31 May 2015

American Medical Systems (AMS)

american medical systems

American Medical Systems, also known as AMS is a company belonging to Endo International PLC, itself a global health care corporation with over 100 years in the industry.

AMS specifically has recently been involved in a vast number of lawsuits and settlements revolving around its transvaginal mesh products. These products are intended to treat pelvic organ prolapse and stress urinary incontinence but unfortunately they have been found to be largely defective – ineffectual at best and dangerous at worst.

If you have experienced any ill effects from your own use of AMS mesh products, then you may be entitled to compensation and should consider getting representation from a transvaginal mesh attorney who may be able to help you.

Endo International and AMS

Endo International has its global headquarters in Dublin, Ireland and employs many thousands of employees around the world. It specializes in the manufacture of pharmaceutical/medical products through four operating companies. These are:

  • American Medical Systems
  • Endo Pharmaceuticals
  • Paladin Labs
  • Qualitest

AMS is the company we are most interested however, as the arm of the company that specializes in pelvic health and continence difficulties. AMS has been mired in litigation over mesh devices designed to treat these conditions.
What is Transvaginal Mesh Implantation?

A transvaginal mesh implant, or vaginal mesh implant, is a device that is inserted into the vagina, often via the wall of the vagina with the aim of providing structural support for the interior tissues. Specifically, it is intended to support the internal pelvic organs and/or the urethra.

AMS has a number of vaginal mesh products to its name. These include:

  • Apogee Pelvic Floor Repair System
  • Apogee Systems with PC Coated IntePro Lite
  • Apogee Vault Suspension System
  • BioArc
  • BioArc SP Sling System
  • BioArc TO Subfascial Hammock
  • Elevate Anterior & Posterior Prolapse Repair System
  • Elevate with InteXen LP Prolapse Repair System
  • In-Fast Ultra Transvaginal Sling
  • Influence In-fast
  • In-fast Ultra
  • InterPro Y Sling
  • InteXen
  • Large Pore Polypropylene Mesh
  • MiniArc Precise Single-Incision Sling
  • Monarc Sling System
  • Monarc Subfascial Hammock
  • Perigee Pelvic Floor Repair System
  • Perigee Systems with PC Coated IntePro Lite
  • Perigree Vault Suspension System
  • SPARC (SUI only)
  • Spare Self-Fixating Sling System

Health Problems?
Unfortunately, these health products have been linked to a number of complications and serious side effects and have even been known to cause irreversible damage and permanent scarring.

The problems occur due to the implants causing erosion and shrinking, thus becoming more likely to erode the inside of the vagina as well as the organs that they are intended to protect. This results in severe discomfort, open wounds and the chance of infection.

More specifically, the symptoms include:

  • Bleeding
  • Constant pain
  • Pain during intercourse
  • Tightening
  • Vaginal shortening
  • Perforation
  • Infection

American Medical Systems products are among those implicated in these complications.
One patient who experienced discomfort has spoken about her experiences with AMS products specifically. Said Darlene, a 35-year-old mother of three, of her implant:

“I’ve been in so much pain since having this mesh implanted that I’m now addicted to the Fentanyl Patch. My husband and I can’t enjoy sex anymore and I don’t have the energy to spend much time with my kids. If I’m not in pain, I’m in a Fentanyl fog.”

Lawsuits and Settlements
Darlene is not alone in her experiences and there are in fact thousands of open lawsuits against AMS. The company was estimated to have liability for $159.8 million in 2013. The company agreed to settle a number of these cases in 2014, paying out $54 million total and then an additional $830 million. The company is actually the only one to have reached a large settlement and is believed to have paid out a total of $1.6 billion in doing so.

That said, it is expected that more cases will go to trial this year and in the foreseeable future. As is often the case with larger companies, Endo did not admit fault despite the huge number of claims against it.

AMS and Endo Pharmaceuticals are only one part of a much bigger story however. Other companies that have come under fire include Johnson & Johnson, ColoPlast, Boston Scientific and C.R. Bard. All these companies have faced trials and lawsuits relating to transvaginal mesh products and hundreds of thousands of women have come forward as victims.

What Happened?
One question many people may be asking at this juncture is what happened? How have such dangerous and ineffectual products been allowed to reach the market? The FDA have issued an alert against transvaginal meshes and have been quoted stating that the products are no more effective than simple stitches for treating the conditions they aim to treat.

The problem is in part due to the FDA’s own approval system for such products. These items are able to get approval by following a 501(K) system, which effectively means that they can be released without extensive testing – as long as there are similar products on the market.

This lack of rigorous testing meant that problems that emerged later during use of these products was not spotted until it was too late for the victims.

Getting Compensation
If you have been affected by any mesh product by American Medical Systems, then there is a good chance that you may be eligible for compensation. If you have experienced any discomfort, any psychological or physical trauma or any inconvenience as a result of these products not performing as advertised, failing or causing complications, then it is only right that the company responsible be held accountable.

Hundreds of thousands of women have successfully filed lawsuits against companies like AMS and while money can’t undo the hardship they have suffered, it can certainly help to alleviate some of the emotional and monetary strain that they may have caused.

If you would like to discuss your case further, then get in touch for a free, no obligation consultation. Time is limited to file your claim so please act promptly.

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