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What breast implants are being recalled?

Author

Andrew Vasquez

Updated on February 17, 2026

What breast implants are being recalled?

Allergan has notified the FDA that it will recall its BIOCELL textured breast implants and tissue expanders from the global market. These products have the same BIOCELL textured surface (shell), which is a unique surface used only by Allergan.

Subsequently, one may also ask, which breast implants are linked to cancer?

The U.S. Food and Drug Administration (FDA) recently announced that it has decided not to ban textured breast implants that have been linked to a rare cancer that grows in the scar tissue around the breast, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Furthermore, is there a recall on Mentor Breast Implants? The U.S. Food and Drug Administration announced a voluntary nationwide recall of certain types of textured breast implants on Wednesday due to their cancer risk. About 84 percent of BIA-ALCL cases are attributed to Allergan implants, opposed to other FDA-approved brands Mentor, Ideal and Sientra.

Similarly one may ask, which Allergan implants are being recalled?

The 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.

What are the symptoms of breast implant illness?

  • joint and muscle pain.
  • chronic fatigue.
  • memory and concentration problems.
  • breathing problems.
  • sleep disturbance.
  • rashes and skin problems.
  • dry mouth and dry eyes.
  • anxiety.

Do implants increase cancer risk?

“While breast implants do not increase breast cancer risks, there is some information about a possible link to ALCL that women should know,” says Dr. Heck. Anaplastic large-cell lymphoma (ALCL) is a very rare form of cancer of the cells of the immune system. It's not breast cancer, but ALCL occurs in breast tissue.

Which brand of breast implants are the best?

Best Brands for Breast Implants
  • Allergan Natrelle® Allergan is one of the world's largest breast implant manufacturers.
  • Mentor® Mentor® manufactures silicone and saline breast implants exclusively in the United States.
  • Sientra®
  • Ideal®

Is there a higher risk of breast cancer with implants?

“While breast implants do not increase breast cancer risks, there is some information about a possible link to ALCL that women should know,” says Dr. Heck. Anaplastic large-cell lymphoma (ALCL) is a very rare form of cancer of the cells of the immune system. It's not breast cancer, but ALCL occurs in breast tissue.

Do breast implants cause autoimmune disorders?

Women with silicone breast implants have reported a variety of autoimmune diseases, including scleroderma, rheumatoid arthritis, and lupus. Researchers have suggested that exposure to toxins in silicone gel may be the trigger that causes women who are predisposed to autoimmune disease to develop it.

Does silicone give you cancer?

This rare type of cancer has been found in the breast tissue of women with silicone (and also saline) breast implants, suggesting a possible link between implants and cancer. It's especially common with textured implants. Symptoms of BIA-ALCL include: asymmetry.

How do I know if my implants are recalled?

Symptoms of BIA-ALCL include persistent swelling or pain near the breast implant. People should monitor the area for any changes. Assessing people for BIA-ALCL typically involves a physical exam, imaging, and an assessment of the fluid or tissue around the breast implant.

Will Allergan pay for removal of textured implants?

As a result of this product withdrawal, if you and your plastic surgeon decide to remove your textured breast implants, Allergan will cover the cost of new, smooth replacement devices under the BIOCELL® Replacement Warranty.

What happens if your breast implants are recalled?

If you notice any changes in your breasts or have concerns, contact your health care provider. If you have the recalled implants, the FDA says you do not need to have them removed unless you are having symptoms such as lumps, pain, swelling, or asymmetry (breasts look different from each other).

How do I know if I have Allergan implants?

If you opted in, Allergan may be able to search its database to determine the type of implant(s) you have. IR-Medcom@allergan.com to see if they have information about your implant(s).

Do gummy bear implants ripple?

Most gummy bear implants feature a textured silicone shell, which prevents shifting or rotation of the breast implant within the breast pocket. Because gummy bear implants are filled with a firm semi-solid gel, they will not fold, wrinkle, or show ripples—common complaints with saline devices.

How often should implants be replaced?

The average saline or silicone implants may last anywhere from 10 to 20 years. However, many are removed sooner due to complications or cosmetic concerns. Up to 20 percent of people have their implants removed or replaced within 8 to 10 years.

What are gummy bear implants?

Gummy bear breast implants are one of the options available for breast augmentation. The term “gummy bear” is actually a nickname for these teardrop-shaped, gel-based implants. They're known to retain their shape better than other types of breast implants made from saline and silicone.

Should I replace my textured implants?

Should I have my textured implants removed? Because the risk of BIA-ALCL remains very low, current FDA recommendations for patients state, “If you have breast implants, there is no need to change your routine medical care and follow-up.”

Are Allergan implants safe?

Allergan manufactured smooth and textured implants until the FDA found the company's Biocell textured implants had a higher risk of breast implant-associated anaplastic large cell lymphoma. On July 24, 2019, Allergan announced a worldwide recall of its textured implants and advised surgeons not to use them.

Are Mentor implants safe?

FDA's warning letters to Mentor and Sientra both concern breast implant products first approved in 2013. FDA said it found several serious deficiencies in Mentor's post-approval study for its MemoryShape implant. The company failed to enroll the required number of patients in the study and had poor follow-up rates.

How long do Mentor implants last?

The average saline or silicone implants may last anywhere from 10 to 20 years. However, many are removed sooner due to complications or cosmetic concerns. Up to 20 percent of people have their implants removed or replaced within 8 to 10 years.

Should I have my implants removed?

“The longer you have breast implants, the more likely it is that complications will occur and you will need to have them removed,” it says. Mills urges women who have implants, whether silicone or saline, to get them checked on a consistent basis. He recommends changing one's implants about every 10 years.

Are mentor Siltex implants safe?

Mentor Siltex breast implants and anaplastic large cell lymphoma. Johnson & Johnson Medical New Zealand Ltd is notifying surgeons that these devices carry a risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).

How can you tell if breast implants are leaking?

Signs that your silicone implant has ruptured can include changes in breast shape and size, and increasing pain, firmness, and swelling over a period of weeks. Rupture can also cause capsular contracture. Silicone implant rupture that doesn't cause any noticeable symptoms is known as “silent rupture.”

Can Mentor implants leak?

Mentor shaped implants estimated rupture rate in the MRI cohort at 6 years was 2.1% for primary augmentation, 2.9% for revision-augmentation, 1.5% for primary reconstruction, and 0% for revision-reconstruction (11). The overall patient rupture rate (suspected and confirmed) in the MRI cohort was 16.4% (13).

Are Mentor implants FDA approved?

FDA's warning letters to Mentor and Sientra both concern breast implant products first approved in 2013. FDA said it found several serious deficiencies in Mentor's post-approval study for its MemoryShape implant.

Where are Mentor implants made?

Mentor Worldwide LLC is an American company that supplies surgical aesthetics products to plastic surgeons. The company is based in Santa Barbara, California. It produces one of two silicone gel breast implants.

What are Mentor implants?

MENTOR® MemoryGel® Breast Implants provide the soft, natural feel patients desire and are available in a wide range of sizes and profiles to fit the patient's body. Our implants are available in smooth or SILTEX® Imprinted Texture shells for multiple aesthetic and reconstruction possibilities.

Can breast implants last a lifetime?

Although breast implants don't actually expire, they aren't guaranteed to last a lifetime. The average saline or silicone implants may last anywhere from 10 to 20 years. However, many are removed sooner due to complications or cosmetic concerns.

What is the safest breast implant on the market?

Both saline and silicone breast implants are considered safe for breast augmentation and breast reconstruction. Research on the safety and effectiveness of both types of implants is ongoing.

How do I know when my breast implants need replacing?

5 Signs My Implants Need to Be Replaced
  1. Your Saline Implants Have Deflated.
  2. Your Silicone Gel Implant Has Ruptured.
  3. You've Developed Capsule Contracture.
  4. Your Breasts Are Asymmetrical or Deformed.
  5. You Want to Change Your Implant Size.

Can breast implants last 30 years?

Although breast implants don't actually expire, they aren't guaranteed to last a lifetime. The average saline or silicone implants may last anywhere from 10 to 20 years. However, many are removed sooner due to complications or cosmetic concerns.

What happens when implants are removed?

Once you've had the breast implants removed, your breasts will initially look deflated. It can take two to three weeks for the breasts to regain their volume. If you've had a breast lift after the breast implants have been removed, your breasts will not have a 'caved in' appearance.