Newport Beach, CA, January 07, 2020 --(PR.com
)-- In December, 2018, the European Union asked Allergen to remove their textured silicone implants from the marketplace. Not until July, 2019, did the Federal Drug Administration (FDA) follow suit and Allergan withdrew these implants which are coated with a BIOFILM from distributing them and recalled them from plastic surgeons offices. The unprecedented reason for this is the confirmed association of textured breast implants, silicone and saline with Breast Implant Atypical Associated Large Cell Lymphoma (BIA-ALCL). The FDA last week issued a draft guidance on breast implant labeling with a “black box” warning.
BIA-ALCL has been diagnosed to date in 750 patients worldwide, almost all of them with textured silicone breast implants. Allergans, Mentors and Sientras textured breast implants are included in this number.
"The most common presenting symptoms of BIA-ALCL are fluid surrounding the implant (seroma), pain and feeling of a mass close to the capsule which envelops the breast implant," said Dr, Edward Domanskis, a plastic surgeon certified by the American Board of Plastic Surgery, who has extensive experience with breast implants and their removal.
"I have definitely seen an increase in requests for removing breast implant for fear of BIA-ALCL as well as Breast Implant Illness (BII) and I do an enbloc capsulectomy which is total removal of the capsule that surrounds the breast implant together rather than separately. This is the exact treatment that is recommended for BIA-ALCL."
The current lifetime risk of developing BIA-ALCL is about 1:3000 patients that have had textured breast implants. BIA-ALCL is diagnosed by ultrasound and examination of the fluid. Treatment consists of textured implant removal with its surrounding capsule or en bloc capsulectomy. Thirty three deaths have been confirmed worldwide.
The American Society of Plastic Surgeons (ASPS) has been in the forefront of trying to ascertain the etiology of this large cell lymphoma and is awarding grants for research into its etiology.
"This has frightened many of my patients, especially those with textured breast implants. I feel the number of patients that have textured breast implants developing BIA-ALCL will increase as more plastic surgeons and patients become aware of it," continued Dr. Domanskis who has offices in California and Florida. "Also, the number of women removing their breast implants will continue to concurrently rise," Dr. Domanskis concluded.
"I have quit using any textured implants, whether they are for the breasts, buttock, calves, and take the desires of my patients to explant breast implants and reconstruct their breasts after removal very seriously. Fortunately, we do have alternatives with our improved fat transfer techniques to regain some of the size that is lost with removal," finished Dr. Domanskis.