BANGKOK – Thailand’s Food and Drug Administration on Tuesday announced the recall of rough-surfaced silicone breast implants after an American supplier reported a link to cancer.
FDA secretary-general Tares Krassanairawiwong said the supplier Allergan Co ordered an immediate recall their silicone implant.
It has been reported that about 800 patients worldwide with the silicone implants have been diagnosed with non-Hodgkin’s lymphoma.
Almost 84 per cent of the confirmed cases have been associated with the Allergan implants, with at least 12 confirmed deaths associated with Allergan implants.
Patients in Thailand and from Abroad Received the Implants
“Since 2011, approximately 29,000 silicone implants have been supplied to hospitals and clinics in Thailand.
14,000 of the rough-surfaced silicone were implanted into patients from Thailand and abroad.
Hospitals and clinics that used them in breast implant surgery were informed of the recall,” Dr Tares said.
“Recipients with swollen or deformed breasts should see their doctor immediately.”
However, there was no need to panic because the occurrence of cancer was very low, he said.
The silicone breast implants were available under the trademark Natrelle.
They were produced by Allergan Costa Rica SRL in Costa Rica, and the owner is Allergan Co of the United States.
The recall covers Natrelle series ST-410 MF, 120, ST-410 MM, and 110.
Prof Apirak Chuangsuwanit, of the Society of Plastic and Reconstructive Surgeons of Thailand, said the relationship to the product and cancer remains unknown.
Breast implants come in both textured and smooth formats, with the former resembling sandpaper.
Making it less likely to move around inside breast and change position.
Allergan said the recall, however, does not affect its Natrelle smooth or Microcell breast implants and tissue expanders.
Breast Implant Recall: What You Need to Know
The pharmaceutical company Allergan has recalled all BioCell textured breast implants at the request of the US Food and Drug Administration (FDA) because they have been linked to a rare type of lymphoma: breast implant associated anaplastic large cell lymphoma (BIA-ALCL). The products included in the recall are:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recall also includes tissue expanders. These are balloon-like sacs that are slowly expanded with salt-water to stretch the skin so the permanent implant can be inserted later. They include:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
The recall does not mean all women with these implants should have them removed. The FDA says the surgery is not worth the risk unless a woman is having symptoms. Signs and symptoms of BIA-ALCL may include lumps, pain, swelling, and asymmetry (breasts look different from each other).
Implants linked to a type of lymphoma
The FDA first reported a possible link between breast implants and anaplastic large cell lymphoma in 2011. Evidence showed this rare type of lymphoma occurs more often in women who have implants with textured surfaces compared with smooth surfaces.
Since then, more evidence has strengthened the FDA’s understanding of this link. In announcing the recall, the FDA stated that the overall incidence of BIA-ALCL appears to be low, but the risk is greater than previously thought. The risk appears to be more closely linked with Allergan BioCell implants than with other types of textured implants.
- 573 cases of BIA-ALCL and 33 deaths have been reported around the world, up from 457 cases and 9 deaths in February 2019.
- Of the 573 cases of BIA-ALCL, 481 have been attributed to Allergan implants.
- Of the 33 deaths, 12 patients had an Allergan breast implant at the time of their BIA-ALCL diagnosis, and one was from another company. The manufacturer of the other 20 patients’ implants is not known.
What to do if you have a Recalled Implant
- If you already have breast implants, the FDA advises you to continue your regular, routine medical care and follow-up. If you notice any changes in your breasts or have concerns, contact your health care provider.
- If you have the recalled implants, the FDA says you do not need to have them removed unless you are having symptoms such as lumps, pain, swelling, or asymmetry (breasts look different from each other).
The FDA advises women considering breast implants to talk with their health care team about the benefits and risks of textured-surface vs. smooth-surface implants.
Source: Cancer.org, Bangkok Post