Learn about the medical device industry's role in developing breast implants that meet and exceed the safety requirements of the United States Food and Drug Administration (FDA).
As one of the most innovative industries in the world, the medical device industry plays a critical role in today's health care, providing an array of treatment options and products that meet the needs of patients around the world.
While pharmaceutical companies develop and manufacture medicines to treat diseases or alleviate health conditions, medical device companies create and manufacture an array of products that perform a variety of functions that have become essential to health care and quality of life today. These devices range from thermometers to artificial limbs to pacemakers and medication delivery instruments. A breast implant is considered a medical device.
To ensure the safety of consumers and patients who utilize medical devices, the medical device industry is regulated by the United States Food and Drug Administration (FDA). The FDA is responsible for:
- Reviewing pre-clinical and clinical studies to confirm that there is sufficient data to support the safety and effectiveness of devices prior to wide use by the public
- Working with companies to develop and put in place standards for safety and effectiveness
- Auditing manufacturing facilities to ensure safety and effectiveness standards are being met and the products made are of the highest quality
- Monitoring devices after they become available for use by consumers and patients to continue to evaluate the performance of the devices
To meet the guidelines established by the FDA and to provide safe and effective medical devices to patients, the medical device industry continues to look for new ways to improve its products. Through advanced research and innovation, medical devices are constantly being updated to meet the health needs of consumers and patients.
Breast implants are no exception. Over the past two decades, breast implant manufacturers have been applying new technology and research to create more options for women who are considering breast implant surgery. In fact, the wide range of breast implant options available to women today is a result of past innovation and research.
Like many other medical devices, breast implants have evolved over the last two decades. Breast implant manufacturers spent many years applying research and results of laboratory testing to create breast implants that meet and exceed the United States Food and Drug Administration's (FDA) requirements.
As a result, women considering breast implant surgery have a wide range of options that have a proven record of safety and effectiveness. The evolution of breast implants can be seen in various components of the implant, including the thickness of the outer covering (also referred to as the "shell"), the type of filler material inside of the breast implant, as well as the shell surface. A plastic surgeon specialized in breast implant surgery can help a woman decide what option is best for her, depending on her body type and desired outcome for surgery.
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This Website last modified October 25, 2007.
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