Boston Transvaginal Mesh Lawyers
Transvaginal Mesh Lawsuits
Any medical procedure or device comes with the risk of complications; however, there is a difference between acceptable and unacceptable complications. Complications caused by a physician's failure to heed official warnings are unacceptable, as are complications caused by defective manufacture or design. At the Kiley Law Group, LLC, our dedicated transvaginal mesh attorneys are committed to recovering just and maximum compensation for clients who have been harmed by the negligent actions of a physician or medical device manufacturer. With Tom Kiley, the Million Dollar Man, at your side, you will get the compensation you deserve.
What is Transvaginal Surgical Mesh?
Transvaginal mesh refers to the method of implanting surgical mesh through an incision in the vagina. Surgical mesh is a medical device made of absorbable biologic or non-absorbable or non-absorbable synthetic material that is used to strengthen and/or repair weakened or damaged tissue. Transvaginal mesh is widely used in the repair of stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
Pelvic Organ Prolapse
POP is a condition that involves the dropping, or prolapsing, of a pelvic organ, such as the uterus or bladder, from its normal position, causing it to push against the vaginal wall. This usually occurs when the pelvic muscles are weak or stretched as a result of childbirth or surgery.
Stress Urinary Incontinence
SUI is also widely treated through the implantation of surgical mesh through the vagina. SUI, which is also referred to as “effort incontinence,” is the inability to prevent involuntary urination as the result of weak pelvic muscles.
FDA Warning of Serious Complications
October 2008
In a 2008 public health notification, the U.S. Food and Drug Administration (FDA) issued a warning on the serious complications associated with transvaginal placement of surgical mesh for the repair of SUI and POP. The FDA had received over 1,000 reports of vaginal mesh complications during the period between 2005 and 2007 from nine surgical mesh manufacturers. The reported complications included:
- Pain;
- Erosion through vaginal epithelium;
- Urinary problems;
- Infection; and
- Recurrence of incontinence or organ prolapse.
Treatments of these complications include:
- Drainage of hematomas or abscesses;
- Blood transfusions;
- IV therapy; and additional surgeries.
The FDA considered these complications “rare” and so no further action was taken.
July 2011
The FDA's official stance on the rarity of the aforementioned complications changed in 2011. On July 13, 2011, an official safety alert was issued warning patients and healthcare professionals that the serious complications arising from vaginal surgical mesh placement are “not rare.”
The FDA received an additional 2,874 reports, from January 1, 2008 through December 31, 2010, of complications caused by the transvaginal placement of surgical mesh used to repair POP and SUI. It was acknowledged that “mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.”
The FDA plans to move surgical mesh to its highest risk designation of Class III medical devices as well as conduct more clinical studies.
When to Contact a Boston Personal Injury Attorney
If you or a loved one has suffered from injury or illness as the result of a transvaginal surgical mesh repair of SUI or POP, you may be entitled to compensation. The experienced Boston vaginal mesh attorneys of the Kiley Law Group, LLC, will examine the details of your case and advise you on the best course of legal action. To learn more about your legal rights and getting the compensation you deserve, contact us today for a free legal consultation at (888) 208-1695. The call may be free, but the information, priceless.
