FDA Finalizes Black Box Warning for Textured Breast Implants Linked to Cancer
A Korean woman who developed a rare type of cancer after receiving Allergan’s textured breast implants is suing the manufacturer and its management in the United States. According to a news report, the female patient in her 40s received breast augmentation surgery seven years ago. Recently, she had severe swelling in one breast and visited a plastic surgery clinic. She was diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in August. This woman was reportedly the first case of BIA-ALCL in Korea.
The news report states the woman was at stage 2 when diagnosed and is receiving chemotherapy and radiation. She suffered from skin rashes, headaches and body aches for several months but did not have any specific symptoms around her breast. She sought medical attention after her breast suddenly swelled, which is when she was diagnosed with BIA-ALCL.
Ineffective Compensation Policy
The multinational pharmaceutical giant, Allergan did not sell too many textured breast implants in the United States because of the heightened risk of BIA-ALCL. In July the company recalled all of its textured breast implants after the cancer risk was made public. However, it did aggressively sell them in Korea starting in 2014, leading to scores of thousands of victims. An attorney for the plaintiff said victims from Korea are in the process of filing a class-action lawsuit in the U.S. against Allergan.
While Allergan did open up a compensation fund for victims, the company has so far only agreed to pay to replace the implants and said it would not pay for the surgery, which could cost patients thousands of dollars. It also placed a condition that by accepting the replacing of the implants, Allergan would then have immunity against the lawsuits. Due to this condition, few victims ended up accepting Allergan’s compensation, which from the beginning, was ineffective.
If You Have Been Affected
According to the Food and Drug Administration (FDA), women should be watching for persistent pain and swelling around the implant. This is because the cancer doesn’t develop in the implant but in the fibrous scar tissue that forms around the implant. If you see any swelling in the breast or changes, you should contact your plastic surgeon right away. Doctors recommend women who have implants – whether they are textured or smooth – should schedule an annual visit with their plastic surgeon for a checkup.
If you have developed cancer as a result of receiving Allergan textured breast implants, please contact an experienced product defect lawyer who will help you seek compensation for damages such as medical expenses, lost income, cost of surgery, permanent injuries and disfigurement, pain and suffering and emotional distress.