Allergan Breast Implant Lawsuits

The U.S. Food and Drug Administration (“FDA”) recently took action to protect women from the potentially dangerous side effects of Allergan textured breast implants.

On June 24, 2019, the FDA announced that breast implant manufacturer Allergan, at the FDA’s request, was recalling the company’s BIOCELL textured breast implants from the U.S. market. The company had already implemented similar recalls in 38 other countries, but had continued to supply U.S. doctors with the products until the FDA requested the recall.

This recall is the culmination of years of investigation into breast implants and their potential connection with a rare blood cancer called anaplastic large cell lymphoma (ALCL). Research so far has indicated that textured breast implants, more than smooth implants, can create an environment more conducive to cancer growth.

Chaffin Luhana is investigating cases in which women suffered serious injuries and/or death because of Allergan textured breast implants.

What are Allergan Textured Breast Implants?

Breast implants, used for cosmetic enhancement and reconstructive surgery after mastectomy, come in two basic types:

Smooth: These have a smooth, soft surface and create a look that is equally full on the top and bottom of the breast. They can move within the breast implant pocket, which creates a more natural movement of the breasts. They can also lead to slightly visible rippling, however, and if they shift after healing, can cause the breast to appear misshapen.
Textured: These have a rougher, textured surface and can be used to create a more natural-looking breast that is fuller at the bottom but not quite so full on the top. The implant adheres better to tissue, making it less likely to move around once it’s positioned. These implants have been linked to serious health issues, however.

When breast implants first came on the market, the smooth design was the only one available. But manufacturers soon started designing and producing textured implants to reduce common complications of implant surgery, including the following:

Capsular Contracture: This occurs when scar tissue around the capsule becomes unusually hard and contracts around the implant, causing the breast to appear misshapen.
Movement: Excessive movement of the implant within the breast pocket can create unnatural shapes.

Once textured breast implants came onto the market, they were often used instead of traditional smooth implants because they held their position better, and therefore maintained the desired shape of the breast. To achieve a more naturally shaped breast, without the fullness in the upper portion, textured implants were the only option. These implants also tended to look and feel firmer and were preferred for so-called “teardrop-shaped” implant procedures. And as manufacturers hoped, studies indicated that they did seem to be superior to smooth implants when it came to decreasing the rate of capsular contracture.

Allergan produces many different types of breast implants, including both smooth and textured. Its textured line is identified with the word “BIOCELL,” and includes both saline-filled and silicone-filled varieties.

Allergan makes its textured implants using a “lost-salt” technique. Before the silicone surface dries, it is pressed into a bed of fine, granular salt and then cured to create an irregular pattern of surface pores—a rough, slightly pocked surface. Other manufacturers employ different methods to create texture in their implants.

Allergan implants affected by the recall include:

Natrelle Saline
Natrelle and McGhan 410
Natrelle and McGhan 410 Soft Touch
Natrelle 510 Dual-Gel
Natrelle INSPIRA
Natrelle and McGhan Round Gel
Natrelle Komuro
Natrelle Ritz Princess
Natrelle 150 Full Height and Short Height

The recall also includes Natrelle 133 tissue expanders with and without suture tabs, and Natrelle 133 Plus tissue expanders.

Textured Breast Implants Increase Risk of ALCL

After textured breast implants had been on the market for a while, it came to light that they could cause serious health problems—most seriously, breast implant-associated (BIA) ALCL.

BIA-ALCL is a rare type of blood cancer (lymphoma) that can develop around textured breast implants with either silicone or saline filling. It is not a type of breast cancer, but a cancer of the immune system. It usually appears first in the fluid surrounding the implant, between the capsule and the implant. With time, it can spread to the surrounding capsule and tissue.

BIA-ALCL typically develops at least one year after implant surgery, though the average onset occurs about 7-8 years later. Symptoms may include breast enlargement and swelling, asymmetry, hardening of the breast, a lump in the breast or armpit, a skin rash over the breast, and fluid collection.

Treatment of BIA-ALCL depends on how far the disease has progressed. Surgery is usually the first step and involves removing the implant and the scar tissue around it. If the disease has spread to other areas of the body, chemotherapy and radiation may be needed. Fortunately, the disease is highly curable, with a five-year survival rate of nearly 90 percent.

Scientific research has linked textured breast implants with BIA-ALCL for years. In a 2017 review of 115 studies, for example, researchers found that though BIA-ALCL was rare, the incidence was increasing, with almost all documented cases associated with a textured device.

Bacterial biofilms have been implicated with breast implant complications including ALCL, so in a 2019 study, researchers decided to look into the formation of those biofilms more closely. They compared several different implants, including the Allergan BIOCELL implants, in the laboratory, and found that textured implants harbored greater biofilm loads than those with smoother surfaces.

In another 2019 review, researchers looked at all the available literature related to BIA-ALCL and noted that cases had increased dramatically from initial reports of 1 per million to estimates of 1 per 2,832. The increase could be explained by the “increasingly specific implant subtypes examined,” the researchers wrote, adding that high-textured, high-surface-area implants carried the highest risk of BIA-ALCL.

Some studies have looked at certain products specifically. In a 2017 study, for example, researchers examined implants made by Allergan, Mentor, and Sientra, and found that there was more “debris” shed from the Allergan implants (actual white flecks) than from the other two types of implants.

FDA Investigates Connection Between Textured Breast Implants and Cancer

Starting in 2011, the FDA began to communicate with the public concerning its findings about a possible link between textured breast implants and cancer. In January 2011, the administration expressed its concerns, stating, “the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.”

At that time, the FDA had reviewed the scientific literature and identified 34 unique cases of ALCL in women with breast implants around the world. The FDA’s adverse events reporting system also contained 17 additional reports.

Even then, because of some early studies published on the issue, the FDA suspected that textured breast implants could present an increased health risk compared to the smooth implants. Since most reported cases of BIA-ALCL lacked information about the type of implant, however, there wasn’t enough data to be sure.

To investigate further, the FDA partnered with the American Society of Plastic Surgeons to establish a registry of cases of women with breast implants who were diagnosed with ALCL. Healthcare providers were warned to be aware of the condition and its symptoms, to monitor patients accordingly, and to report all confirmed cases of ALCL to the FDA.

The FDA continued to follow the data and released updates to the public along the way, but it always stopped short of initiating a recall. Meanwhile, other countries took action. In February 2019, France’s Agency for the Safety of Medicines & Health Products (ANSM) recommended a permanent ban on the sale of Allergan BIOCELL textured implants across Europe.

That was followed by a ban of Allergan and other textured breast implants in France. In April 2019, Health Canada announced a suspension of licenses for Allergan’s BIOCELL implants, while Australia decided not to ban them, but to require additional data from the manufacturers.

In May 2019, the FDA required a black-box warning on textured implants, but still did not move to recall Allergan textured implants until July 24, 2019. That decision was based on the most recent analysis of the data at that time, which showed:

573 unique cases globally of BIA-ALCL, including 33 deaths
481 of those cases were attributed to Allergan implants
Of the 33 patient deaths, 12 of the 13 for which the manufacturer of the implant was known were confirmed to have an Allergan implant
An analysis of the data demonstrated the risk of BIA-ALCL with Allergan BIOCELL textured implants was approximately six times the risk of the disease with textured implants from other manufacturers marketing in the U.S.

At the time of this writing, the FDA was also considering recommendations for changes to the labeling of breast implants, which could include a boxed warning and a patient decision checklist to help women understand the benefits and risks. The FDA vowed to continually evaluate any new information and to take action regarding other types of implants if warranted.

Types of Injuries Associated with Breast Implants

Textured breast implants may cause the following injuries:

Pain and swelling in the breast and surrounding tissues
Infection
Breast or nipple numbness
Hardened and misshapen breasts
Complications requiring removal of implants
Nerve damage
BIA-ALCL