More than 300,000 women undergo breast augmentation in the U.S. each year. Some involve breast reconstruction after a mastectomy, while others may involve elective cosmetic breast enlargement, and saline-filled or silicone gel-filled implants are often used in the procedures.
Women who have breast implantation expect that the implants will be safe. For the thousands of women with implants made by Allergan, there is no such peace of mind. Instead, they fear that defective implants will rupture or expose them to a rare form of cancer.
Breast Implant-Associated Anaplastic Large Cell Lymphoma from Allergan Biocell Implants
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer, but a rare T-cell lymphoma, a cancer within the immune system. Typically developing in the tissue and fluid surrounding a breast implant, BIA-ALCL can spread throughout the body. Why the implants can cause the BIA-ALCL has not yet been determined, but physicians theorize that it originates in the body’s response to the textured surfaces of breast implants like Allergan’s Biocell products.
Common symptoms of BIA-ALCL:
• Swelling caused by fluid build-up around the implant
• Pain in the area around the implant
• A lump next to the surface of the implant
• A lump in the lymph node in the armpit
Less common indicators are:
• Enlarged lymph nodes
• Skin rash
• Weight loss
Worldwide Recall of Allergan Textured Breast Implants
On July 24, 2019, Allergan announced a voluntary global recall of its line of Biocell textured breast implants and tissue expanders because of an alarming link to BIA-ALCL. The recall was prompted by a request by the U.S. Food & Drug Administration (FDA) after the agency received more than 450 reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths.
After reviewing those reports, the FDA concluded that the risk of BIA-ALCL from Allergan’s Biocell textured implants was approximately six times greater than other manufacturers’ textured implants. The FDA then warned that continued distribution of the Biocell products in the U.S. marketplace “would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.”
Allergan’s product warranty covers all Biocell textured implants manufactured and marketed under the brands:
These include both saline- and silicone gel-filled textured implants, but not Natrelle smooth breast implants.
Although the FDA recommends that Biocell implants should not be removed from asymptomatic patients, Allergan will provide a free pair of replacement smooth-surfaced implants but will not pay for the cost of the replacement surgery.
Ruptured Allergan Breast Implants
The risk of BIA-ALCL isn’t the only danger Allergan silicone-filled breast implant patients face. The implants can also rupture and leak their contents into the surrounding scar tissue or bloodstream.
After surgery, silicone breast implants form a capsule or shell between the silicone and the natural breast. With an intracapsular rupture, the leaked silicone rests between the shell and the scar tissue. Less common are extracapsular ruptures, where the silicone penetrates the scar tissue and could travel to parts of the body.
Speak With an Experienced Breast Implant Defect Attorney
When a product is negligently designed or made, and when the manufacturer fails to warn consumers of the harm that negligence can cause, they should be held liable for any resulting injuries or damages.
Concerned about the danger of textured breast implants, women across the U.S. – those with BIA-CLPL, others without the symptom, and still others with ruptured implants – have undergone additional surgeries to remove and replace Biocell products. They have suffered physically and emotionally, incurred unforeseen significant surgical and medical expenses (that Allergan’s warranty won’t cover), and given up wages and earning due to time away from work. And that’s wrong.
The Lamothe Law Firm is pursuing litigation against Allergan over its defective Biocell implants, fighting to recover the compensation that each client deserves. If you or a loved one has experienced a defective Allergan breast implant, please contact us today for a free consultation to learn how we will fight for you, too.