8 Minute Read:
Have you heard about the FDA recall of Allergan™ BIOCELL® textured breast implants? Are you wondering what this news is about and what action you need to take if you have these implants?
Dr. Ali Sadeghi and the team at the Sadeghi Center for Plastic Surgery are committed to educating and protecting the public, which is why we’ve created this informative page about the Allergan™ recall and what you need to know. While we have never used this implant in our practice, we realize that many others did, and it is crucial for patients to know what to do if they have this particular implant.
Please read the following information and reach out to us with any questions or schedule a consultation if you’d like to discuss your options for replacement.
What Is the Allergan™ BIOCELL® Textured Breast Implant Recall About?
The U.S. Food and Drug Administration (FDA) has requested a specific type of textured breast implant manufactured by Allergan™ be recalled. The recall is due to the link to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system. Following the FDA request, Allergan™, a pharmaceutical company based in Dublin, Ireland, launched a worldwide recall of their BIOCELL® products, including Natrelle® and Natrelle INSPIRA™ saline and silicone breast implants. The recall also includes some tissue expanders used by patients before having breast implants. Allergan™ had already stopped selling their BIOCELL® textured implants in Canada and Europe.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement.
The FDA reported that of 573 BIA-ALCL cases, 481 are attributed to the Allergan™ implants. At least 12 of the 33 patients who died had the Allergan™ BIOCELL® implants.
The FDA does not recommend that women with Allergan™ implants remove them if they are not experiencing symptoms. However, these women should be on the lookout for symptoms, such as unexplained pain and swelling, and should see their physician immediately if they have any concerns.
Abernethy said the FDA has been closely monitoring the issue since the agency first identified a potential link between breast implants and ALCL in 2011. Since then, the FDA has made an effort to raise awareness and encourage reporting of all cases so that the agency can continue to monitor the implants. Abernethy said that after the development of new science and evidence, the FDA concluded that it is necessary to recall the Allergan™ products to protect public health. She added that the FDA will continue to monitor the incidence of BIA-ALCL across both textured and smooth implants as well as other devices used in the breast.
Researchers are not sure why textured implants may be linked to ALCL. Binita Ashar, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, said it is not known
Dr. Ali Sadeghi is a double board-certified surgeon who specializes in reconstructive surgery, cosmetic, and plastic surgery. As a leader in the field of reconstructive breast surgery, Dr. Sadeghi performed thousands of surgeries throughout his career. In doing so, he has earned the reputation as one of the best plastic surgeons in the nation.
As founder and medical director of the Sadeghi Center for Plastic Surgery, Dr. Sadeghi constructed a practice that focuses on compassionate, personalized, and complete care of his surgery patients. Dr. Sadeghi and his exceptional team strive to provide a welcoming environment for all patients.
The large majority of implants used in the U.S. have a smooth surface. Textured devices have sandpaper-like surfaces to make them less likely to move around inside the breast. These comprise roughly 10% of the market, with the Allergan™ products accounting for less than 5%.
In 2018, a Dutch study estimated the risk of anaplastic large cell lymphoma in women with breast implants at:
- 1 in 35,000 at age 50
- 1 in 12,000 at age 70
- 1 in 7,000 at age 75
According to the FDA, the risk of BIA-ALCL with Allergan™ BIOCELL® textured implants is about six times the risk of BIA-ALCL with textured implants from other implant makers.
It’s important to remember that BIA-ALCL is not breast cancer.
BIA-ALCL is usually found in the scar tissue and fluid near the breast implant. However, in some cases, the cancer can spread throughout the body. While the chance of a woman developing BIA-ALCL is very low, a diagnosis is serious, since the disease can be deadly, especially if not diagnosed and treated early on.
If you already have breast implants, the FDA advises you to continue your routine medical check-ups. Regularly monitor the area around your implants for any changes, and if you notice any changes, contact your doctor.
However, even if you have the recalled Allergan™ implants, you do not need to have them removed unless you are having symptoms such as pain, lumps, and swelling. The FDA also recommends that women considering breast implants talk with their doctor about the benefits and risks of textured vs. smooth implants.
Evaluation for BIA-ALCL usually involves a physical exam, imaging, and assessment of the tissue or fluid around the implant. It is critical to undergo an evaluation to diagnose BIA-ALCL, since a diagnosis may change the type of operation that should be performed.
According to the FDA, the majority of women diagnosed with BIA-ALCL see their physicians because of fluid build-up around the implant about 7 to 10 years after the textured implant was inserted. There have been no reported cases of BIA-ALCL being diagnosed in women with smooth implants.
The most common symptom, local swelling due to fluid build-up, is experienced in 86% of patients.
Other symptoms include:
- A mass near the implant (8–24% of women)
- Enlarged lymph nodes (4–12%)
- A rash, fever, and capsular contracture (less than 5%)
If you have experienced any of these symptoms, contact a qualified surgeon as soon as possible. If you are considering getting breast implants, talk to your doctor about the risks and benefits.
Complete List of Recalls
Recalled Allergan™ products include:
- Natrelle saline breast implant styles 168, 363, 468
- Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
- Natrelle 510 Dual-Gel styles LX, MX, FX
- Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
- Natrelle Inspira breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
- Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
- Natrelle 150 Full Height and Short Height double lumen implants
- Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
- Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
- Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T
The recall does not impact the Natrelle smooth or Microcell breast implants and tissue expanders.
Contact Dr. Sadeghi
For the past 16 years, Dr. Ali Sadeghi has established a surgical practice committed to skillful and compassionate care and cutting-edge surgical methods. Dr. Sadeghi has built a reputation as a leader in the field of reconstructive breast surgery and is well known for delivering amazing results for women who undergo reconstructive, restorative, or aesthetic procedures. While Dr. Sadeghi has never used Allergan™ implants in his practice, he believes that all women who have had them should be aware of their risks.
At the Sadeghi Center for Plastic Surgery, located in Metairie, Louisiana, Dr. Sadeghi offers patients two types of implants (saline and silicone) with a variety of shapes, styles, materials, and orientations.
If you are considering breast implants, Dr. Sadeghi will help you to choose the right implants for the look you want. Depending on the size and shape of implants you desire, Dr. Sadeghi will use a surgical approach that will minimize scarring.
Types of Breast Implants Offered
Saline breast implants are filled with a sterile saltwater solution. Saline implants are empty during surgery. Once they are inserted under the skin, they are filled. This type of implant typically looks less natural than silicone implants. An advantage of a saline implant is that if it leaks or bursts, the issue will be noticeable, and the saline solution will be absorbed naturally into the body without harm.
Silicone implants, on the other hand, are filled with silicone, a cohesive gel that feels similar to breast tissue. Silicone implants come pre-filled and require a slightly bigger incision in the skin for placement. If a silicone implant leaks, it may not fully collapse as saline implants do, so you will need to schedule follow-up appointments with Dr. Sadeghi to check on the implant.
Interested in Learning More?
For more information on Dr. Sadeghi and the Sadeghi Center for Plastic Surgery, contact us through our website or call today at 504-322-7435.