A boxed warning is the strongest type of caution against the potential hazards a product could pose to consumers. Often called a black box warning, it is something the Food and Drug Administration (FDA) recommends for medications and medical devices that have displayed safety problems for consumers. Late last year, the FDA recommended a boxed warning on breast implants. The warning came after concern that some patients do not fully understand the risks and benefits associated with these devices. The black box warning is currently an FDA recommendation only, not a requirement.
The FDA Formed a General and Plastic Surgery Devices Advisory Panel
The FDA published an announcement of its new box warning recommendation for breast implants on October 23rd, 2019. The FDA stated the announcement came after it received new information regarding risks associated with breast implants over the last few years from its panel. It listed breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII) as two of the potential risks. BIA-ALCL is a type of non-Hodgkin’s lymphoma that could spread through the body. It can be fatal if not diagnosed and treated promptly.
The FDA stated it took several steps to further investigate and understand the potential risks associated with breast implants and breast tissue expanders. This includes creating an advisory panel in March 2019 to discuss long-term patient risks and breast implant safety. One of the recommendations the FDA received from the panel was a boxed warning on breast implants to increase patient awareness of the potential risks. The panel also recommended a new checklist during the informed consent process, improved MRI screenings for possible implant ruptures and greater transparency as to what substances breast implants contain.
After reviewing all the counsel from the panel, the FDA decided to recommend that all breast implant manufacturers include boxed warnings and patient decision checklists in the materials that go along with a breast implant purchase to ensure better understanding by patients. The FDA also recommended updates to existing labels, including information about breast implant rupture screenings for patients with silicone-filled implants. Finally, the FDA recommended easy-to-find lists of materials and patient device cards with devices.
Breast Implant Risks and Associated Complications
- Breast implant-associated anaplastic large cell lymphoma. BIA-ALCL appears to have a connection with breast implants – mainly Allergan’s BIOCELL textured breast implants and tissue expanders. These implants may cause irritation that leads to the development of cancer cells in the fluids and tissues surrounding the implants.
- Breast implant complications. Many patients have to undergo additional revision and corrective surgeries after receiving their implants due to unforeseen complications. These can include skin rippling, wrinkling, malposition, deformity or an uneven appearance. Not all patients are aware of these potential complications before their operations.
After receiving years of complaints regarding potential hazards connected to breast implants, the FDA is starting to speak up on behalf of consumers. The 2019 black box warning recommendation may lead to some breast implant manufacturers improving their warning labels and providing more detailed information about known health risks. In the meantime, consumers with health problems because of breast implants may have grounds to file injury lawsuits against manufacturers for causing their damages. Speak to a Los Angeles defective medical device lawyer if you think you have a case