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Covidien Transvaginal Mesh Settlement Covers 11,000 Injury Cases

vaginal meshThere’s very good news for some or all of the 11,000 plaintiffs who’ve filed claims against Medtronic’s Covidien unit for injuries caused by its transvaginal mesh implants. The medical device manufacturer has agreed to settle an undisclosed number of claims against it for an unspecified amount.

The Covidien transvaginal mesh settlement was filed on June 23 in West Virginia federal court amid mounting pressure from the sheer volume of lawsuits that have been filed against Covidien and other transvaginal mesh manufacturers. Tuesday’s regulatory filing noted that as of June 1, there were about 11,300 transvaginal mesh claims against Covidien.

100,000 lawsuits claim painful, permanent injuries

Transvaginal mesh devices have been prescribed for women who suffer from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Once implanted, the devices are designed to help provide needed support to weakened or damaged pelvic walls. But an estimated 100,000 transvaginal mesh lawsuits have already been filed by women alleging that they’ve suffered painful and in some cases, permanent injuries after the devices were implanted.

The most common reported injuries include erosion of the mesh through the vagina, infections, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.

The lawsuits of many of these women detail having to undergo additional surgery to either attempt to remove the mesh or repair damage to their tissues. It has also been reported that in many cases, removal of the mesh has proven impossible because the mesh has become either partially or completely embedded in the woman’s organs.

In 2011, the Food & Drug Administration (FDA) issued a safety communication referring to its serious safety concerns with transvaginal mesh devices and stated that complications caused by the devices are not unusual. At this time, the FDA is still considering whether to reclassify these devices from Class II (moderate risk) to Class III (high risk), warning that in some cases transvaginal mesh devices may be more harmful than alternative methods for treating pelvic organ prolapse.

Covidien transvaginal mesh settlement a precursor for tens of thousands

Many of the current 100,000 lawsuits in state and federal courts have been centralized into seven multidistrict litigations (MDLs) overseen by US District Judge Joseph R. Goodwin. The common allegations in these suits are inferior or inadequate design, the use of substandard materials, and inadequate testing of the product before bringing it to market.

Covidien’s agreement to settle may well have been prompted by Judge Goodwin’s urging companies to settle rather than fighting claims in court. CR Bard, another manufacturer, had asked the judge for a delay in its trial over the mesh devices but was refused. Judge Goodwin told Bard attorneys that he could not “imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum.”

Some device makers such as Coloplast and Endo have also taken Judge Goodwin’s advice. In March 2014, Coloplast said it would pay $16 million to settle lawsuits over vaginal-mesh inserts, spurring talk of a global settlement.

In 2014, Endo’s American Medical Systems set aside $1.6 billion to settle about 40,000 filed and unfiled claims, Reuters reports. However, Johnson & Johnson, Boston Scientific, and CR Bard are still contemplating settlements.

  1., Covidien settles the score in more than 11,000 vaginal mesh cases,

  2., Covidien Agrees to Settle Some Cases Over Transvaginal Mesh Devices,