In 2019, the FDA requested that Allergan recall their BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system.
The FDA (U.S. Food and Drug Administration) requested that the Allergan recall include all BIOCELL textured breast implants and tissue expanders currently marketed.
Worldwide Medical Device Reports (MDRs) have indicated an increasing number of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) cases and related deaths, which are closely associated with the breast implants. At least 573 cases of anaplastic large cell lymphoma related to breast implants have been reported to the FDA, along with 33 patient deaths
Allergan Natrelle 133 and 133 Plus tissue expanders have not yet been associated with BIA-ALCL, but the devices have the same Biocell texture, which is why they were recalled. Tissue expanders are only indicated to be used for 6 months maximum, but experts do not know what duration of exposure to the Biocell texture may lead to cancer.
The FDA says the risk of BIA-ALCL with Allergan BIOCELL textured implants is around 6 times the risk of BIA-ALCL with other textured implants on the market. Macro-textured implants, like the kind being recalled, represent less than 5 percent of all breast implants in the United States. The recalled textured breast implant products include
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tab
What is BIA-ALCL?
To be clear, BIA-ALCL is not breast cancer, but rather a far less common form of non-Hodgkin’s lymphoma. BIA-ALCL is commonly found in the scar tissue and fluid near breast implants, and can potentially spread to other parts of the body.
If not diagnosed and treated promptly, patients may suffer from complications and severe cancer-related conditions, including death. Patients are encouraged to speak to their implanting surgeon and a product liability attorney. Even though the overall chance of developing BIA-ALCL is low, the Allergan textured breast implant recall indicates the serious nature of potential related health problems.
Allergan has said they are taking precaution due to recent reports of an increased cancer risk. Tens of thousands of women have been implanted with such devices over the years and may be at risk. Doctors and the FDA have urged women to consider a number of health risks before deciding on breast implants.
There may be safer ways to protect yourself against breast implant lymphoma, and may discuss with your doctor. Any women who have developed lymphoma or another cancer due to defective breast implants can contact a medical device recall attorney to discuss your legal options. Settlements and awards are likely following any injury caused by a defective medical device.
The FDA and Allergan will continue to monitor BIA-ALCL cases linked to textured breast implants and tissue expanders. The FDA also announced recommendations for label changes for breast implants to include a boxed warning indicating specific risks.
According to the American Society of Plastic Surgeons, breast augmentation was the most popular cosmetic surgical procedure performed in 2018. Millions of women have breast implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or for reconstruction after a mastectomy.
Over 310,000 breast augmentations were performed in 2018 alone. But thousands of women with breast implants have reported developing cancers and other illnesses, including several symptoms some experts call “breast implant illness.”
Some of the illnesses resemble connective tissue disease like lupus, rheumatoid arthritis and other serious autoimmune conditions. Most women with breast implants have no serious complications, but as many as 20 percent of women with implants have their implants removed within 10 years, usually due to complications.
Doctors have said implants are not meant to be lifetime devices. The FDA would like implant manufacturers to list the ingredients in implants, as reports of heavy metals have been concerning in the devices. Metals may include mercury, lead, arsenic and platinum, and dangerous chemicals.
New implant screening recommendations for those who already have silicone gel implants say women should undergo imaging scans to look for ruptures beginning five years after the surgery.
Boxed warnings are the strongest form of warning required by the FDA for product labeling. The FDA suggests warnings that may include: “breast implants are not considered lifetime devices.”
Allergan Breast Implant Lymphoma Lawsuits
Experienced medical device attorneys are now filing claims against implant makers like Allergan and Mentor for manufacturing defective products that have not been properly tested long term, and cause deadly diseases like cancer. The companies producing implants that cause cancer must be held responsible for the damage they cause.
Thus far, not many implants have been recalled. As seen in the past from many medical device corporations, legal action is the only deterrent to putting defective devices to market, and the only way to protect consumers from further injury.
The Lyon Firm specializes in representing plaintiffs in product liability and personal injury lawsuits, filed against negligent medical device companies to recover rightful compensation.