On July 24, 2019, medical device manufacturer Allergan recalled dozens of models of textured breast implants. The implants have been associated with an increased risk of breast implant-associated anapestic large cell lymphoma (“BIA-ALCL”).
Allergan introduced the textured, silicone filled BIOCELL implants to the United States market in 2006, after the Food and Drug Administration (“FDA”) lifted a ban on silicone filled implants. Internationally the products have been on the market since the 1990s.
The texture on the outside surface of the BIOCELL implants is created by a process called “lostsalt”, wherein the manufacturer cures a layer of salt crystals under a layer of silicone and then washes away the salt. The result is a surface covered in tiny indentations. In this way BIOCELL is different from many other implants on the market that contain a smooth surface.
BIA-ALCL is not a true breast cancer, but rather a type of lymphoma. Lymphoma is a cancer of the immune system, and in cases of BIA-ALCL the cancer typically arises in the scar tissue and fluid surrounding the implant.
In 2011 the FDA released a report on BIA-ALCL after 27 cases of ALCL were identified and a link to breast implants was suspected — particularly textured implants like BIOCELL.
The FDA issued a safety communication in March 2017 after the World Health Organization (“WHO”) classified BIA-ALCL as a distinct disease. Again in September 2017 the FDA reported a total of 414 Medical Device Reports (“MDRs”) identifying cases of BIA-ALCL, nine of which resulted in death.
Lawsuits allege that Allergan, the makers of the BIOCELL textured breast implants, buried cases of BIA-ALCL in FDA reports. After averaging approximately 200 reported injuries related to breast implants per year, the numbers sharply increased to 4,567 in 2017 and 8,242 in just the first half of 2018.
Over this same time period the FDA changed its reporting requirements. “Alternative Summary Reports” (“ASRs”) that had been filed by Allergan bypassed the database that tracks medical device related injuries. These ASRs were formatted so that companies such as Allergan could report thousands of adverse events in a single filing, and with little detail. The ASRs were not typically accessible to the public, whereas other device failures reported to the FDA are.
This system allowed Allergan’s BIOCELL problems to fly under the radar for many years before public reports established an undeniable link between the textured implants and BIA-ALCL.
If you or someone you know is suffering from symptoms of pain and swelling following breast implant surgery, it is important to follow up with your doctor. You can read more about the FDA’s recommendations for patients here.
In addition to seeking medical treatment, you should consult an attorney to learn how to protect your legal rights. The attorneys at Egerton Law are accepting cases of BIA-ALCL after receiving textured breast implants made by Allergan and can consult with you at no charge. Call us today at336-814-2126 or fill out a web contact form for your free legal consultation.
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