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Manufacturer provides first-of-its-kind warranty for BIA-ALCL cases

Allergan has become the first breast-implant manufacturer to provide warranty coverage for its products in cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

According to an Allergan statement, the company's Natrelle ConfidencePlus warranty now includes "additional rare event coverage for patients with gel- or saline-filled implants diagnosed with BIA-ALCL on or after Jan. 1, 2018." BIA-ALCL is a rare lymphoma that has only been noted to occur in patients who have a history of a textured device. Although all government authorities and oncology organizations classify BIA-ALCL as a lymphoma, a rare cancer of the immune system.

Mark Clemens, MD, Houston, who is chair of the Society's BIA-ALCL Subcommittee, calls the updated warranty an "important recognition of this rare disease." Although some insurance companies do cover procedures specific to BIA-ALCL, he says the move by the manufacturer is a major step in ensuring coverage for patient safety.

The manufacturer's updated warranty includes free financial assistance of up to $7,500 in out-of-pocket surgical costs for the removal of implants and associated scar tissue from a complete capsulectomy. Allergan will also provide replacement implants at no charge if the patient opts for reconstruction.

"Allergan wants patients to have peace of mind that their warranty will cover them, regardless of their insurance situation," says Carrie Strom, Allergan's vice president of marketing, plastic surgery and regenerative medicine. "Out-of-pocket costs should not be an obstacle for a patient who needs treatment in the rare event that she is diagnosed with BIA-ALCL – especially if this coverage helps encourage early action."

ASPS President Jeffrey Janis, MD, says the hope is that all implant manufacturers will follow suit to help provide patient-centered coverage for this diagnosis, he adds that is not the ultimate goal. Rather, Dr. Janis says the Society will continue its robust advocacy work in trying to get the insurance industry to provide coverage for all patients who have been diagnosed with BIA-ALCL. Some carriers have largely denied coverage for surgery to remove implants and their capsules for BIA-ALCL, even though this is the recommended treatment, which can be curative if caught early.

"According to the FDA and World Health Organization, BIA-ALCL is cancer," Dr. Janis says. "Its treatment should be a covered entity. Period."

Allergan's updated warranty is another step in providing the necessary financial assistance to patients, he says, but it will not diminish the advocacy work being done on this front by ASPS.

"We will not relax our aggressive stance to help solve the long-term problem," Dr. Janis says. "The long-term solution is coverage for everyone."

Although the incidence of developing BIA-ALCL is rare, ASPS treats any procedure that may lead to a lymphoma or the death of a patient as a major concern and something that patients should be aware of prior to undergoing breast implant surgery. As of Jan. 1, the Society's PROFILE registry, which was established to track cases of BIA-ALCL, has documented 190 unique cases of the disease in the United States. Worldwide, nearly 513 unique cases have been reported, which includes 16 disease-related deaths. The lifetime risk for BIA-ALCL in previous epidemiological studies ranges from 1:1,000 to 1:30,000 for those with textured implants, based on sales data from the United States, Canada, Netherlands and Australia. The lifetime risk for developing BIA-ALCL for a smooth-only implant is zero currently.

ASPS provides information on BIA-ALCL at plasticsurgery.org/alcl as well as additional resources for members.

Dr. Clemens says that even though the disease is rare, the Society will continue its work not only to better understand BIA-ALCL but make sure that patients are protected in those rare cases when it does develop.

"This should be reassuring for women with implant or health issues that are hesitant to see their physician due to worries of out-of-pocket expenses," he says.

Disclosure: Dr. Clemens was a consultant to Allergan Corporation from 2013 to 2015.