Breast Implant Cancer Risks, Health Side Effects Outlined in New FDA Warnings

Requirements include a Boxed Warning about breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and a mandatory patient decision checklist, among others

Federal health officials have added new boxed label warnings for breast implants, as well a series of restrictions and pre-operation requirements, following years of concerns over the risks of breast implant cancer and other health complications.

The U.S. Food and Drug Administration (FDA) announced the new safety requirements for breast implants on Wednesday, which are primarily designed to make sure women are adequately informed about the potential health risks.

Breast implant manufacturers are now being required to add a prominent “boxed” warning, and new restrictions have been imposed, including a mandatory patient decision checklist, and screening recommendations for silicone gel-filled breast implant rupture lists.

Checklist To Make Sure Women Understand Breast Implant Problems, Risks

The move likely to have the most effect, however, is a checklist that each patient will receive before agreeing to receive breast implants. The FDA is restricting the sale and distribution of breast implants only to health care providers who give prospective patients the Patient Decision Checklist, which must be reviewed by the patient with the health care provider. The patient and physician must initial and sign the checklist before the device can be implanted.

“The FDA is requiring these restrictions based on its finding that the available information indicates such restrictions are necessary to provide a reasonable assurance of the device’s safety and effectiveness,” the FDA press release states. “The FDA is committed to continuing to use its full authorities to ensure the post-market safety of medical products.”

The breast implant black box warning is designed to alert patients to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a rare form of lymphoma that has been found to develop in tissue surrounding certain types of implants; primarily those with a textured surface.

Other changes include updated silicone gel-filled breast implant rupture screening recommendations, a requirement that each implant contain a device description with a list of specific materials and ingredients used in the implant which could be released into the body , and a patient device card identifying which implant the patient has implanted.

The new requirements were first proposed in a final guidance on breast implants issued in September 2020. However, since then, the FDA has decided to make the requirements mandatory instead of suggested as part of a new guidance.

The FDA has called for breast implant manufacturers to update device labeling on their websites within the next 30 days.

In addition to the new requirements, the FDA has released additional status information on breast implant manufacturer post-approval studies.

Breast Implant Health Concerns

The FDA indicated last year that the final guidance was influenced by new data on both BIA-ALCL and “systemic symptoms commonly referred to as breast implant illness (BII)” which some patients linked to their implants.

BIA-ALCL is a form of non-Hodgkin’s lymphoma linked by numerous studies and FDA researchers to textured breast implants, which has now resulted in a growing number of breast implant lawsuits filed on behalf of women who were never warned about the potential risk.

According to a FDA update about the risk of breast implant malignant lymphoma issued in August 2020, at least 733 cases of ALCL have been identified worldwide among women who received breast implants, with at least 620 of the cases linked specifically to Allergan implants.

Allergan issued a breast implant recall for its textured Biocell implants in 2019 after the FDA determined the design was linked to nearly all cases of BIA-ALCL. Since then, doctors have determined removing the implants is the best means of treating BIA-ALCL in most cases, but the manufacturer continues to refuse to pay for women to have the recalled breast implants removed.

Since the recall, there has been a sharp rise in the number of lawsuits filed against Allergan over the breast implants, each raising similar allegations that the textured design was unreasonably dangerous and defective.

Given similar allegations raised in breast implant lymphoma lawsuits filed throughout the federal court system, cases brought in U.S. District Courts nationwide are all centralized before one judge in the District of New Jersey, for coordinated discovery and pretrial proceedings as part of a federal multidistrict litigation (MDL). However, if settlements or another resolution for the litigation is not reached, each individual claim may later be remanded back to separate federal courts nationwide for separate trial dates.

In addition, many doctors now recognize certain symptoms among women as potentially being linked to their silicone implants, including fatigue, cognitive problems, muscle and joint pain, hair loss, infections, gastrointestinal problems, rashes and thyroid issues. These are collectively known as Breast Implant Illness, and are not well understood at this point.

In the August 2020 update, the FDA announced it has received 2,497 reports consistent with symptoms of Breast Implant Illness from November 2018 to October 2019. Before that, from January 2008 to October 2018, there had been only 1,080 such reports.