For nearly two decades, The Center For Restorative Breast Surgery (CRBS) has served as a trusted resource for the most up to date information and pioneering work in the field of breast care, breast cancer treatment, and reconstructive breast surgery. As growing concern emerges over breast implant safety, we are here to help you sort out the facts related to recent headlines, reports, and recalls. We are uniquely qualified, as experts in all forms of breast surgery, to help you navigate this complicated issue.


Listen to Dr. DellaCroce’s Latest Podcast with Breastcancer.org

In this podcast, Dr. DellaCroce discusses:

  • The Allergan textured implant recall
  • Illness linked to breast implants
  • The differences between textured and smooth implants, as well as the differences between silicone-filled and saline-filled implants and the theories as to why textured and silicone implants are linked to disease
  • What breast implant-associated anaplastic large-cell lymphoma is and how it is treated
  • What to do if you have an implant and are concerned

 


WHAT TO KNOW

There are 2 issues of current concern that have gained much recent global attention.

Question 1: Do Breast Implants Cause Cancer?

Be encouraged to know that implants have not been found to cause breast cancer per se, but there is emerging evidence of a link to a very rare form of lymphoma. It is called “Breast Implant Associated-Anaplastic Large Cell Lymphoma” (BI-ALCL). Most cases (~573 in the U.S. and some 700+ globally) have occurred in women with “textured” implants. There are a very few (~28) loosely confirmed reports of BIA-ALCL occurring in women with smooth implants but the majority of present information points to textured implants as the focus of concern. The reason for BI-ALCL development may be related to inflammation associated with the implants themselves or bacterial contamination trapped in the rough surface of textured implants, leading to chronic immune system stimulation and potential lymphoma development over time. There remains uncertainty in this area at this point. The good news is that BIA-ALCL is among the most curable forms of cancer. Of those who have developed the disease, most have been cured with implant removal and excision of the scar layer around them (“capsule”). In rare cases, the lymphoma may spread and require chemotherapy in addition to surgery. To date, statistics show that ~93% of women contracting BIA-ALCL are disease free at 3 years following treatment and there is a ~98.8% survival rate at 10 years. So far, globally, there have been ~33 reported deaths associated with BIA-ALCL.

Question 2: Do Breast Implants Cause Other Illnesses?

Breast Implant Illness has been a subject of study for 37 years. It was the primary reason silicone implants (both textured and smooth) were removed from the market in 1992 for 14 years. There is some evidence that silicone can stimulate the immune system and other studies refute that claim. In 2006 the FDA re-released silicone implants into the U.S. market after determining that the available data didn’t show a clear link to autoimmune diseases or other connective tissue disorders. A condition was included that required manufacturers to produce high quality data over the following 10 years to validate the FDA approval (called the Large Post Approval Study “LPAS”). No information from that registry was publically reported on until January of 2019 (Coroneos CJ, Selber JC, Offodile AC, et al. US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Ann Surg. Jan 2019;103(1):30-36). Once again, the question of an impact on the immune system and association with Sjogren’s disease, Rheumatoid arthritis, Scleroderma, Lupus and other health concerns was raised. Unfortunately the study revealed that data collected from the 2006 LPAS was not well assembled leaving unanswered questions after 13 years of study. In February of 2019, the FDA sent a letter to providers warning of the association of some of the studied implants with BIA-ALCL. In early March, the FDA issued a letter to 2 of the largest manufacturers warning that they had not properly complied with the LPAS requirements. Later that month, hearings occurred over 2 days in Washington about both BIA-ALCL and Breast Implant Illness.

If silicone implants are associated with autoimmune and connective tissue diseases, the cause remains unsettled. It may, however, be related to the theoretical cause of BIA-ALCL which is chronic inflammation from either low grade bacterial contamination of the implant (“biofilm”) or silicone exposure from implant leakage or “bleed” (a sweating of silicone through an intact outer shell).

Lab studies have revealed that the immune system may recognize silicone particles and silicone breakdown products. This does not prove that silicone implants cause illnesses such as rheumatoid arthritis, Lupus, scleroderma, Sjogren’s syndrome, or other connective tissue diseases, but it does suggest that silicone is not completely “inert” (invisible to the body). We further know that silicone “bleed” increases the chances of capsular contracture and that the sudden onset of capsular contracture can signal an implant leak. This suggests an inflammatory reaction to silicone exposure may occur, as inflammation is thought to be directly responsible for severe capsule formation. Some question of whether a genetic susceptibility to these conditions may also necessarily be a part of the mix has been raised. These facts may account for the ongoing associations we find in the literature but the relative rarity among women who’ve had implants placed. Unfortunately, at this point, we have no strong evidence that implants are associated with “breast implant illnesses” but we also haven’t been able to rule out a weak link.

Smooth walled, saline filled implants have not been the focus of concern in either BIA-ALCL or other illnesses.


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WHAT TO DO

BIA-ALCL:

Remember, that even if you have textured implants the risk of developing lymphoma is low. Presently we think the risk is between 1/1000 and 1/30,000 among women with textured implants. This means that, among those with other types of implants (the majority), the risk is likely lower.

The FDA has recalled textured implants manufactured by Allergan but both Mentor and Sientra continue to sell them in the U.S. market. The “recall” simply means that these implants are no longer available for use but there is no recommendation presently to remove textured implants in asymptomatic patients.

For those with implants of any type, be aware that you should continue your usual routine breast care, including mammograms, if indicated. For those with silicone implants, the FDA has recommended, since 2006, to have an MRI at 3 years post-implant and then every 2 years after to assess for implant leakage. You should continue annual post-implant well visits with your physician but if you notice any unexpected changes in breast shape, have onset of breast swelling, pain, fluid accumulation around your implants, lump development, or rash formation, you should immediately contact your physician as these symptoms may signal BIA-ALCL development.

If you are asymptomatic and decide to have your implants removed or replaced (despite the official FDA recommendation) you should seek the advice of a qualified, board certified Plastic Surgeon. You should know that implants may be removed without replacement and that choice may carry the downside of permanent breast disfigurement of a minor or major degree. You may also consider implants with smooth outer shells as a replacement in either a silicone or saline filled version. A third alternative is replacement with natural living tissue such as the APEX, DIEP, or SGAP flap procedures, which may provide an implant-free solution for breast volume restoration. All surgery carries risk and should be carefully considered in consultation with your surgeon before making any decision for intervention.

BREAST IMPLANT ILLNESS:

Be aware that this is less well sorted out. The suggestion of association is found in some reports and refuted in others. Our most comprehensive report from January of 2019, reveals some suggestions of statistical association of silicone implants with various illnesses. Unfortunately, the number of women who dropped out of the study and the self-reported questionnaires that were used to collect the data made the information somewhat unclear. Despite that, we cannot dismiss these conditions in women experiencing symptoms and an associated concern over their silicone implants. If you have questions or concerns about this, you should visit with and seek the advice of a qualified surgeon with expertise in all forms of aesthetic and reconstructive breast surgery.

In some cases, a referral to a Rheumatologist may be recommended for testing. If you decide to pursue implant removal or replacement, irrespective of testing, be aware of your options including removal without replacement, exchange to saline filled implants, or replacement with natural living tissue.

Above all else, know that these associations appear to be very rare and removal of your implants may or may not impact your symptoms. Careful study, expert consultation, and exploring your options thoroughly is encouraged.

As providers, we rely on manufacturers of medical devices to provide safe materials and to have them properly studied/approved so that we can deliver the highest quality of care to our patients. We expect no less, and are hopeful that the FDA and implant manufacturers will work to resolve these issues and keep the public/providers timely informed as more is learned about these issues. We are here to help you with updates and state of the art surgical solutions for those seeking care without compromise.