FDA joins France in banning Allergan textured breast implants

Breast implants in OR

Seven months after the French government banned Allergan textured breast implants, the FDA has followed suit in the United States.

Allergan pulled all BioCell textured breast implant products from Europe last year and from Canada in May.

Nevertheless, in early May 2019, the FDA announced  that it would allow sales of Allergan textured breast implants to continue. The FDA has been monitoring the increased risk of a type of non-Hodgkin’s lymphoma, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), since in 2011.

The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.

When the FDA advisory board met in March and declined to act, there were 457 cases of BIA-ALCL and 24 deaths worldwide. Current data boost those statistics to 573 cases and 33 deaths.

A March 2019 review of BIA-ALCL. epidemiologic data and literature is shocking:

The incidence and risk of BIA-ALCL have increased dramatically from initial reports of 1 per million to current estimates of 1/2,832, and is largely dependant on the “population” (implant type and characteristics) examined and increased awareness of the disease (emphasis added).

According to FDA, “macro-textured implants, like the BIOCELL textured implants manufactured by Allergan, represent less than 5% of breast implants sold here in the U.S.”

However, the risk of BIA-ALCL is six times greater with “Allergan Biocell textured implants than with other types of textured implants sold in the United States.”

All medical centers in the United States should follow the procedure that Penn State Hershey Medical Center pioneered for informing and treating 1,340 patients at risk of BIA-ALCL. The researchers write:

Patients educated on the disease will likely be diagnosed and treated earlier, which can prevent the need for adjuvant chemotherapy and/or radiation therapy and decrease mortality.

The ban is a radical act for the FDA. According to the Washington Post in May, “the agency has only banned two devices in its history — powdered surgeons’ gloves and prosthetic hair fibers.”

Breast implant illness

In 1992, the FDA banned most breast implants but lifted that ban in 2005. In 2006, FDA approved implants made by Allergan and Mentor with the caveat that the companies conduct long-term studies on the impact on women’s health.

In March 2019, FDA also addressed “breast implant illness,” a constellation of autoimmune problems that includes joint and muscle pain, allergies and fatigue. This is not limited to Allergan implant products.

The agency said it “doesn’t have definitive evidence demonstrating breast implants cause these symptoms,” but added that evidence supports “that some women experience systemic symptoms that may resolve when their breast implants are removed” — and that women should be made aware of the risk before getting implants.

However, in September 2018, researchers at MD Anderson “found that silicone implants are associated with some rare diseases, autoimmune disorders and other conditions; although a causative relationship has not been established.” Researchers analyzed data from almost 100,000 patients with both saline and silicone implants.

“This is important safety information for women to consider when thinking about cosmetic or reconstructive surgery with breast implants. It also underscores the need for more research in this area,” according to Mark W. Clemens, M.D., associate professor.

MD Anderson reported last year that “implants are used in nearly 100,000 reconstructions for breast cancer and 300,000 augmentations annually in the United States, according to the American Society of Plastic Surgeons.”

For patients with Allergan BIOCELL breast implants

(copied from FDA announcement)

  • If you have no symptoms, we are not recommending the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to your health care provider.
  • Know the symptoms of BIA-ALCL – primarily persistent swelling or pain near the breast implant – and monitor the area around your breast implants for any changes.
  • If you experience any of these symptoms or other changes, talk to your health care provider regarding the need for further evaluation. Evaluation for BIA-ALCL typically involves a physical exam, imaging, and/or assessment of the fluid or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
  • Based on discussions with your health care provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.
  • As with any implanted device, it is good to keep a record of the device manufacturer, unique device identifier, and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain any of this information, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.
  • Understand that most cases of BIA-ALCL occur many years after breast implant placement. Talk to your surgeon about your risk of developing BIA-ALCL.

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