Information About the Allergan Textured Implant Recall

At Gallatin Plastic Surgery the safety and comfort of our patients is our first priority. Recently Allergan, a company that produces many cosmetic and medically necessary products including breast implants, announced a decision to remove textured breast implants from the worldwide market. This decision was made because of an extremely rare disease that is associated with this type of implants called breast implant associated anaplastic large cell lymphoma (BIA-ALCL). While textured breast implants are used much less commonly in United States than the rest of the world, the shape of these implants is sometimes preferable and used occasionally.

There are several important points to remember about this recall:

  • Around 500 confirmed cases have been reported in the world since this disease began being recognized within the last decade. This puts the risk of developing this disease at around 1 in 30,000 patients, although the rarity of the disease makes it difficult to determine the exact incidence.
  • Smooth breast implants do not appear to have any risk of development of ALCL.
  • In order to give some perspective on the likelihood of developing this disease, here are some comparisons:
    • A woman in the US has a 1 in 8 lifetime risk of developing breast cancer.
    • The odds of being struck by lightning in your lifetime is around 1 in 3000 – this is around 10 times the likelihood of developing BIA-ALCL if you have textured breast implants.
    • The risk of dying from a blood clot in the US (deep venous thrombosis and pulmonary embolism– not including stroke) is about 1 in 4000 per year.
  • The breast implant associated version of this disease appears to be much less aggressive than the naturally-occurring form. Usually, when the implant and surrounding scar is removed, the disease goes away. However, the disease can be fatal.
  • Symptoms of the disease include a fluid collection around the implant (called a “seroma”) that usually occurs several years after the implant was placed. However, most patients who develop a fluid collection years after implant placement (which is rare) still do not have BIA-ALCL.
  • Patients with textured implants who do not have any signs of any problems are not being advised by the FDA or Allergan to have their implants removed or any additional testing or imaging.
  • If you are uncertain of what type of implant you have, you will find this information on your implant card. If you are still unsure, your plastic surgeon likely has this information on file.

Please do not hesitate to contact us if you have any questions or concerns about breast implants or anything else about plastic surgery.  We take part in the Breast Implant Registry to help further research on breast implants, which are the most studied medical devices in history, and are committed to passing along the most thorough and up-to-date information available.

 

Dr. Jarred McDaniel

Gallatin Plastic Surgery

300 North Willson Ave., Ste 300-C

Bozeman, MT  59715

(406) 577-2346

info@gallatinplasticsurgery.com

 

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