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FDA Says Pelvic Mesh Products High Risk

Thousands of lawsuits have been filed over the past six years against various manufacturers of surgical mesh products used to treat conditions such as pelvic organ prolapse and stress urinary incontinence in women.  These lawsuits challenged the safety and effectiveness of these products, after years of reports of women experiencing pain, bleeding, infection and other complications caused by the mesh implants.  Often, the complications resulted in women having to undergo multiple surgeries to repair or remove the mesh product.  Now, the United States Food & Drug Administration (FDA) is finally getting on board with those of us who have been stating for years that these products are neither safe nor effective.

In July of 2011, the FDA concluded that women who were surgically implanted with vaginal mesh products had more complications than those who underwent traditional surgery involving stitches.  At that time, the FDA issued an update on serious complications associated with the transvaginal placement of mesh for the condition known as pelvic organ prolapse (POP).  This condition occurs when the tissue that holds the pelvic organs in place becomes weakened or stretched, resulting in the organs prolapse or bulge into the vaginal area, causing various and serious complications.  In its 2011 update, the FDA informed doctors and patients that serious complications associated with the use of transvaginal mesh products for repair of pelvic organ prolapse were “not rare.”

This week, the FDA took a stronger stand against the use of surgical mesh products to repair POP in women, classifying transvaginal mesh products as “high-risk” medical products and subjecting them to additional regulatory scrutiny.  Previously, these products were considered “moderate-risk” products.  Now, the manufacturers of pelvic mesh products will have to submit new applications to the FDA, demonstrating both the safety and effectiveness of these mesh devices.

While trial lawyers commend the FDA for taking this stronger position, the litigation that has been ongoing over the past six years has been the real driving force behind getting doctors to stop implanting these products and manufacturers to stop making them.  Juries have rendered substantial damages awards against manufacturers, such as Johnson & Johnson (J&J), Boston Scientific Corporation, and others, leading to large-scale settlements of thousands of these lawsuits.  For example, in 2014, Endo International, an Ireland-based company, settled approximately 20,000 lawsuits involving mesh products for $830 million.  In April of 2015, Boston Scientific Corporation settled approximately 3,000 cases for $119 million.  By the end of 2015, Boston Scientific had settled a total of approximately 6,000 cases.  Interestingly, J&J, who still has thousands of lawsuits pending against it, stopped selling transvaginal mesh products in 2012.  However, the company claimed that its decision to stop selling its products was not related to the pending lawsuits.  This has not insulated J&J from liability.  In December of 2015, after deliberating for less than 24 hours, a Philadelphia jury awarded a woman implanted with a J&J Prolift pelvic mesh product $5.5 million in compensatory damages and $7 million in punitive damages, resulting in a total jury award of $12.5 million.

The pelvic mesh litigation is another example of the civil justice system being able to bring about changes that benefit the public.  While the FDA was taking years to classify and reclassify the risks associated with pelvic mesh products, trial lawyers have produced evidence of the products’ danger and obtained jury verdicts to prove the point.  The defective medical product attorneys at Suthers Law Firm are proud to have represented numerous women in successful cases against the manufacturers of these unsafe and ineffective products.