Cancer patients have been filing lawsuits against Allergan for its BIOCELL® breast implants. The textured products have been recalled after studies showed an increased risk of cancer – specifically BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma).

Hundreds of women have been affected by the recall of the implants. Some have even developed cancer that is related to their breast implants. Lawsuits related to the recalled breast implants have been filed.

Legal action against a drug and/or medical device manufacturer can be daunting. We all hear about how “Big Pharma” corporations have loads of money at their disposal with which to fight lawsuits. Such a case is usually filled with challenges and complexities. Regardless, if you or a family member developed cancer due to a dangerous medical device like the Allergan breast implant, you may be entitled to monetary compensation for your damages. Additionally, profitable and powerful drug and medical device manufacturers should be held responsible for selling dangerous products to the public. Lawsuits against these companies for the harm they cause could protect future consumers. Expert legal representation is crucial when initiating legal action against a dangerous drug/medical device manufacturer.

The Law Offices of Edward A. Smith has nearly 40 years of experience managing personal injury cases. Call us for compassionate, free, and friendly advice and a no-obligation review of your potential BIA-ALCL case against Allergan.

In This Article:

• History of the Allergan Implant
• FDA Action Related to Allergan Implants
• Lawsuits Related to Allergan Implants
• Allergan Implant Lawsuits: What Are the Potential Grounds?
• Breast Implant Lawsuits: Damages
• What is Breast Implant Cancer?
• Expert Legal Help is Crucial in a Medical Device Matter

Allergan Inc. began selling breast implants in 2006 and is one of the largest manufacturers of breast implants in the world. Their products are sold in more than 60 countries, with most of the sales volume being in the United States, Latin America, and Canada.   The company’s 2018 sales of breast implants in the U.S. were $263 million, over $20 million more than the previous year.

Natrelle is Allergan’s leading breast implant brand. The company also sells implants through its subsidiaries McGhan and Inamed.

Health regulators have linked Allergan’s textured implants to BIA-ALCL, a rare form of non-Hodgkin’s lymphoma. The U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO) have identified BIA-ALCL as a form of cancer that can develop after a patient has breast implant surgery.

When Allergan began selling implants in 2006, the company initiated several long-term tests to assess the performance and safety of the products. However, it is alleged that safety concerns found during those tests were not reported through the proper channels to the FDA.

As far back as 2011, the FDA reported a potential link between breast implants and lymphatic cancer, but according to the agency at the time, there were too few cases to accurately assess the risk. Since then, hundreds of women have been diagnosed with BIA-ALCL, and some have died.

In July 2019, the FDA requested a voluntary recall by Allergan of its textured breast implants after testing linked the products to hundreds of cases of cancer as well as a dozen deaths. Allergan then issued a worldwide recall of its BIOCELL® implants (textured) on July 24, 2019. The recall also included tissue expanders. Smooth Allergan breast implants were not part of the recall as they have not been linked to cancer by the FDA.

Since the July 2019 recall of Allergan’s Biocell textured breast implants, hundreds of women who had breast implant surgery have discovered that their subsequent cancer was caused by defective Allergan implants.

The precise number of cases of BIA-ALCL is not clear due to limitations in global reporting, but as of the July 2019 recall, the FDA had received 573 total reports of breast implant cancer. The  statistics that were noted at that time include:

• 573 BIA-ALCL cases have been reported throughout the world.
• Of those 573 cases, 481 (84%) patients had Allergan Breast Implants.
• BIA-ALCL Deaths: 33
• The particular brand of breast implant used was known for only 13 out of the 33 BIA-ALCL deaths – all but one of those 13 were Allergan breast implants.

The FDA reports that the products listed below were taken off the market:

• Natrelle Saline breast implants (168, 163, 363 & 468)
• Natrelle 410 Anatomically Shaped Silicone breast implants
• Natrelle Inspira Silicone breast implants (various “T” types)
• Natrelle Silicone breast implants (110, 115 & 120)
• McGhan Tissue Expander, Croissant-shaped (134)
• McGhan Bidimensional Silicone breast implants (153)
• Natrelle 133 Plus Tissue Expander (also type with suture tabs)

Watch the YouTube video: Good Morning America reports on the Allergan implant recall.

Recently filed BIA-ALCL lawsuits allege Allergan knew of the risks associated with its textured implants years before they recalled the products in July 2019. Plaintiffs seek to compel Allergan to cover the costs of surgery, diagnostic tests, and medical monitoring in patients with Biocell implants. Removal of the implants involves invasive surgery and painful recovery. The plaintiffs also must deal with the psychological effects of having a dangerous product within their bodies. For patients who have chosen not to remove and replace their Biocell implants, Allergan has thus far refused to pay for invasive diagnostic tests and medical monitoring.

A New Jersey Federal Court consolidated more than 65 cases pending against Allergan. The Multidistrict Litigation (MDL) is entitled MDL 2921, IN RE: Allergan Biocell Textured Breast Implant Products Liability Litigation. The Judge overseeing the New Jersey MDL is the Honorable Brian R. Martinotti.

A drug/medical device maker may be found legally responsible (liable) for a patient’s condition or injuries if it is proven that:

• There was a foreseeable risk inherent in the device’s design; and
• The device was manufactured and used as intended according to the design.

The design of the implant’s textured shell allows human tissue to grow into the implant’s surface, keeping the implant in place. This design is alleged to cause inflammation and scar tissue around the implant. Chronic inflammation is believed to be a factor in causing BIA-ALCL.

Manufacturer’s Defect

The medical device manufacturer could also be found responsible if:

• The device had a defect when it left the manufacturer’s possession, substantially contributing to the patient’s condition, disease, or injuries.

Improper construction of the devices by Allergan could have resulted in the product causing BIA-ALCL. This liability scenario could exist rather than in addition to design flaws.

Failure to Warn / Label Defect

Medical device manufacturers must warn doctors of non-obvious risks associated with using their devices.

Negligence by the Manufacturer

A finding of negligence requires that plaintiffs prove the following:

• Allergan (the defendant) owed the plaintiff a duty of care, and
• Allergan breached that duty of care.
• Allergan’s breach caused the plaintiff’s injury.
• The injury to the plaintiff resulted in economic damages.

It may be argued that Allergan breached its duty of care to patients by selling a device that, by its design or defect, caused chronic inflammation and carried the risk of causing rare lymphatic cancer.

Breast implant-related injuries to patients have resulted in monetary damages that include but are not limited to:

• Medical expenses – past and future
• Loss of income – past and future
• Pain and suffering
• Loss of consortium damages may be available for the plaintiff’s spouse if applicable.

Allergan’s textured implants have been linked to the development of BIA-ALCL in some women. This condition is not breast cancer but rather a form of non-Hodgkin’s lymphoma specifically related to breast implants. Lymphomas are cancers of the lymphatic system. In most cases of BIA-ALCL, the cancer cells develop in fluid and scar tissue near the implant and remain localized. In localized cases, the prognosis is good. However, this form of cancer is still severe and requires prompt treatment through surgery and/or chemotherapy and radiation. There have been cases where this type of disease spread and resulted in the patient’s death.

Some of the symptoms associated with BIA-ALCL are:

• Persistent swelling near the implant
• Pain near the implant
• Breast asymmetry or changes in appearance
• Fatigue
• Redness or rash
• Hardening or enlargement of the breast
• Lumps in the breast or armpit
• Weight loss
• Development of seromas or fluid pockets.

If you have had breast implant surgery and received the recalled implants, you may still have a legal claim even if you have not received a cancer diagnosis. If you believe the recalled Allergan implants were used in your surgery, contact the Allergan lawyers at the Law Offices of Edward A. Smith for a no-obligation case review. Even if you are not sure which brand was used, we may be able to help determine if you can take legal action.

Lawsuits against medical device manufacturers that sell dangerous products are complex and complicated. Pharmaceutical companies have deep pockets and will use their vast resources to defend against lawsuits that may affect their astronomical profits. Every state has its own time limits for filing a lawsuit. You must settle your claim or file a lawsuit within your state’s time limit to protect your right to recover damages. If you or a loved one underwent breast implant surgery and received the now-recalled Allergan breast implants, you must hire a lawyer with vast experience in litigation against medical device manufacturers.

I’m Ed Smith, a drug products liability lawyer in Sacramento, California. If you or someone you love has suffered or is suffering from Allergan breast implants or any other dangerous or defective medical device, do not hesitate to call (916) 921-6400 for compassionate, free, and friendly advice. If you are calling from outside the Sacramento region, our toll-free number is (800) 404-5400. We also offer an online contact form.

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Editor’s Note: Updated for accuracy and relevancy [cha 3.20.23]

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