Allergan shrouded in controversy for rare cancer-causing breast implants

Park Gi-taek  Published 2019.12.31  10:20  Updated 2019.12.31 14:09


- Top 10 pharmaceutical stories in 2019 ⑨

This year was a year where the word "safety" was particularly highlighted in the healthcare industry. The N-Nitrosodimethylamine (NDMA), a potentially carcinogenic substance, which caused a ruckus after being detected in valsartan-based antihypertensive treatment last year, was further extended to ranitidine and nizatidine. Earlier this month, the medical community was startled when the carcinogenic substance was found in some metformin products, which is the most widely used diabetes treatment in Korea. Also, the importance of drug safety was further highlighted through Allergan's breast implant safety issue and Kolon Life Science's Invossa incident. Along with safety issues, Korea Biomedical Review looked back on major issues that have affected the medical industry this year. - Ed

Allergan caused a hot controversy this year after worries that its artificial breast implant may result in rare types of cancer.

It was first triggered when the U.S. Food and Drug Administration issued a safety notice on the possible side effects of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) in patients who received breast implants in February.

The Ministry of Food and Drug Safety here also demanded that Allergan voluntarily recall its breast implants and tissue expanders in August.

The ministry also instructed doctors to stop using of Biocell textured breast implant product, also known as Natrelle, while ordering them to return any leftovers to the importers and inform patients of the risk of developing BIA-ALCL.

BIA-ALCL is rare cancer associated with the immune system and is different from breast cancer. It usually occurs several years after the implant surgery, while symptoms include persistent swelling or pain near the breast implant. Most BIA-ALCL cases are known to occur in patients with textured breast implants.

As concerns about the artificial breast implants grew, the academia stressed that while patients need to take caution, there is no need for excessive anxiety.

"The recall was issued because the epidemiological study showed that Allergan's implants had a higher incidence of BIA-ALCL compared to other company's implants,” Korean Society of Plastic and Reconstructive Surgeons (KSPRS) said. “There is no need to be overly anxious about the disease BIA-ALCL.”

BIA-ALCL is very rare and can be cured without chemotherapy or radiotherapy if the implant and encapsulation are appropriately removed at the onset, the association added.

“The FDA had also recommended that patients that received textured breast implants do not have to remove their implants unless they show special symptoms,” the association said.

As of now, there have been two reported cases of BIA-ALCL in Korea.

Allergan has issued a compensation plan aiming to compensate for the full medical expenses for patients with confirmed BIA-ALCL.

Compensation measures are targeted in three different ways -- for patients with confirmed BIA-ALCL associated with rough surface breast implants, patients with suspicious symptoms, and patients who remove breast implants as a precaution.

For BIA-ALCL confirmed patients, the National Health Insurance benefit would be applied. At the same time, Allergan will support any additional deductibles, including expenses not included in the national health insurance plan, up to $7,500.

Also, any patient care fees exceeding this amount will be additionally provided for individual patients. The company will also offer a Natrelle silicone gel smooth-type breast implants to patients free of charge for the rest of their lives.

If the doctor suspects BIA-ALCL in a patient and orders a diagnosis, Allergan will also provide about 1.2 million won ($1,000) for medical expenses per visit for tests such as pathology and ultrasound.

Pathology tests for diagnosing BIA-ALCL include CD30, ALK, and cytological tests, while Allergan will financially support one or more of these tests.

For patients who do not have prior BIA-ALCL symptoms but want to replace their breast implants, Allergan will provide them with its smooth-type breast implants free of charge.

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