On July 24, 2019, the U.S. Food and Drug Administration took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. The FDA’s decision was based on medical research that demonstrated a direct link to cancer in women who had Allergan’s implants that was not seen in other textured implants.
Specifically, the FDA found that of the 573 new cases of BIA-ALCL, 481 (83%) of them were attributed to Allergan’s products. The FDA concluded that the “risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers….”
If you have undergone breast implant surgery with a textured implant and/or have been diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), you may be entitled to legal compensation from the product’s manufacturer, Allergan, Inc. Contact us today for a free, no-obligation case evaluation. Any information you share with us is confidential.
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Breast implants are medical devices that are implanted under the breast tissue or under the chest muscle to increase (augment) breast size or to rebuild (reconstruct) breast tissue after mastectomy or other damage to the breast.
There are two types of breast implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have silicone outer shells that vary in size, shell thickness, shell surface texture, and shape (contour).
Saline-filled breast implants contain a silicone outer shell filled with sterile salt water (saline) solution. Some are pre-filled and others are filled during the implant operation. Saline-filled implants come in different sizes and have either smooth or textured shells. The FDA approved saline-filled breast implants for breast augmentation in women age 18 or older and for breast reconstruction in women of any age.
Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age.
Breast implants are not intended to be lifetime devices. The longer that a woman has implants, the more likely it is that she will need to have surgery to remove or replace them. The most frequent complications experienced by breast implant patients include capsular contracture (development of internal scar tissue around the implant), implant rupture, scarring, illness, pain, and infection. Based on medical findings, the FDA has determined that one of the most serious risks of breast implants is the very low but increased likelihood of being diagnosed with anaplastic large cell lymphoma (ALCL). At this point in time, there is no established distinction in risk of developing ALCL between those who have saline implants and those who have silicone.
Anaplastic large cell lymphoma (ALCL) is a rare cancer that affects cells of the immune system. While ALCL can rarely occur in the breast, it is not a cancer of the breast tissue. Rather is a blood cancer. Most cases of ALCL in the breast, occur in women who have had breast implants. This is sometimes referred to as Breast Implant-Associated (BIA)-ALCL. It is important to note, that BIA-ALCL seems to be associated with textured-surface breast implants or tissue expanders.
Medical researchers believe that when the tissue around an implant becomes inflamed, fluid can build up, damage cells, and cause cancer to develop in the fluid. If BIA-ALCL progresses, it can invade other tissues, including lymph nodes. This is why recognizing symptoms (pain, swelling, lumps in the breast or armpit) is so critical to getting a timely diagnosis and treatment.
Charles E. Boyk Law Offices, LLC
Charles E. Boyk Law Offices, LLC