TO ALL PATIENTS CONSIDERING (OR WHO HAVE RECEIVED) A SURGICAL MESH IMPLANT
On July 13, 2011, the Food and Drug Administration (FDA) issued an official safety communication entitled “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication”.
This safety communication was addressed to healthcare providers who have implanted surgical mesh to repair pelvic organ prolapse and/or stress urinary incontinence or are involved in the care of these patients, as well as to:
“Patients who are considering or have received a surgical mesh implant to repair pelvic organ prolapse and/or stress urinary incontinence[.]”
Hopefully, if you are one such patient, you have been made aware of and reviewed this update, which is available at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm.
Based on new information gathered since 2008, the FDA has determined that, among other things:
a) SERIOUS COMPLICATIONS associated with surgical mesh for transvaginal repair of POP ARE NOT RARE;
b) transvaginal POP repair with mesh MAY EXPOSE PATIENTS TO GREATER RISK than traditional non-mesh repair; and
c) the most complications include mesh erosion (where the mesh erodes or protrudes through the vaginal wall or other barrier), and mesh shrinkage/contraction. (See link above).
According to the safety communication, patients suffering from complications of the transvaginal mesh implants complain of severe pain, severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse, vaginal shortening, vaginal tightening and vaginal pain. Also, men may experience irritation and pain to the penis during sexual intercourse with implant patients when the mesh is exposed in mesh erosion.
In certain situations, an implant patient may have the ability to sue the manufacturer for problems arising from the implant itself, and the physician who performed the implantation surgery, among others. Strict time limits do apply, and it is important to immediately consult with an attorney should you experience any of the above-mentioned concerns. You may contact our office at (951) 682-6400 for a free consultation.