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American Medical Systems Files its Position Statement Laying Out its Strategy in Court in Defective Mesh Lawsuits

Monarc by AMS for SUI

Monarc by AMS for SUI

April 9, 2012 ~ On Friday, April 6, American Medical Systems Inc. (AMS) of Minnetonka, Minnesota filed its Position Statement with federal court in the Southern District of West Virginia laying out its strategy in its defense of its synthetic surgical mesh used to treat female conditions of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

There have been 318 lawsuits filed against AMS which makes six synthetic meshes to treat SUI and five which treat POP, all of which remain on the market today.

AMS admits it’s been designing and manufacturing medical devices for men and women’s pelvic health since 1972 but denies the injured are seeking compensation because of a defective product or a failure to warn, the basis of a product liability lawsuit.

It says: “Rather, Plaintiffs are using the courts to second-guess FDA’s regulatory regime for clearing these treatment options in the first place, as well as to second-guess the surgeons who chose to prescribe them for a particular patient, even when those surgeons were aware of the risks.”

However, the Plaintiffs are alleging the mesh was defective and that AMS failed to adequately warn both doctors and consumers of the horrible complications the products can cause.

AMS MiniArc for SUI

AMS markets the following products for incontinence: SPARC, Monarc, BioArc, In-Fast, MiniArc, and MiniArc Precise.  AMS markets the following monofilament polypropylene mesh to treat POP: Apogee, Perigee, Elevate, Straight-In/Y mesh.

Federal Preemption

It’s interesting that the strategy by the Philadelphia law firm Reed Smith LLP is to hide behind the shield of the U.S. Food and Drug Administration (FDA). Most of the devices at issue in this case were simply rubber stamped by the FDA under the less rigorous, fast track 510(K) process. Under the 510(K) process, a manufacturer need not prove to the FDA that a proposed new device is either safe or effective. Because there was no FDA approval, which like drugs, requires clinical trials for safety and efficacy, AMS cannot shield itself from liability claiming the Plaintiffs’ suits are preempted by federal law.

Failure to Warn

AMS claims it is not liable for a Failure to Warn – one of the claims of a product liability case, because AMS said it did warn the surgeons in the product inserts. AMS claims its end user is the doctor and not the patient, therefore it did all it is required to do.

“Further, the learned intermediary doctrine (which will apply in almost all of these cases) precludes liability for failure to warn where, as here, the manufacturer warned the plaintiffs’ physicians about the risk of the harm alleged. Under the learned intermediary doctrine, the manufacturer’s duty to warn runs only to the physician prescribing the product at issue, and not directly to the end-user of its product, i.e., the patient. The learned intermediary doctrine recognizes that medical devices, such as the AMS products at issue, require a prescription from a medical professional and thus cannot be obtained without the independent judgment and decision-making of the patient’s treating physician, a “learned intermediary,” who then decides whether to prescribe the product based on his medical knowledge of the treatment options and the individual patient. The learned intermediary doctrine recognizes that physicians will exercise their own medical judgment and will appropriately discuss the risks and benefits of the surgical procedure with their patients. Accordingly, the manufacturer’s duty to warn is satisfied by providing reasonable warnings to the physician and not the patient.”

AMS Perigee for POP


AMS claims that the Plaintiffs’ negligence claims will fail because there is no evidence that AMS negligently designed or manufactured any of these products.

“Rather, AMS lawfully marketed its pelvic mesh products in accordance with the applicable FDA regulations for Class II medical devices and at all times acted consistently with, or exceeded, industry customs and practices with regard to the safety of its products.”

An expert panel meeting last September agreed that POP repair mesh should be upgraded from a Class II to a Class III medical device which would no longer allow these products to be cleared through the 510(K) process. Instead, they would be forced to file detailed applications for approval including a sufficient showing of safety and efficacy. Class III mesh would have to be evaluated for safety and efficacy as a drug is evaluated. The panel did not change any regulation of the SUI repair mesh, but may reclassify a mini-sling mesh.

So far there are 318 pending lawsuits filed against AMS from federal courts in 35 states that have been consolidated before Judge Joseph R. Goodwin in the Southern District of West Virginia in Multidistrict Litigation No. 2325. #

Learn More:

MDL Transfer Order Feb 7, 2012

MDL No. 2325 Calendar of Events



  1. Michelle Edenfield says:

    In regard to the Failure to Warn, AMS could always add the implanting surgeons. Further, with regard to AMS Negligence, AMS had/has an obligation to be certain a medical device is safe for whomever intended, their guarantee to the surgeon is implied. The mere fact that these devices were to be implanted via the vagina, when the vagina is not a steril area, is negligence enough. Come on, any high school science student knows that you cannot implant something via the vagina and have it be steril.

  2. Kathy says:

    Well, the surgeons should have warned us of the risk, I for one asked clearly “is this safe” and was told ” oh yes, very .” Why are they going to reclassify a Miniarc sling? The very overlooked problem is they sold a product that is like a cheese grater inside our fragile bodies, via the Vagina, only tested on Cadavers and didn’t consider removal.

    In sexually active women that now have erosion. They can blame doctors and the FDA but they must take responsibility at some point.

  3. Cher says:

    Thanks to AMS bladder mesh I now have a debilitating disease scleroderma. This has surely taken the best of me. No,energy thyroid med.,no sex,bloated on each lung.adhesions scar tissue..compression pumps cpap machine..nabulizer machine..very intimidating to daughter with special needs who couldn’t bare seeing the mom that ran nonstop.She moved out 30 going on 12″ This is a death sentence. I now have a RA,a heart,lung.derm,gastr specialist. appt after appt matter test. Just exhausted. So be it for easy in out quick fix..ithe sparc mesh ruined me for life. Zero mess to eight. Can’t see right or think correctly. Damn mesh ..damn AMS…

  4. Cher says:

    I have heard zero from atty but AMS settled??

  5. Donna Zucker says:

    I had seen 3 urologists/urogynecologists. Cystoscope, urethroplasty, and then March 5,2014, mini arc sling which I only found out was implanted a few weeks ago (yes 2yrs later!). I had bladder pain, urgency, frequency, pressure. The 2nd one is the one who put it in. She said she wasn’t going to because I have fibromyalgia. Then when I found out it’s in I called and her nurse said when she was in the OR, she did a test where they fill your bladder and see if it leaks, and they said it did. The problem is I diagnosed MYSELF using the Internet just early sept this yr 2015 that I actually have interstitial cystitis, which has the same symptoms. Also, I was diagnosed with ovarian cancer 6mths later, so I had the cancer when she did the surgery. I asked her over the phone if she had done a pelvic exam while I was one the table, and she stuttered nnoooo, noon, I wasn’t in that area. The symptoms I had are also the symptoms of ovarian CA. I was post menopausal and on hormone replacements so she should have, and if she had she would have found it earlier. The cystitis was caused by a seizure med I was on. Great, huh? Now it may also be because I’m pre diabetic, thyroid is off, cortisol very high, and my blood tested poss for 4 types of mold and candida, I had 3 mold issues fro broken pipes in 1yr, which can also cause freq urination, as well as diabetes, and NO ONE drew any blood to rule out other diseases or disorders. I finally went to a naturopath an hour away who is finding all these things. Since June 2016, I’ve had to pack my groin with ice 3-4 times because of extreme pain, with high dose of pain meds. I have constant burning in my pelvis, and this other dr I just saw who is a colorectal surgeon, and female, said it’s not the mesh, it’s dry vagina post menopause. I’m not so sure, because it hadn’t burned before and I’ve been post for yrs. I just now found out it’s the AMS sling. I want it out before there are anymore problems. I still owe the hospital for the anesthesia from this surgery and an ER visit from the night after the surgery because I couldn’t.t urinate. They cathedral me 2 times and we’re getting a return of long white stringy mucous and blood (I saw it). That’s $1,300 that I’m in collections for. Who do I go to and what do you do? Any suggestions?

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