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Posted On: May 10, 2013 by Altman & Altman

Russian Study Says Vaginal Mesh Implant Injury Risk is Higher for Younger Women, Hysterectomy Patients

According to a new study by Russian scientists, younger women with less serious cases of pelvic organ prolapse and those who had hysterectomies appear to be more at risk of experiencing post-surgical complications after they are implanted with a vaginal mesh device than other patients. The scientists presented their findings at the annual Congress of the European Association of Urology earlier this year.

At Altman & Altman, LLP our Boston vaginal mesh injury lawyers represent women who have suffered serious health complications from an implant device. You may have grounds for a Massachusetts transvaginal mesh lawsuit against one of these manufacturers—Avaulta, Bard, Tyco, Sofradim, Gynecare, American Medical Systems, Boston Scientific, Johnson & Johnson’s Ethicon, Mentor, Uretex, and others. Vaginal mesh devices are also used to treat stress urinary incontinence.

The study group was comprised of 677 patients who underwent vaginal implant mesh procedures between 2006 and 2010 as part of their treatment for POP. One month after their surgeries, the scientists conducted follow up evaluations, and then again three months later. They found that 17% of the participants experienced vaginal mesh complications:

• 2.2% suffered bleeding during surgery
• 5.5% developed vaginal and pelvic hematomas
• 1.6% sustained bladder injury during the procedure
• 5 patients developed rectal damage
• 1 patient suffered ureteral damage

Post-vaginal mesh surgery, complications included:

• 4.8% experienced mesh erosion
• 2.4% experienced painful intercourse
• 4 patients developed pelvic abscesses
• 7 patients experienced mesh shrinkage

The US Food and Drug Administration says vaginal mesh erosion is the most common complication related to this device when used for pelvic organ repair. Also referred to as surgical mesh protrusion, exposure, or extrusion, this problem involves the mesh device eroding through the vaginal wall, potentially causing infection, pain, bleeding, incontinence, painful sex, prolapse relapse, vaginal scarring, neuro-muscular issues, and vaginal shrinkage.

One possible cause of vaginal mesh erosion is that manufacturers may not have conducted the necessary clinical trials to test the safety of the mesh material for use in the pelvic area. The FDA says that 10% of these mesh devices may fail within a couple of years of implant. Some studies say their failure rate may be as high as 17%.

Already, the federal agency has issued more than one safety warning about transvaginal mesh, first announcing that adverse effects related to the implant device had been reported, then later notifying the public that transvaginal mesh complications are not a rare occurrence. In that warning, the FDA also noted that transvaginal mesh devices used to treat pelvic organ prolapse may present risks not associated with more traditional non-mesh surgeries.

Thousands of women have filed vaginal mesh lawsuits to recover compensation for the harm they have suffered. In addition to a Boston products liability claim against the manufacturer, you may also have grounds for a Massachusetts medical malpractice case if medical mistakes or negligence played a part in causing your complications.

Your case assessment with our Boston transvaginal mesh injury law firm is free. Contact us today.

Urogynecologic Surgical Mesh Implants, FDA

European Association of Urology


More Blog Posts:
Products Liability Claims in Pelvic Mesh Lawsuit Against Boston Scientific Corp. Can Proceed, Drug Injury Lawyers Blog, April 12, 2013

Woman Awarded $3.35 million in Vaginal Mesh Case against Johnson & Johnson, Boston Injury Lawyer Blog, April 11, 2013

Bard Avaulta Transvaginal Mesh Lawsuit to Go to Trial in New Jersey, Drug Injury Lawyers Blog, February 20, 2013