The FDA Has Issued a Pelvic Mesh Recall Becuase of Serious Complications Linked To Transvaginal Mesh.

In 2011, the FDA issued a public notice to doctors and transvaginal mesh patients after 2,875 injuries relating to pelvic mesh were reported between 2008 and 2010.

These reported complications include transvaginal mesh devices from NINE different manufacturers. Many complications have led to pelvic mesh removal or bladder sling removal. 

Pelvic mesh and bladder sling devices are implanted through surgery. According to the FDA, contributing factors to complications may include the patient’s health, pelvic mesh material, the size and shape of the pelvic mesh, surgical procedures and estrogen levels.

In 2011, the FDA also issued a recall of transvaginal mesh devices made be Boston Scientific. The Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE were recalled because they may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.

The most common side effect reported to the FDA is vaginal mesh erosion, a potentially serious and painful complication involving the mesh that can cause the skin to split and can lead to transvaginal mesh removal.  

Other side effects include infection, recurrence of pelvic organ prolapse or stress urinary incontinence, all of which are medical problems pelvic mesh implants are intended to fix.

The potentially dangerous side effects became apparent in 2009 when a clinical trial was stopped prematurely after 15 percent of the women implanted with the pelvic mesh suffered vaginal mesh erosion within a period of only three months.

If you or a loved one may have been affected by transvaginal mesh side effects, please fill out the form on the right to receive a free initial consultation from a transvaginal mesh lawyer.

If you had a transvaginal mesh implant and suffered from serious side effects, you are not alone. 

If You Have Suffered Following A Pelvic Mesh Implant, You May Be Entitled To Compensation Through A Pelvic Mesh Lawsuit.