Dubai: UAE plastic surgeons have confirmed receiving notification of a recall for Allergan breast implants after they were linked to breast cancer.
Pharmaceutical company Allergan reportedly ordered a worldwide recall of their textured ‘BioCell’ implants this week following a warning from the US Food and Drug Administration.
The implants have been linked to a higher incidence of anaplastic large cell lymphoma breast cancer.
The FDA reported 573 cases of the cancer and 33 deaths this year. Of those 573 cases, 481 were attributed to Allergan implants, and from 33 deaths, 12 were confirmed to have Allergan implants at the time of their diagnosis.
Dr Sanjay Parashar, a leading plastic surgeon and CEO of Cocoona Aesthetic Surgery Centre in Dubai, confirmed that he had received notification of the recall.
“The plastic surgery society received the notification,” he told Gulf News. “The textured breast implants from Allergan have been completely withdrawn after the notification. Luckily, for us we have never used this product. We use another breast implant, which is the Gold Standard in implants, so fortunately our patients are not affected by it.”
He added: “There is no need to panic, regular screening and review are part of our protocol for breast implant patients. We follow a six monthly review for the first two years and then an annual screening and review after that with an MRI scan after five years and the completion of 10 years. This protocol makes both the doctor and patient very vigilant.”
Dr Arun Karanwal, a medical oncologist from Prime Hospital, said: “Most women who undergo breast implant surgery following a mastectomy have the choice of smooth or textured breast implants.
“Textured implants, as their name suggests, have a rough outer surface like sandpaper, which helps the implant attach easily to the surrounding body tissue, making it move less and preventing it from going out of shape. Besides that, there is also less movement, which means there is less scar tissue formation.
“Anaplastic lymphoma is a kind of cancer that results in the abnormal build-up of T-cells in the lymph nodes,” he added. “It has a high cure rate. In case of textured breast implants it is likely to develop in the scar tissue. Although it is asymptomatic, patients who have the implant and complain of fever, pain, swelling or collection of fluid at the implant site, must be screened.”
Gulf News contacted the representatives of Allergan in the UAE but they were not available for comment.
Products recalled by Allergan
• Natrelle Saline-Filled breast implants: styles 163, 168, 363 and 468.
• Natrelle Silicone-Filled breast implants: styles 110, 115, 120, TRL, TRLP, TRM, TRF, TRX, TCL, TCLP, TCM, TCF, TCX, TSL, TSLP, TSM, TSF and TSX.
• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants: styles 410FM, 410FF, 410MM, 410 MF, 410 FL, 410 ML, 410 LL, 410 LM, 410 LF, 410 FX, 410 MX, 410 LX.
Tissue expanders that have been recalled
• Natrelle 133 Plus Tissue Expander.
• Natrelle 133 Tissue Expander with Suture Tabs.
