Defective Allergan Breast Implants
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 are:
- 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.
In January 2011, the FDA identified a link between Allergan’s Natrelle Biocell textured surface breast implants and “breast implant associated anaplastic large cell lymphoma” (“BIA- ALCL”). BIA-ALCL is a type of non-Hodgkin’s lymphoma, a cancer of the immune system.
BIA-ALCL is not breast cancer, although in most cases, BIA-ALCL is found in the scar tissue and fluid near the breast implant. In some cases, BIA-ALCL cancer will spread throughout the body to other systems.
The main symptoms of BIA-ALCL are persistent swelling or enlargement of a patient’s breast or surrounding tissue that develops a year or more after breast implant surgery, lumps in the breast or armpit, pain, rash, redness, hardening of the breast, or changes in the shape or size of the breast.
BIA-ALCL is a serious cancer and can be fatal, especially if not diagnosed early or promptly treated. BIA-ALCL can be treated by surgically removing the implant and surrounding scar tissue. Some patients may also require chemotherapy and radiation treatments.
The symptoms of BIA-ALCL may occur years after the implant placement. The diagnostic testing recommended to determine if BIA-ALCL is present is invasive.
On July 24, 2019, the FDA issued a worldwide Class I Recall of Allergan’s Natrelle BIOCELL textured surface implants. A Class I Recall is the most series type of recall and indicates that use of the recalled product may cause serious injury or death.
The FDA issued this recall because Allergan’s Natrelle BIOCELL textured surface implants were tied to a large majority of cases of BIA-ALCL cancer and BIA-ALCL cancer-related deaths.
Immediately afterward, Allergan announced a “voluntary” recall of these breast implants, and many women received a letter from Allergan advising of the recall. This letter, which mentions BIA-ALCL cancer, started the statute of limitations clock which is running against its recipients (women with the breast imoplants) and in favor of Allergan.
A statute of limitations is the legal deadline before which you must file suit. If the legal deadline passes, you lose your right of action to file suit. Louisiana has a one-year statute of limitations. Generally, the one-year time period begins when you knew or should have known about the link between BIOCELL implants and BIA-ALCL cancer. The question to ask is when you became aware of a connection between the BIOCELL implants and BIA-ALCL cancer.
Filing suit will always be timely if done before the first anniversary of the FDA’s July 24, 2010 recall, meaning file suit on or before Wednesday, July 23, 2020. If you did not get a letter from Allergan, this is the safest course of action.
Some women with BIOCELL textured surface implants were unaware of the FDA’s July 24, 2019 recall but shortly thereafter received letters from Allergan noting the recall. These letters appear to be dated August 9, 2019 but this may not be the case with every letter. So, if you received a letter the absolute last day on which to file suit the last day before the first anniversary of the date on your letter.