Allergan Breast Implants: FDA Recall, Health Risks & Cancer Concerns

In 2019, the U.S. Food & Drug Administration (FDA) asked Allergan to recall certain models of its textured breast implants due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Data revealed that you are roughly six times more likely to develop BIA-ALCL if you have an Allergan textured breast implant versus textured implants from other manufacturers.

Following the recall, patients who suffered BIA-ALCL after receiving the company’s implants filed Allergan breast implant lawsuits claiming that the manufacturer failed to warn them about the risk.

Allergan breast implants are surgically implanted medical devices that increase or restore breast size. They can also be used to make breasts more symmetrical.

According to Allergan, their Natrelle INSPIRA breast implant collection has the largest selection of smooth breast implants and is popular among leading U.S. surgeons.

While Allergan’s main breast implant brand is Natrelle, it has also sold implants under trade names, including BIOCELL, CUI, Inspira, Inamed and McGhan.

Allergan previously sold smooth and textured breast implants. After the BIOCELL textured breast implant recall in 2019, the company stopped making and marketing its textured implants.

What Makes Textured Breast Implants Different?

Textured implants have an outer shell that is irregular, pebbly and rough, while smooth implants have shiny and slippery external surfaces.

According to experts, the rough surface of textured implants increases the risk of BIA-ALCL. The textured surface may create more bacteria, particle buildup and inflammation, leading to BIA-ALCL development.

Additionally, textured implants attach to nearby tissue and are more likely to stay in place, while smooth implants typically move freely beneath the skin without attaching to surrounding body tissue.

Which Allergan Breast Implant Models Were Recalled?

Allergan BIOCELL textured breast implants were recalled globally in 2019 and are no longer on the market. Implant lines in the recall included Natrelle, McGhan and Inspira.

The recall also included tissue expanders. Tissue expanders are empty breast implants that doctors slowly fill with air or liquid over several weeks to stretch the skin and prepare it for a regular breast implant.

Textured implants were first introduced in the U.S. in the 1980s, and Allergan started marketing its BIOCELL textured implants in 1988. Allergan recalled all of its BIOCELL textured devices because of an increased risk of BIA-ALCL.

Allergan’s BIOCELL textured breast implants have been linked to cancer, specifically BIA-ALCL, because of their macro-textured surface. These implants had rougher surfaces compared to other textured designs.

According to the FDA and the American Board of Cosmetic Surgery, this macro-textured design was six to 14 times more likely to lead to BIA-ALCL than other manufacturers’ textured implants.

“ … once the evidence indicated that a specific manufacturer ’s [Allergan’s] product [BIOCELL Textured Breast Implant] appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. said in a 2019 statement.

An Allergan lawsuit filed by Kim and Steve Crespo claims the BIOCELL “salt loss” texturing process produces particles and fragments that can become embedded in breast tissue after implantation. This allegedly caused Mrs. Crespo to develop BIA-ALCL.

What Is Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)?

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare type of T-cell non-Hodgkin lymphoma linked to textured breast implants.

BIA-ALCL is not breast cancer. It’s an immune system cancer that forms in the fluid or scar tissue surrounding the implant.

Between 1 in 1,000 and 1 in 40,000 people with breast implants develop BIA-ALCL. If you develop this cancer, you can likely be successfully treated and survive. However, it can sometimes be fatal.

In June 2024, the FDA was aware of at least 64 deaths from BIA-ALCL globally, 38 of which were linked to Allegan implants.

What Are the Symptoms of BIA-ALCL?

The most frequent symptom of BIA-ALCL is a buildup of fluid around the breast implant that causes swelling. BIA-ALCL symptoms typically develop about seven to 10 years after you get an implant, but they might occur sooner.

Less common symptoms include fever, skin rash, enlarged lymph nodes and weight loss.

How Common Is BIA-ALCL in Allergan Implants?

BIA-ALCL is more common with Allergan implants than other manufacturers, but the overall risk is low. At the time of the FDA recall, Allergan’s implants accounted for 84% of all BIA-ALCL cases globally. That number increased to 86% in 2024.

The risk of BIA-ALCL increases the longer you have an Allergan implant. According to a 2021 study in the Annals of Surgery, the incidence is 4.4 per 1,000 patients after 10 to 12 years. After 14 to 16 years, the rate goes up to 9.4 per 1,000 patients.

Allergan breast implants are associated with other health risks, including breast implant illness (systemic symptoms), implant ruptures and capsular contracture. These risks are universal across all breast implants.

Breast Implant Illness & Systemic Symptoms

Breast implant illness (BII) is a term that some patients use to describe systemic symptoms they experience after receiving a breast implant, like memory loss, rash, fatigue and brain fog.

Jamee Cook told Drugwatch that her implants caused her to suffer from fatigue and autoimmune disorders that led to the loss of her job.

“I was a very active mother, and the sickness I felt from the implants made it difficult to care for my children,” Cook said.

The FDA reports that the link between BII and breast implants isn’t well understood, though the agency said that the issues resolved in some patients after removing their breast implants. Research is ongoing.

Implant Ruptures & Capsular Contracture Risks

Other risks linked to breast implants include implant ruptures and capsular contracture.

A rupture occurs when the outer shell of the implant tears or a hole develops. Capsular contracture is a complication that causes your breast to harden around your implant, leading to tightening and pain.

Historically, textured implants were supposed to reduce capsular contracture rates. However, some research suggests that BIOCELL implants performed worse than other implant types and did not notably reduce capsular contracture rates.

Before the 2019 Allergan breast implant recall, the FDA identified a potential link between breast implants and associated anaplastic large cell lymphoma (ALCL) in 2011.

The World Health Organization designated ALCL that developed in people with breast implants as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in 2016.

In July 2019, the FDA received 573 global reports of BIA-ALCL, with 481 cases attributed to Allergan implants. This data led to the recall.

Since then, the agency has continued to share updates on BIA-ALCL cases. In June 2024, the FDA received 1,380 reports of BIA-ALCL, with 1,182 attributed to Allergan.

Allergan Breast Implant Lawsuits

Allergan lawsuits claim the company knew as far back as the 1990s that the BIOCELL manufacturing process could shed particles that embed in human tissue. According to the Crespo’s Allergan lawsuit, the company knew of at least 18 case reports of BIA-ALCL, 10 from their implants specifically.

The lawsuit further states that BIOCELL implants were negligently manufactured and defective.

What Should Patients Do if They Have Recalled Allergan Implants?

You should speak with the doctor who performed your surgery or another board-certified plastic surgeon if you have a recalled Allergan implant and are concerned about your health.

The FDA doesn’t recommend implant removal if you aren’t having problems, but you should monitor your health and be aware of the symptoms of BIA-ALCL.

If you are symptomatic, the FDA recommends speaking to your doctor and getting tested for BIA-ALCL. Your doctor can explain your options for implant removal and BIA-ALCL treatment if you have a confirmed diagnosis.

AbbVie, the company that bought Allergan in May 2020, also recommends registering your implant on the BIOCELL information site.

If you want to file an Allergan breast implant lawsuit, consider speaking to a lawyer to discuss any steps needed to file a potential case.

Can People With Recalled Implants Get a Free Replacement?

Patients with recalled Allergan breast implants had access to free replacements under the BIOCELL Replacement Warranty, but this program ended in July 2021.

Under the warranty, patients could have received free Allergan smooth implants to replace their textured implants. This warranty didn’t include surgical fees.

Patients who kept their implants were covered under the Natrelle ConfidencePlus warranty. This warranty included reimbursement for up to $1,000 for diagnostic fees and up to $7,500 in surgical fees related to diagnosing and treating BIA-ALCL.

People who remove their implants after July 2021 must cover their own costs.

Several countries have advised Allergan to stop selling its textured implants because of BIA-ALCL concerns. Others have suspended the company’s licenses to sell BIOCELL breast implant products.

In late 2018, the Medicines and Health Products Regulatory Agency recommended all Allergan implants and expanders be withdrawn in Europe.

Health Canada took action in 2019. Following a study that found significantly higher rates of BIA-ALCL in people with BIOCELL breast implants, the agency suspended Allergan’s licenses in May of that year.

In July 2019, the Therapeutic Goods Administration proposed canceling or suspending the use of textured implants in Australia. Allergan recalled the products from the Australian market the following month.

Is the FDA Requiring Stronger Warnings for Breast Implants?

In September 2020, the FDA announced it approved new labeling for breast implants to warn the public about the risk of BIA-ALCL and other health concerns.

The label was created with input from a 2019 advisory panel that included patients who shared their experience with breast implants, BIA-ALCL and BII.

Additionally, the FDA limited the distribution of breast implants to health care providers and facilities that use a “Patient Decision Checklist.” The checklist must be explained to patients so they understand the risks and benefits of breast implant devices.

The patient and physician implanting the device must sign the checklist.

If you want to remove your Allergan implant, you can get explant surgery with either smooth implant replacements, fat grafting or a breast lift to reshape your breast tissue and remove extra skin.

Benefits and Risks of Explant Surgery

The main benefit of explant surgery is that it’s usually curative if you’ve been diagnosed with BIA-ALCL. Removing your textured implants could also reduce your risk of developing BIA-ALCL, but the FDA doesn’t recommend removal if you are symptom free.

If you suffer from BII, removing your implants may resolve your symptoms.

Surgery to remove implants has risks like anesthesia risks, pain, scarring, infection and blood clots.

Are There Safe Alternatives to Textured Breast Implants?

Safer alternatives to textured breast implants include smooth implants and fat grafting.

Smooth implants work similarly to textured implants to increase your breast size without the risk of BIA-ALCL. According to the American Society for Plastic Surgeons, there aren’t any confirmed cases of BIA-ALCL with smooth breast implants.

Fat grafting, or fat transfer breast augmentation, is a technique that uses your fat to enhance your breast shape without implants. A surgeon uses fat from areas like your thighs or abdomen to increase your breast size by about one cup.

You should consult your doctor to determine which alternative would work best for you.