Breast Implant Answers: Technology and Innovation

While each manufacturer of breast implants has its own protocol for testing the devices, all companies are subject to the same standards set by the FDA and are dedicated to the ongoing testing of their breast implant devices to provide women with the highest quality of options available.

Allergan puts its breast implants through a battery of tests to ensure that the medical devices have optimal durability and longevity. For example, Allergan tests a representative sample of the company's breast implants for durability and strength in a laboratory setting by exerting on them nearly 55 pounds of force repeatedly, up to 6.5 million times.

In comparison, a routine mammogram exerts approximately 30 pounds of force on a woman's breast and women typically do not need to undergo more than 50 or so mammograms during their lifetime. Today's silicone gel-filled breast implant designs, however, have been tested to withstand more than 25 times the force of a normal mammogram without failure.

All breast implant manufacturers, including Allergan, follow, and are monitored to ensure they meet, required government regulations and strict procedures throughout all stages of breast implant manufacturing. These government regulations apply to the production, handling and shipment of materials and final silicone gel-filled breast implants.

Specifically, all manufacturers of medical devices must provide proof that their products are produced under Current Good Manufacturing Procedures (CGMP). These procedures ensure that all medical devices are manufactured under a strictly controlled environment, and have established a validated process to ensure the consistency and quality of each device.

Breast implant manufacturers also maintain and exceed government-required security measures for shipping and manufacturing procedures, to guarantee that all silicone gel-filled breast implants meet the highest possible quality standards. These security measures include the use of tamper-evident seals, putting precautions and safeguards in place to prevent possible product tampering or product damage, and maintaining a tracking system for breast implants.

Patricia McGuire, M.D.
Plastic surgeon, Parkcrest Plastic Surgery, St. Louis, Missouri, and clinical instructor of surgery at Washington University School of Medicine.

Like other medical devices, silicone gel-filled breast implants have evolved over the past two decades. As a practicing plastic surgeon for more than 16 years, I have witnessed first-hand the technological innovation as it relates to these devices. With the recent approval of silicone gel-filled breast implants, there is now a complete range of options for women today considering implant surgery – options that work best for their individual needs, and in accordance with their desired surgery expectations.

The breast implants of today are designed with similar safety and efficacy standards, but now offer varying degrees of cohesiveness/firmness, shapes and textures to meet the individual needs of all my patients. Advancements, such as a thicker, reinforced shell and a more cohesive silicone gel filler, are just a few of the examples of how these devices have evolved and continue to provide safe options for patients.