm to consumers. These products carry a six-fold risk of developing a type of lymphoma. Learn more about this recall and what you can do if you have been harmed by these products.
Why Do Medical Devices Get Recalled?
According to the U.S. Food and Drug Administration (FDA), a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is … intended to affect the structure or any function of the body.”
Therefore, the Allergan Natrelle® BIOCELL® textured breast implants are classified as medical devices and are subject to FDA review, approval, and recall. In 2019, the administration recalled this product as part of a Class I recall, the most serious type of recall. Other recalls may fall under these categories:
- Class I recall: There is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.
- Class II recall: The use of or exposure to a product may cause temporary or medically reversible adverse health consequences.
- Class III recall: The use of or exposure to a violative product is not likely to cause adverse health consequences.
The textured breast implants faced this Class I recall due to their six-fold risk of consumers with the product developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is not a form of breast cancer; it is a form of non-Hodgkin’s lymphoma that can metastasize to other parts of the body. The warning signs of this condition include:
- Changes in breast size and shape
- Swelling around the breast
Living With a Defective Textured Breast Implant? Contact Us Today
Medical device manufacturers are required to design, manufacture, and market products that are safe for consumers’ use. Their failure to do so may make them liable for any injuries that result from their negligence.
If you or someone you love has been living with an Allergan Natrelle® BIOCELL® textured breast implant, Grossman Roth Yaffa Cohen is here to help. Our all-female team of experienced attorneys handles these important cases and will work with you to ensure your voice is heard. We encourage you to contact us to learn more about your options.
Call Grossman Roth Yaffa Cohen at (866) 629-1061 to schedule a free consultation.