A few months back, Allergan Inc. was asked to recall their textured breast implants. It was discovered that these implants were causing a rare form of cancer. According to an Illinois woman, Allergan knew that their implant might cause cancer. The proposed class action, filed on Friday claims that the company used an FDA loophole to bury cases proving their implants caused cancer. It wasn’t till 2017 that the FDA closed this loophole, however, the implants have been on the market since 2006.
The women who filed the suit did not actually develop cancer as of yet. However, these implants greatly increased her odds of being diagnosed with large cell lymphoma. She is asking Allergan to pay for implant replacement surgery. It should be noted that she’s not the only women to file a suit. Two women who actually did develop cancer launched suits back in August.
So how did these severe side effects get unnoticed by the FDA? In the U.S, manufacturers are supposed to report any and all safety concerns to the FDA. This is so it can be put on the Manufacturer and End User Facility Device Experience database. This is also known as MAUDE. In order to get away with not reporting these known side effects, the company filed these reports as “alternative summary reports.” These reports do not need to be given to the FDA. Simply put, Allergan used their Alternative Summary Reports to hide injuries that are required to be reported to MAUDE.
To show you how rampant this is, after the FDA closed these loophole on reporting, side effects for breast implants shot up from 200 to 8,242.
Have You Been Harmed From a Dangerous Drug?
If you have been injured from a harmful medical product? Dangerous drugs and medical devices harm thousands of people each year. If you have been injured due to a pharmaceutical or medical manufacturers negligence, you need an attorney to recover damages for the pain and suffering you have experienced. Villarreal and Begum know exactly how to fight these companies to get you the compensation you deserve. Call us today at our office or contact us online. We are available day and night to set up your free consultation.