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. The MDL lawsuits allege that the implants cause breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare form of cancer.
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.
What are the 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.
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. Their common facts comprised whether the implants cause BIA-ALCL, whether the 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.