Silicone Implants And Study Participation

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With the FDA approval of silicone breast implants last year came the post-approval studies agreed to by both implant manufacturers Mentor and Allergan.

The differences in the manufacturer studies were this: Allergan implants came with an option for women to enroll in studies, while Mentor mandated them for their MemoryGel silicone implants. That has now changed as Mentor received approval from the FDA to amend their study protocols to be voluntary.

However, a concern still exists. Although women are readily choosing silicone over saline breast implants roughly 90% of the time, they are reluctant to enroll in the studies.

If you are considering silicone breast implants, participation in the studies is voluntary, confidential and vital to continuing the data collection on the safety of silicone breast implants and the health and satisfaction of women who choose them. Take time to listen to your doctor as the process and value of the studies are explained. And if your doctor offers silicone but doesn’t share the study enrollment option to you, ask why. The only way to progress women’s rights and health regarding breast implants is to offer your experience in the form of data that can help to make valid scientific and statistical conclusions.

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