Allergan Continues Educational Strategy Amid FDA's Report Linking Breast Implants To Rare Cancer

Following a Tuesday report by the Food and Drug Administration linking breast implants to anaplastic large cell lymphoma (ALCL), an Allergan plc Ordinary Shares AGN spokesperson told Benzinga the company is responding to the report with patient and public education.

“[We are] working closely with the FDA and global regulatory bodies to ensure that our products’ labeling documents include all information necessary for healthcare professionals and patients to make informed decisions,” Mark Marmur, director of corporate affairs, told Benzinga.

Allergan includes safety data, warnings and potential side effects in patient literature — including information on ALCL as a rare adverse effect. Marmur said the company is also contributing research and reports to advance the FDA’s knowledge of the disease and its association with silicone and saline implants.

“However rare, Allergan takes this disease seriously,” he said.

The FDA had been investigating the link since 2010, and though it released preliminary results this week, the Administration is still looking into an additional 350 reports.

Allergan shares were trading up 0.3 percent at time of publication.

Update: On Friday, a Johnson & Johnson JNJ spokesperson told Benzinga:

"We have no greater responsibility than to the patients who use our products, and our goal is to create medical innovations that help people live more active, healthy lives. We have every sympathy for anyone suffering from cancer. BIA-ALCL is a rare type of non-Hodgkin’s lymphoma that has occurred in a small number of the millions of women who have breast implants globally. We fully support the FDA’s efforts to gather additional data and study BIA-ALCL in patients with breast implants, and we will continue to work with industry groups, physician scientists and health authorities across the globe to better understand the associated risks and causes of BIA-ALCL."

Related Links:

Puma Biotech Crashes After Bad News About Its Last Cancer Drug

Breast Cancer Study Raises Issue of Severe Side Effects