BIA-ALCL Special Announcement – May 3, 2019

Posted May 03, 2019 in Home, Patient Safety

Textured Breast Implants will remain available in the U.S. for now.

Textured Breast Implants will remain available in the U.S. for now.

Lately, it seems there is a new announcement every month regarding BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma). Clinical data continues to be collected and compiled, in no small part thanks to the efforts of the members of the ASPS (American Society of Plastic Surgeons) and the ASAPS (American Society for Aesthetic Plastic Surgery). BIA-ALCL is rare, so there are not many cases available to evaluate.

Most Breast Implants Are Smooth

There seems to be an association between the roughness of texturing and the presentation of BIA-ALCL. Most cases of BIA-ALCL are associated with textured implants. Most breast implants used are smooth. In the US database, all patients with BIA-ALCL had textured breast implants at one point in their history. The question remains why is there an association. Unfortunately, in order to answer this question, more data is needed.

The French Rejection

Last month, as reported here in the San Francisco Plastic Surgery Blog, the French authorities (ANSM) decided to withdraw all macrotextured breast implants and polyurethane-coated breast implants from the market. The decision was criticized by many medical professional organizations for being one-sided, based on incomplete information and neglecting to take into account the benefits that textured implants offer to selected patients.

The U.S. Confirmation

Yesterday, the U.S. FDA spelled out the reasons why textured breast implant will remain on the market in the U.S.. Excerpts from the announcement are included below, but first, what do we currently know, and what are these decisions being based upon?

Pros & Cons of Textured Breast Implants

Everything we do as doctors has pros and cons, but the decision to weigh risks and benefits should remain individualized and between doctor and patient. When there is clear evidence that a device or a medicine causes more harm than good, only then does complete removal from the market seems warranted.

Smooth breast implants are a good alternative (if not superior) in most cases. In my practice, I use smooth, round, breast implants more than 90% of the time. However, there are two situations in which textured implants may provide an advantage: breast reconstruction and capsular contracture.

Textured Implants and Breast Reconstruction

After a mastectomy or for some congenital breast abnormalities, shaped breast implants provide a superior cosmetic result. In these cases, the lower pole of the breast is tight and resists expansion. By placing an implant which is fuller at the bottom, the lower pole can be filled more than the top, creating a better shape and a more normal appearance.

The concept is simple; however, keeping the implant from spinning is not. The original breast implants from the 1960’s used fuzzy patches on the back to anchor them and prevent rotation. The problem was the implant would tear at the attachment and leak.

Internally stacked implants attempted to provide the same cosmetic results without the external patches. These where normal silicone gel filled implants, but had smaller implant placed inside them to fill the lower pole. The internal implant was anchored inside the main implant to keep extra filling in the bottom, creating the desired tear-drop shape. The result were beautiful. Unfortunately, the internal fixation caused the same problem as the original external patches, and the implants ruptured at ten times the usual rate.

Today’s shaped implants are textured to help prevent rotation. The rough surface attaches to the surrounding tissue a bit like velcro, making it less likely to spin. This too is not perfect, but to date, it’s the best method we have to keep the big end of the implant in the lower part of the breast. Without texturing, the teardrop shaped implant spins, giving up-side-down looking breasts, dilating the pocket and causing implant malposition.

Texturing and Capsular Contracture

Texturing has also been shown to reduce the incidence of Capsular Contracture. Capsular Contracture is caused by contraction of the capsule that normally holds the breast implants in place. As is tightens the breast can become firm and the breast implants can move. Revision surgery is usually necessary to reposition the breast implants and soften the breasts. Textured breast implants have a lower risk of capsular contracture, but come with a higher risk of visual rippling (wrinkling). More about capsular contracture and its treatment can be found on my website’s Capsular Contracture Page and Breast Augmentation Revision Page.

U.S. Food & Drug Administration

Yesterday, the FDA announced that textured breast implants would remain on the U.S. market.

The announcement is framed by the opening paragraphs:

  • There has been a growing discussion in recent months around the safety of certain breast implants, with regulatory agencies around the world weighing the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s an issue that has been a priority for us at the U.S. Food and Drug Administration since 2011 when we warned women that the available information at the time indicated that there is a risk for women with breast implants, especially those with textured implants, for developing this disease.
  • Since that time, we have worked diligently to fill the gaps in knowledge, such as evaluating the body of available evidence regarding the safety and risks of breast implants, including concerns specific to textured implants and the risk of BIA-ALCL. The agency has undertaken several steps to better understand this issue, including an in-depth review of post-approval study data, medical device reports, scientific literature and breast implant-specific registries, and public discussions.

Steps the U.S. FDA is Taking

The FDA announced specific steps they will be taking to better understand the disease and share the information collected.

  • First, we will take steps to improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants. We are also looking at ways to incorporate product ingredient information into the labeling in a way that is easy for patients to understand. The FDA would work with stakeholders, including patient groups, on the content and format of any labeling changes proposed or recommended by the FDA, which could include a boxed warning and a patient decision checklist, and would work with manufacturers on implementing any changes to the information they provide to health care professionals and patients, including labeling.
  • We will continue our regular updates about the known global medical device reports for BIA-ALCL, as we have done since 2011. Moving forward, we plan to also regularly communicate information we receive through medical device reports about systemic symptoms experienced by patients with breast implants. We provided information at the two-day advisory committee meeting on medical device reports we’ve received that mention systemic symptoms described by some as breast implant illness, and we plan to continue sharing the numbers of medical device reports on these symptoms.

The FDA has been in the process of changing how adverse events are reported. In the past summary reporting was allowed, but this is being phased out for breast implants, and all medical devices.

  • Moving forward, breast implant manufacturers will be required to file individual medical device reports that will be publicly available in MAUDE. For past data received through summary reporting, the agency will also be making this data, including alternative summary reports for all devices under the program, publicly available in the coming weeks.

New FDA Reporting Requirements

The FDA has also recognized the importance of the American Plastic Surgery Societies registries.

  • Partnering with registries, such as the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILEExternal Link Disclaimer), which collects real world data on patients with BIA-ALCL diagnoses, and the new National Breast Implant Registry (NBIRExternal Link Disclaimer), which collects real world data on the safety and performance of breast implants, is one way in which we seek to gain greater insight and more comprehensive information about women’s experiences with breast implants.

The FDA Addresses the French Rejection

The FDA also commented on the restriction and banning of textured implants in Europe.

  • A few of our international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL. In those markets, there are textured implants that are not marketed in the U.S. and where the use of textured implants is much higher, sometimes as high as 80% market share. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
  • The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low. We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants.
  • Taken together, we believe these efforts to improve communication and focus on evidence generation will contribute significantly to improving the safety of breast implants and want to share that many of these efforts are already underway. We are committed to making a difference for women’s health and will continue working towards ensuring we understand the benefits and risks of these devices, and that women have the most complete information available to make important breast implant decisions.
  • The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.