Is Bigger Better? Mentor Receives FDA Approval to Conduct Clinical Trials for Larger Breast Implants

Farzana Akkas, MSc and Diana Zuckerman, PhD, National Center for Health Research

Recently, Mentor, a company that makes breast implants, received FDA approval to initiate clinical trials to study the safety and effectiveness of their new and larger memory gel breast implants. Mentor’s memory gel implants are made of an outer silicone shell, filled with clear silicone gel. The largest implants currently available in the U.S. are 800cc, which is about the size of a cantaloupe. The study is enrolling mastectomy patients starting in April 2016 and will evaluate the safety of implants that range in size from 750cc to 1,445cc.

Although silicone gel breast implants have been sold in the U.S. since the 1960’s, they were not approved by the FDA until 20061, after taking them off the market for cosmetic patients in 1992 due to safety concerns. The approval in 2006 was based on research done by breast implant manufacturers such as Mentor and INAMED (a company that was sold to Allergan). Since the approval, all breast implants have been found to increase the chances of developing a rare form of lymphoma (cancer of the immune system) known as anaplastic large cell lymphoma (ALCL). 2

Although research linking systemic health consequences and silicone breast implants gives conflicting results, local complications such as rupture, pain, capsular contracture, disfigurement and infection are an obvious complication from breast implants.  Capsular contracture is the most common complication of breast implant surgery, followed by hematoma (blood clot), infection and pain.3, 4 Rupture is considered inevitable if the woman doesn’t replace aging implants.5 The FDA advises women to undergo breast coil MRI tests to check for rupture of silicone gel breast implants starting 3 years after surgery and every 2 years after that.6 This is because most silicone gel breast implants do not show any signs of rupture for several years (this is also known as silent rupture). However, breast coil MRIs are expensive and not usually covered by health insurance.7, 8

The concern about larger silicone gel breast implants, such as the ones being tested by Mentor, is that an enormous amount of silicone could leak into the woman’s body if the implant ruptures. Mentor justifies that larger implants are necessary because larger breasted women who have been diagnosed with breast cancer need them to be consistent with their normal breast size.

As obesity has become more common, more mastectomy patients have requested larger breast implants  It is particularly likely because women who are overweight are more likely to develop breast cancer. However, they are also more likely to have a recurrence of breast cancer.  For that reason, obese women who have had breast cancer should be helped to lose weight in order to lower their chances of breast cancer coming back after the surgery.  Replacing a woman’s breast with a very large implant could encourage her to remain overweight, rather than to lose weight.

If these larger breast implants are approved, however, some women who have never had a mastectomy might choose them for cosmetic reasons.  This would be especially dangerous because research shows that breast implants can interfere with breast cancer screening mammography and mammography can cause breast implants to rupture.9

The bottom line is that there are still many unanswered questions and conflicting studies on the safety of breast implants. Being able to offer a better size range to larger breasted mastectomy patients certainly does not adequately justify the need for larger breast implants when the negative health consequences are considered. It is important to continue conducting unbiased research to study the complications of breast implants and how implant manufacturers can improve the integrity of their implants to avoid or decrease incidents of complications.

All articles are reviewed and approved by Diana Zuckerman, PhD and other senior staff.

  1. FDA Update on the Safety of Silicone Gel-Filled Breast Implants. Center for Devices and Radiological Health U.S. Food and Drug Administration, June 2011. Web. 1 Mar. 2016 <http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM260090.pdf>.  
  2. Silicone Gel-Filled Breast Implants. U.S. Food and Drug Administration. Web. 01 Mar. 2016. <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm063871.htm>.  
  3. Headon, H., Kasem, A., Mokbel, K. Capsular Contracture after Breast Augmentation: An Update for Clinical Practice (2015). Archives of Plastic Surgery, 42, pp. 532-543.  
  4. Molitor, M., M?š?ák, O., Kalinová L., Krajcová A., M?š?ák J. The History and Safety of Breast Implants (2014). Acta Chirurgiae Plasticae, 56(1-2), pp. 15-19.  
  5. Molitor, M., M?š?ák, O., Kalinová L., Krajcová A., M?š?ák J. The History and Safety of Breast Implants (2014). Acta Chirurgiae Plasticae, 56(1-2), pp. 15-19.  
  6. Risks of Breast Implants. U.S. Food and Drug Administration. Web. 01 Mar. 2016. <http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm064106.htm#Rupture_Silicone_Gel-Filled>.  
  7. Collis, N., Litherland, J., Enion, D., Sharpe, T. D. Magnetic Resonance Imaging and Explantation Investigation of Long-Term silicone Gel Implant Integrity (2007). Plastic and Reconstructive Surgery, 120(5), pp. 1401-1406.  
  8. Handel, N., Garcia, M.E., Wixtrom, R. Breast Implant rupture: Causes, Incidence, Clinical Impact, and Management (2013). Plastic and Reconstructive Surgery, 132(5), pp.1128-1137.  
  9. Daskalaki, a., Bliznakova, K., Pallikarakis, N. Evaluation of the effect of silicone breast inserts on X-ray mammography and breast tomosynthesis images: A Monte Carlo simulation study (2016). Physica Medica.