Federal lawsuits against Allergan’s Natrelle Biocell Textured Breast Implants emerged months after its manufacturer, Allergan, recalled it. The U.S. Judicial Panel on Multidistrict Litigation consolidated all federal into an MDL class action in New Jersey (most recent court order). The MDL lawsuits allege that the implants cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer.
August 21, 2023: A woman from Delaware County, Pennsylvania, just outside Philadelphia, became one of the most recent plaintiffs to file a case in the Allergan breast implants class action lawsuit. According to the Complaint, which was filed directly in the Allergan MDL earlier this month, the plaintiff got Allergan silicone-filled breast implants in 2015 and they had to be removed 4 years later. The plaintiff has not been diagnosed with cancer yet, but her lawsuit alleges that the breast implants significantly increased her risk of developing cancer in the future, and caused emotional suffering.
August 16, 2023: There are now 1,157 pending cases in the Allergan breast implant class action lawsuit in federal court in New Jersey. As of May 15, 2023, there were 1,129 pending cases in the MDL, so there has been minimal growth in this mass tort recently.
Background of Allergan Lawsuits
Certain textured breast implants and tissue expanders have been linked to the development of a rare type of non-Hodgkin’s lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The World Health Organization classified BIA-ALCL as a type of T-cell lymphoma that can develop in the scar tissue and fluid around breast implants. As of June 2020, there were 903 cases of BIA-ALCL reported worldwide, with 84% of those cases linked to a specific brand of textured breast implants.
In response to the rising number of BIA-ALCL cases, the U.S. Food and Drug Administration (FDA) requested in July 2019 that the manufacturer of the textured breast implant recall its implants from the U.S. market. Despite the recall, hundreds of thousands of women continued to receive these textured breast implants, which were sold from 1998 to 2019, potentially putting them at risk for developing BIA-ALCL.
MDL Centralization in the District of New Jersey
The U.S. Judicial Panel on Multidistrict Litigation centralized all Federal Allergen Biocell Textured Breast Implant lawsuits in an MDL in the District of New Jersey in December 2019. The lawsuits pertained to the breast implants’ association with BIA-ALCL are consolidated in MDL No. 2921,
Their common facts comprised whether the implants cause BIA-ALCL, whether Allergan knew or should have known of the risk, whether they provided adequate warnings, and whether their product testing, manufacturing, and development standards were adequate.
One MDL lawsuit involved a fatality. The plaintiff is a widower from Florida whose wife died from BIA-ALCL. He alleged that doctors diagnosed her with BIA-ALCL after she discovered a rash on her right breast. She underwent surgical removal of her implants and capsules. The surgery was unsuccessful. She underwent cancer treatment, which damaged her nerves. Doctors stopped her treatment. The woman developed an enormous mass on her chest wall, which doctors removed. Two months later, a CT scan revealed multiple chest tumors. She did not continue radiation treatment because it caused intense pain. The woman received hospice care and died shortly after. While an extreme case, it is still a risk one takes when electing to receive Allergan’s textured breast implants.
FDA Warning Letter and Manufacturer Campaign
After the recall of the implants in 2019, the FDA issued a warning letter to the manufacturer in May 2020 for its failure to complete post-market safety studies. The manufacturer did not adequately collect data from patients for a safety study, which was a condition of the FDA’s approval of the breast implants. To try and identify and alert patients who may have received the specific textured implants and tissue expanders, the manufacturer launched a social media and internet campaign.
Allegations of False Claims by the Manufacturer
The manufacturer falsely claimed that textured implants were a better option than smooth implants because they reduce capsular contracture and provide better positioning and adherence to tissue. However, studies have shown that these claims are untrue. In fact, texturizing actually increases the capsular contracture rate, according to a 2011 study. In a 2014 clinical trial, it was determined that there were no significant differences in capsular contracture rates between textured and smooth implants. A 2018 long-term study found that textured implants were more frequently associated with problems related to implant performance failure and pain.
Manufacturer’s “Warranty Programs”
In an attempt to mitigate potential lawsuits, the manufacturer offered two “warranty programs” for patients who received its textured implants.The controversy surrounding Allergan’s textured breast implants highlights the importance of patients being fully informed about the potential risks and benefits of medical devices. Women who have received textured breast implants and are concerned about their health should consult with their physicians and consider speaking with an attorney to understand their legal options.
For those who have been diagnosed with BIA-ALCL, the impact can be devastating. The lymphoma can cause a range of symptoms and can be difficult to treat, with some patients requiring chemotherapy, radiation, or surgery. Additionally, the emotional toll of dealing with a cancer diagnosis and the potential long-term health implications can be significant.
Fortunately, the ongoing lawsuits and settlements provide hope for those who have suffered harm due to the negligence of manufacturers and medical providers. By holding these companies accountable, patients may be able to receive compensation for medical expenses, lost wages, pain and suffering, and other damages.
What Is Allergan’s Natrelle Biocell Textured Breast Implants?
Plastic surgeons use Allergan’s Natrelle Biocell Textured Breast Implants for breast augmentation, reduction, and reconstructive surgeries. Irish-based pharmaceutical company Allergan manufactures them. Their outer shells are made of silicone elastomer, containing rubber-like elastic properties. They are filled with sterile saline, a saltwater solution.
Different Categories of breast implants?
Breast implant categories comprise its filing and outer shell. Filing types are silicone or saline. Outer shell types are textured or smooth.
- Silicone: Silicone implants are pre-filled with a silicone gel before surgery. The gel imitates the feel of human fat. They look natural and are less visible through the skin than saline implants.
- Saline: Saline implants comprise a sterile saltwater filling. They may be pre-filled before surgery or filled and adjusted after. Saline implants have the same consistency as water. They feel harder than silicone implants. Its folds might be visible through thin skin.
- Smooth: Smooth implants are round. They feel soft and natural. Smooth implants move more freely than textured implants, mimicking natural breasts.
- Textured: Textured implants are thicker than smooth implants. They feel rough, like sandpaper. Once filled, they feel firmer than a smooth implant. Textured implants can be round or teardrop-shaped. Doctors may recommend textured over smooth implants if the patient suffers from conditions that cause the breast bone to convex or concave. Smooth implants are prone to sliding in and out of the desired area. A textured implant’s firmness prevents this.
What is breast implant-associated anaplastic large cell lymphoma?
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare cancer of the immune system. Doctors diagnose fewer than 10 patients with BIA-ALCL each year. BIA-ALCL is not breast cancer. It is a T-cell lymphoma that occurs in some individuals with breast implants. BIA-ALCL occurs around scar tissue surrounding the implant. Advanced cases spread to the lymph nodes near the breast. It progresses slowly. Surgically removing the implants and scar tissue usually treats BIA-ALCL. While rare, BIA-ALCL may be fatal if it spreads to other lymph nodes throughout the body.
Many of BIA-ALCL cases involve textured implants, such as Allergan’s Natrelle Biocell Textured Breast Implants. The filing is unrelated to risk. Textured implants are more likely to cause inflammation than smooth implants. Some contributing factors include the body’s reaction to implant particles, allergies, genetic factors, or bacterial growth around the implant’s surface.
BIA-ALCL symptoms include:
- Swelling in the breast or around the implant
- Accumulating fluid in the breast or around the implant
- Breast size and shape changes
FDA’s Class I Recall
Allergan announced a voluntary recall of these breast implants in July 2019. This happened shortly after FDA’s recall request. The FDA made this request after they reported 573 global BIA-ALCL cases, of which 481 involved Allergan’s breast implants. This included 33 deaths, of which 13 cases occurred where they knew the specific implant. 12 of them involved Allergan’s breast implants. The remaining 20 comprised of cases involving unknown manufacturers. They concluded that Allergan’s textured implants are six times more likely to cause BIA-ALCL than other textured implants.
After the recall, the company offered victims:
- A new Biocell replacement
- $1,000 for diagnostic tests
- $7,500 for cancer surgery.
Most women really harmed rolled their eyes and filed a lawsuit and are now in the MDL class action.