Allergan Recalls Biocell Textured Breast Implants

Breast implant maker Allergan Inc. has issued a worldwide recall Wednesday for textured models because of a link to a rare form of cancer known as Anaplastic Large Cell Lymphoma (ALCL).

The move comes as the Therapeutic Goods Administration (TGA) finalises its decision on whether to ban textured breast implants in Australia.

In its submission to the TGA about the proposed ban, the Australasian Society of Aesthetic Plastic Surgeons (ASAPS) has called on the Federal and State Governments to roll out a national screening program for women with textured breast implants to identify those at risk of ALCL.

President of ASAPS, Dr Naveen Somia, said a government-funded screening program for women who have textured breast implants would allow those feeling nervous to be put at ease.

“The clinics of our ASAPS Members have received hundreds of calls in the wake of the news that textured breast implants could be putting patients at risk of ALCL.

“We are calling on the Federal and State Governments to fund a national screening program. The screening program would assess patients with textured breast implants for implant ruptures, implant capsule formation, or fluid or seroma around the breast implant. Screening patients is the only way to put them at ease,” Dr Somia said.

To date, ASAPS believes there has been very little support for patients who have textured breast implants.

“To support the roll-out of this screening program, ASAPS would like to see a social marketing campaign that provides accurate information and directs patients to the TGA website for reliable information,” Dr Somia said.

Another concern for ASAPS is the move by the TGA to classify breast reconstruction as cosmetic surgery.

Dr Somia said in doing so, would deprive vulnerable patients of a proven procedure that can aid in the mental and physical recovery of patients post breast cancer.

“In keeping breast reconstruction separate from cosmetic surgery, as is stipulated by the Medicare Item Numbers available to support this procedure, access to tissue expanders (which are microtextured) must be maintained. Tissue expanders are an essential component in breast reconstruction surgery, and many women would be significantly disadvantaged if these were not available. Tissue expanders are unlikely to be in situ for long enough (generally 3-12 months) to cause an ALCL if the hypothesis regarding causation is correct.

“Banning tissue expanders would be a backward step for these women who have already been through so much.

“Another vulnerable group who benefit from the use of textured breast implants are those who suffer from breast deformities due to radiation, burns, or congenital disabilities,” Dr Somia said.

Dr Somia said he would encourage patients who have experienced changes in their breasts to seek out a Specialist Plastic Surgeon to have a full clinical examination.

If you are concerned about your breast implants:

  • Speak to a Specialist Plastic Surgeon. They can guide you through the clinical review and assess if your breast implants are amongst those in question and recommend necessary tests and scans.
  • It is advisable to contact your original surgeon. They are best placed to tell you which implants you have, assess your risk and advise you appropriately.
  • For Australian patients, Medicare assistance is available after a definite diagnosis of lymphoma, MRI also has support once the diagnosis is confirmed.

“Specialist Plastic Surgeons dedicate themselves to acting in the best interests of their patients and take their responsibilities for patient safety seriously,” Dr Somia said.