A Demand To Investigate the Safety of Breast Implants

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Back in the 1990's, the Food and Drug Administration banned silicone breast implants due to public concerns about health risks including: cancer, connective tissue diseases and autoimmune diseases/disorders. On November 17th, 2006, the FDA allowed silicone gel breast implants to go back on the market with specific criteria and to collect study data on if the devices were safe to be fully approved. These criteria included prior informed consent and a consent form had to be signed by each patient and their plastic surgeon prior to implant surgery. Mentor Worldwide and Allergan were required by Federal Law to conduct large studies and to monitor long term health and safety outcomes during this time frame so it could be determined if the devices were safe to be fully approved. To this current day, Mentor MemoryGel silicone gel and Allergan Natrelle silicone gel are still not fully approved as well as other silicone gel breast implant manufacturers.There has never been a study conducted on saline breast implants to date and only a handful of study data on the safety of silicone gel implants, despite the hundreds of thousands implanted per year.

We demand an immediate investigation on the safety of these devices and we demand all study data released immediately to the public that shows the safety of these devices, as the public is not aware to this data.

On July 24, 2019, Allergan announced a recall of the Biocell textured implants the FDA requested on a voluntary basis. Prior to this voluntary recall,  other countries had already banned these devices due to the increased risks of developing cancer.

As a governmental agency, your salaries and benefits are tax dollar allocated to payout for your role to protect the American people and our tax dollars support this protection.  This is far from reality and us victims have paid the price by our tax dollars paying out for something we did not receive.  We have paid the price by trusting the FDA to regulate safe devices and Congress to do their jobs in this process.  We demand immediate investigations into both agencies and immediate financial investigations of the government employees that have supervised specifically all silicone and saline breast implant regulatory processes since 1993, when the ban occurred.

We demand the immediate investigations into the lobbying monies paid to lobby to the FDA via the Federal forms that Congress and Mentor Worldwide paid for lobbying "specifically silicone breast implants".  We demand the immediate investigation on why the Office of Liaison Counsel MDL 926 was part of this lobbying monies.  We demand the immediate release of these financial statements and the reasons why the FDA was paid these monies. 

I am signing this Petition because I have been harmed or a love one has been harmed by these Class III medical devices.