Unfortunately, Bii and BIA-ALCL lawsuits are tricky. Meaning down right impossible.
Did you read that Prtesident Trump?????!!!!! This is unfair to the citizens of the United States of America. The protection of medical devises leaves ample room for corruption and for underhanded deals to be made, i'm sure, in some dark alley in the middle of hell.
I say that because my life has truly been hell for 13 years. Breast Implant Illness has stolen 13 years of my life from me. Something needs to change.
Implants are wrongfully protected by a ruling given by the Supreme Court via the case of Riegel vs. Medtronic (https://en.wikipedia.org/wiki/Riegel_v._Medtronic,_Inc. ). This gave federal protection to medical devise manufacturers because they are Class 3 Medical devises.
Healing Breast Implant Illness Reports:
"In the USA breast implant illess lawsuits are stalling because breast implants are Class III medical devices and are protected by USA preemption laws due to the 2008 Supreme Court case Riegel v Medtronic which gave broad federal protection to manufacturers citing that Class III medical devices are only accountable to the regulations and surveillance of the FDA who approves them for use."
"After Riegel, the only way to sue for a Class III medical device is to “identify conduct by the manufacturer which violated the PreMarket Approval or other specific requirements related to safety or efficacy of the device as set out by the FDA. If such conduct can also be stated in terms of a breach of a parallel common law duty (e.g, failure to warn under strict liability or negligence, manufacturing defect or breach of warranty), then it would appear the claim is not preempted. Alternatively, regardless of a specific violation, common law remedies are not preempted by general CGMP requirements.” from the Guide to Preemption of State-Law Claims Against Class III PMA medical devices. "
"Here is a drug and device lawsuit blog, which discusses why some of the latest breast implant cases have been dismissed."
"In order to overcome preemption laws broadly protecting Class III medical devices, a bill was introduced in 2017 to restore consumer’s rights to sue Class III medical devices that are currently preempted by federal protection due to Riegel. Please sign and support the Medical Device Safety Act H.R. 2164, which restores an injured consumer’s rights to sue Class III medical devices."
Medical Device Safety Act
This bill amends the Federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by the federal prohibition on state or local requirements regarding medical devices. This bill is retroactively effective and applies to pending civil actions.
Other sites that have information about Bii Lawsuits
Anita Laux v. Mentor Worldwide LLC
(December 29, 2015)
The case is Laux v. Mentor Worldwide LLC, No. 2:16-cv-01026-ODW(AGR), filed in Ventura County Superior Court and moved to federal court. She is represented by Robert A. Zeman (Law Offices of Robert A. Zeman) and Alan C. Milstein (Sherman Silverstein Kohl Rose and Podolsky).
News Articles about Lawsuits
Other Helpful Information
Does that sound right to you? It's wrong and needs to change.
I personally almost lost my life, went through 2 brain surgeries, a lumbar shunt surgery, I have suffered more than you can possibly imagined, my family has suffered, I have been on way to many medications, and spent hundreds of thousands of dollars.
That is the short list and I will probably have health ramifications for the rest of my life.
The funny thing is that before I explanted on May 16, 2019 I had 55 breast implant illness symptoms. Literally the day after I explanted 50 symptoms disappeared. I only have 5 left. It is a true miracle for me.
Breast Implant Illness is real. I am living proff that my Mentor Saline Smooth implants were making me sick. They were killing me slowly by poisioning me to death.
Why are breast implants still allowed to be implanted into human beings again? Oh, I know....MONEY.
If you would like to share your story please email me at