Are Sientra textured implants linked to ALCL?

Question

I have sientra round, textured “gummy bear” implants. I know certain textured implants are linked to ALCL. Can you tell me if this is one of the brands linked to it?

Ryan Rebowe, MD · Answer

The current recommendation is to be screened regularly (i.e. yearly) with a physical exam from your board certified plastic surgeon for signs and symptoms of ALCL regardless of the brand of the device. That being said, that brand of implant was not the brand most associated with ALCL in the largest studies available.

Albert Ko, MD · Answer

Thank you for your question! Textured implants have been linked to ACLS. I would schedule a consultation with your surgeon to discuss your concerns. Best of luck.

Daniel Barrett, MD · Answer

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

Kirk Moore, MD · Answer

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.

Stephen M. Krant, MD, FACS · Answer

The overall risk of ALCL in breast surgery is related to the
type of texturing that is found in Allergan BIOCELL implants. The FDA has
recalled these prostheses, both saline and gel filled. However, the FDA did not
advise patients with Allergan BIOCELL textured breast implants to have
their implants removed unless they show symptoms of swelling and pain around
the implant. Also, a CD30 test can be done to rule out ALCL.
 Out of 573
cases of BIA-ALCL around the world, 481 of the patients were reported to have
Allergan breast implants. 
Good luck!

Jonathan Hall, MD · Answer

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.

Benjamin J. Cousins, MD · Answer

Thank you for your question and post. I am not aware of any cases of BIA_ALCL  that have occurred with the use of SIENTRA implants. It is best to continue to follow up with your plastic surgeon for periodic check ups. Sincerely,Benjamin J. Cousins MD Board Certified Plastic Surgeon

Tom J. Pousti, MD · Answer

I am not aware of BIA-ALCL (breast implant associated anaplastic large cell lymphoma) cases linked to Sientra textured breast implants thus far.  Of course, this does not mean that cases will not be reported in the future.   Some general information regarding BIA–ALCL may be helpful to you.The scientific literature now indicates that between one in 3800 women and one in 30,000 women with textured implants are at risk for developing BIA/ALCL (breast implant associated anaplastic large cell lymphoma).Although greater than 500 cases of BIA/ALCL have been confirmed worldwide, no cases have been reported in women exposed to smooth implant only.Whereas systemic ALCL is an aggressive metastatic disease, BIA-ALCL is more akin to cutaneous ALCL with an indolent course, often identified during the early stages of of the disease with lymphoma cells confined to a seroma or capsular tissue.
BIA/ALCL is most commonly detected during early stages of the disease with approximately two thirds of cases presenting as a delayed (greater than one year) implant related seroma, one third as a capsular mass, and a very small number with metastatic disease.  The mean time from implant surgery to diagnosis is approximately 10 years.  Patients typically present with a delayed seroma 8 to 10 years following implantation or, less commonly, with a capsular mass or systemic disease.Pathogenesis is likely to be multifactorial with current evidence recognizing the combination of chronic infection, biofilm formation, implant texturization, chronic inflammation, and time.
Current recommendations suggest ultrasound as first-line modality. With confirmation of seroma or mass, tissue specimens should be obtained via fine needle aspiration or biopsy.
 
 Current evidence suggests the disease localized to the capsule to be treated with surgery alone with removal of implants and complete excision of the capsule and any suspicious lymph nodes.   other modalities of treatment include chemotherapy, external beam radiation therapy and autologous stem cell transplantation. I hope this helps.

Steven Yarinsky, MD, FACS · Answer

Although any textured implant may be associated with ALCL, the most significant association has been seen with Allergan Natrelle textured implants.  Out of the current world wide reported approximately 500 breast implant ALCL cases from the millions of women who have had breast implants, I believe only 1 case may have had Sientra which makes it very rare indeed.  I still use textured Sientra implants for the majority of my patients and have had great results. I also follow the FDA and Sientra sites to re-evalulate the issues associated with Sientra textured implants.  At present, the US FDA has not recalled ANY of the current textured implants as they (FDA) continue to evaluate long term safety of these devices and have not found the link compelling enough to recommend removal of textured implants.

Edward J. Domanskis, MD (in memoriam) · Answer

BIA-ALCL has been found in association with textured implants from all the manufacturers that produced them.

Are Sientra textured implants linked to ALCL?

Answers (11)

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