In recent years, silicone-based injectables have been discovered to have serious or life-threatening side effects. It may not be surprising that the FDA issued a warning earlier this year about rare but potentially deadly cancer risks for patients with certain types of breast implants.
Currently, both silicone- and saline-based implants are on the market. Since the 1990s, women have complained about pain, lumps and swelling, in addition to autoimmune disease-like symptoms that don’t subside after surgery or appear later. Unfortunately, doctors may have attributed these symptoms to another condition, unaware of the risks certain types of implants pose.
What should you be aware of when it comes to potential breast implant dangers?
FDA’s Latest Warning
The FDA’s warning in February 2019 cites 660 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) from the past 10 years, with just over 450 cases confirmed. This rare cancer, strictly associated with breast implants, may further be linked with at least nine deaths in the US.
Those with textured implants appear to have a higher risk but regardless of the type and model, these risks still remain very small. A 2017 study found that one out of every 3,817 to 30,000 women with breast implants develop BIA-ALCL. The condition, a form of non-Hodgkin’s Lymphoma, is often found in the fluid buildup and scar tissue near the implant.
This warning is hardly the FDA’s first. Multiple reports around a smaller number of cases spurred the agency to issue a statement back in 2011.
Why There’s No Recall
Simply put, the data collected presents multiple inconsistencies. For a stronger understanding, the FDA continues to work with other health agencies to uncover details. Certain issues have emerged thus far:
- Types of Implants: Not every report received by the FDA mentions texture. However, current data shows a correlation between textured implants and the development of BIA-ALCL.
- Treatment: Patients often discover they have BIA-ALCL when they return for a follow-up visit concerning pain, fluid accumulation, lumps, swelling or asymmetry at the surgical site after they have fully healed from the procedure. At these appointments, doctors treat the symptoms without offering a diagnosis or they misdiagnose patients with mastitis, shingles or another illness.
- Recalls vs. Awareness: France’s National Agency for the Safety of Medicines and Health Products (ANSM) required implant manufacturer Allergan to recall its textured implants over cancer concerns. In the US, the FDA has been pushing for more awareness, sending safety communications about BIA-ALCL to doctors and other medical professionals to help better identify the condition and assist at-risk women. Information about the disease comes through the Plastic Surgery Foundation and the National Comprehensive Cancer Network (NCCN).
Warning Letters to Manufacturers
In March, the FDA issued two warning letters to breast implant manufacturers Mentor Worldwide, LLC and Sientra, Inc. They failed to comply with their Class III premarket approval guidelines concerning long-term safety and risks associated with silicone-gel based implants.
For Class III devices, the FDA requires premarket and post-market studies. For breast implants, manufacturers have conducted extensive premarket research but do minimal follow-up with patients. Added to these points, the lack of data obscures potential safety concerns for approved products. Especially as the FDA banned silicone-based implants from 1992 to 2006, manufacturers need to address and answer questions related to safety concerns not factored into their initial studies. Along with using adverse event reports, the National Breast Implant Registry (NBIR) and scientific studies, the FDA may use a manufacturer’s data to issue a warning letter or pull a product completely.
As part of the FDA’s Medical Device Safety Action Plan, letters get sent when manufacturers have a low number of patients, poor or inconsistent data and a small number of follow-up cases. Why were these two manufacturers warned?
- Mentor: Concerning its MemoryShape implants approved in 2013, a low number of patients were enrolled in the initial study. From this already-small group, Mentor was hesitant to follow up. Stemming from this, research presented multiple data inconsistencies and did not adequately record information related to race and ethnicity.
- Sientra: For the Silicone Gel Breast Implants, also approved in 2013, Sientra failed to follow up with roughly 40 percent of its initial group – below the FDA’s minimum.
Were you or a loved one diagnosed with BIA-ALCL? If you were not adequately warned about the condition or doctors misdiagnosed your symptoms, it’s time to hold the manufacturer and medical professionals accountable. Bring your claim to Trantolo & Trantolo’s product liability lawyers today.