Will Endo Unload American Medical Systems Over AMS Mesh Problems?

Washington, DCIt was about three years ago that Endo International acquired American Medical Systems (AMS), the medical device manufacturer responsible for AMS mesh. Now, according to Business Monitor Online (9/2/14), Wall Street is abuzz with news that Endo has AMS on the block.

The parent company would not have been happy with the millions of dollars paid out this past April in order to settle some 20,000 lawsuits. That’s not just one AMS transvaginal mesh lawsuit, but thousands. Endo, according to various reports, had initially set aside some $50 million to settle lawsuits Endo had inherited through the acquisition of AMS. However, that settlement fund was increased to $830 million.

As it is, Endo paid $2.8 billion for the AMS mesh manufacturer in June 2011.

AMS tvm, or transvaginal mesh, is just one player in a shrinking manufacturing environment, given the problems with transvaginal mesh and a pending crackdown by the US Food and Drug Administration (FDA). The adoption of manufactured mesh for treatment of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) came with the benefit of faster healing times and shorter hospital stays over more traditional invasive surgical techniques.

However, once beyond those initial advantages, the benefits began to pale for many women, following the migration of the mesh and negative effects to internal organs and the uterus. Countless women have endured intense pain and suffering, and have been made to go through revision surgeries to have the AMS tvt (transvaginal tape) or mesh from other manufacturers removed or repaired, if revision surgery is even possible at all. Sometimes it is not.

The FDA, having approved transvaginal mesh through the 501(k) clearance protocol, no longer holds that transvaginal mesh is the first line of treatment, and to that end, last April, issued two proposed orders that would, if approved, reclassify AMS transvaginal mesh and mesh made by other manufacturers, from a Class II device with moderate risk to Class III high risk.

Such a reclassification would require manufacturers to submit Post Market Assessment and Analysis for after-market evaluation and effectiveness.

Some manufacturers have since abandoned TVM mesh altogether. Others are evaluating their ownership structures. Pundits are fairly certain that Endo will unload AMS sooner than later and cut its losses.

That’s little solace for any woman considering an AMS transvaginal mesh lawsuit. Mesh inserted arthroscopically for the repair of POP and SUI was introduced without a full complement of pre-market testing due to the fact mesh was already used for hernia repair. The 501(k) clearance allowed manufacturers to save millions in clinical trial costs, together with the opportunity to bring the technology to market sooner.

Now, the FDA is backpedalling on the file, manufacturers are baling and women are left to sue or suffer accordingly. The AMS legal fund of $830 million made available in April translated to about $40,000 per plaintiff.