FDA Warns Two Breast Implant Makers About Lack of Long-Term Studies, Will Review Implant Safety

FDA Warns Two Breast Implant Makers About Lack of Long-Term Studies, Will Review Implant Safety

The FDA has sent warning letters to two breast implant manufacturers because the companies have not conducted the post-approval long-term safety studies that were required as part of the implants' FDA approval.
Mar 21, 2019.

On March 19, 2019, the U.S. Food and Drug Administration (FDA) sent warning letters to two breast implant manufacturers because the companies had not conducted the post-approval long-term safety studies that were required as part of the implants’ FDA approval.

The two companies are Mentor Worldwide LLC, of Irvine, Calif., which is owned by Johnson & Johnson, and Sientra, Inc., of Santa Barbara, Calif. Mentor makes MemoryShape, MemoryGel, and Spectrum silicone breast implants, as well as saline implants. Sientra makes Opus silicone breast implants.

Read the FDA announcement.

“Post-approval requirements are critical to ensuring the safety and effectiveness of the medical products we regulate, and we’ll continue to hold manufacturers accountable when they fail to fulfill these obligations,” said FDA Commissioner Scott Gottlieb, M.D. “We’re issuing these warning letters based on the manufacturers’ low recruitment, poor data, and low follow-up rates in their required post-approval studies. We expect these manufacturers to meet the pre-specified study requirements in order to ensure the collection of long-term data that can be used to inform long-term patient safety. Post-approval studies, along with other surveillance tools such as adverse event reports, registries, and scientific literature, allow the FDA to help ensure the safety of medical devices and protect patients.”

The implants could be taken off the market if the research isn’t properly done.


Lingering questions about implants’ long-term safety

Many women who have mastectomy to treat breast cancer go on to have one or both breasts reconstructed. There are two ways to reconstruct a breast:

  • using tissue transplanted from another part of your body (such as your back, belly, or thighs)

  • inserting an implant that's filled with saline (salt water) or silicone gel

A saline implant has a silicone shell that is filled with saline. Silicone gel implants are filled with firm silicone gel. They tend to feel softer than saline implants, and some women think the texture is more like natural breast tissue.

Implants also are used to cosmetically enlarge breasts.

According to statistics for 2018 from the American Society of Plastic Surgeons:

  • 313,735 implants were placed for breast enlargement

  • 29,236 implants that were placed for breast enlargement were removed

  • 19,149 breast implants that were placed for reconstruction were removed

The society’s statistics also show that 101,657 breast reconstruction procedures were done, but they do not differentiate between implant reconstruction and reconstruction using tissue from another part of the body.

The first implants were approved by the FDA in the 1960s. Since that time, many women with implants have reported health problems that some doctors think are likely caused by an autoimmune reaction to the implant, including chronic fatigue, flu-like symptoms, and hair loss.

More recently, a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Once a breast implant is in place, scar tissue forms around it, creating what's called a tissue capsule. Breast implant-associated ALCL (BIA-ALCL) usually develops in and around the tissue capsule, on average about 7 to 10 years after the implant is placed.

Lymphoma is cancer of the lymphatic system.

According to a January 2018 study, the estimated risk of BIA-ALCL in women with breast implants is:

  • 1 in 35,000 for women age 50

  • 1 in 12,000 at age 70

  • 1 in 7,000 at age 75

Because, overall, many more women have implants placed for breast enlargement than for breast reconstruction, a larger percentage of women reporting health issues related to implants had breast enlargement rather than reconstruction.


FDA to address potential safety questions

In a statement released on March 15, 2019, the FDA stressed that it is working to evaluate the materials in implanted medical devices, including breast implants.

Read the FDA statement.

“We’ve…heard from patients who are concerned that their implants may be connected to other health conditions that could be associated with their immune system’s response to these devices, resulting in symptoms like chronic fatigue, cognitive issues and muscle pain,” the statement said. “While the FDA doesn’t have definitive evidence suggesting breast implants are associated with these conditions, we’re looking to gain a fuller understanding of this issue to communicate risk, minimize harm and help in the treatment of affected patients. This topic will be discussed at our upcoming two-day public meeting of the General and Plastic Surgery Devices Panel on March 25 and 26, 2019, and will be informed by our ongoing assessment of the long-term health effects of various materials.”

The FDA is also coordinating two breast implant registries to learn more about how implants perform and interact with the body at the cellular and organ level.


What this means for you

Deciding whether to have a breast reconstructed after surgery to remove breast cancer is a very personal choice. If you’ve been diagnosed with breast cancer and are planning your surgery, you may decide not to have reconstruction, but it can be helpful to consider all your options.

If you are considering breast reconstruction with an implant, talk to your doctor about the risks and benefits of implants, including the differences between textured and smooth implants.

There are advantages and disadvantages to both implant reconstruction and reconstruction using tissue from another part of your body (autologous reconstruction). Implant reconstruction is considered easier up front but usually requires another surgery after 10 or more years. Autologous reconstruction is a more involved surgery, with higher rates of complications and a longer recovery time, but offers better patient satisfaction, according to a number of studies. You will need to decide what is right for you and your unique situation.

If you have an implant and wonder what to do about BIA-ALCL, the FDA recommends:

  • regular monitoring for symptoms of BIA-ALCL

  • if you have no symptoms of BIA-ALCL, there is no need to remove the implant and no need to change your routine medical care and follow-up

If you are experiencing other symptoms, such as chronic fatigue or muscle pain, that you believe are linked to your implants, talk to your doctor or surgeon right away. Together you can figure out if the implants or something else is causing your symptoms.

For more information, including types of reconstruction, the timing of reconstruction, and questions to ask your breast surgeon and plastic surgeon, visit the Breastcancer.org Breast Reconstruction section.

To talk to others considering reconstruction decisions, join the Breastcancer.org Discussion Board forum Breast Reconstruction.

And stay tuned to Breastcancer.org for the latest information on breast implant safety.

Editor’s Note: On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the FDA requested the recall. This article was updated on Aug. 29, 2019, with more current information about breast implant reconstruction.

Written by: Jamie DePolo, senior editor

— Last updated on September 15, 2022, 7:40 PM

Reviewed by 1 medical adviser
Brian Wojciechowski, MD
Crozer Health System, Philadelphia area, PA
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