Are Sientra textured implants linked to ALCL?

Dear aahk26,
no, there are no links between Sinetra textured implants and ALCL. There are some reports linking Allergan BIOCELL  implants with ALCL. However FDA didn't require removal of implants in asymptomatic patients.
Daniel Barrett, MD

BIA-ALCL and SIentra Implants

 

On July 24, 2019 The FDA released a safety communication to update the current understanding of BIA-ALCL and called for the voluntary recall of the higher risk devices.  This referred to the more aggressively textured Allergan BIOCELL  implants.  This recall did not include the textured devices from Sientra or Mentor

 

The FDA has been made aware of 573 cases worldwide of Breast implant associated anaplastic large cell lymphoma (BIA-ALCL). This is a little lower than previously reported because some cases had been reported more than once and the FDA has reviewed each and removed duplicates. Where the manufacturer was listed the FDA reports that 90.5% of the world cases involved an Allergan implant, 7.1% a Mentor implant and 1% a Sientra implant.

         So this is thought to be most common with the more aggressively textured devices (Allergan BIOCELL texture) and significantly less common with the less aggressively textured implants (Mentor and Sientra)

     Researchers in Australia and New Zealand where more textured implants have been used for a longer period of time report a 1:3,345 risk with Allergan BIOCELL and a 1: 86,029 risk with Mentor SILTEX texture.

 

Even with Allergan BIOCELL the risk is low enough that the FDA is not recommending the routine removal of these implants unless a patient is having symptoms.

 

The most common symptom is a late ( more than one year after surgery) collection of fluid around the implant, called a seroma.  This would show up as swelling.  But symptoms may also include pain, a lump in the breast or lymph node in the armpit, rash, fever, weight loss or unexpected changed in the breast shape, including asymmetry.

 

If you do notice any suspicious changes you should make an appointment to see your plastic surgeon. He or She will perform and evaluation and order the appropriate tests to determine if any treatment is indicated.  This typically involves having some of the fluid removed and sending it to be tested for a biologic marker called CD30.

 

Women who develop BIA-ALCL are usually cured by removing the implant and the scar tissue (breast implant capsule) surrounding it. Some patients may require additional treatment such as radiation or chemotherapy.

 

The use of texture with breast implants is controversial.  5% of breast implants used in the US have texture, which  can decrease shifting of an implant and reduce the need for additional surgery. 

 

     At the recent Breast Surgery Symposium in Atlanta in 2019 some surgeons have stopped using texture entirely.  But many surgeons are still using the less aggressively textured implants such as Mentor or Sientra after careful discussion with their patients because there is a risk of reoperation with smooth implants which may be less stable in patients whose breasts may be more prone to malposition.

I only use textured Sientra implants and have not heard anything about it being linked to ALCL. Keep doing check ups with your Plastic Surgeon on regular check ups.