The FDA recently warned about the potential complications arising from surgeries like cystocele mesh repair. They stated that complications with the surgery are not rare, and warned physicians to be aware of the risks.
What is cystocele mesh repair, and why have so many women filed a lawsuit due to complications?
What is Cystocele Mesh Repair?
Cystocele is the name of a disorder in women in which the muscles and tissues between the bladder and the vagina stretch and weaken, causing the bladder to drop or prolapse into the vagina. Cystocele is often called “fallen bladder.” Other names include cystocele prolapse and cystocele bladder prolapse.
Childbirth, heavy lifting, and surgeries can all contribute to cystocele, as they may stretch and weaken the muscles. Menopause, as well, since it results in a drop of estrogen, can weaken muscles around the vagina, as they rely on estrogen for strength.
Once the bladder has dropped from its normal position, it can cause symptoms like urine leakage, incomplete emptying of the bladder, and stress urinary incontinence (SUI—urine leakage that occurs when a woman coughs, sneezes, or laughs). The severity of the symptoms depends on the severity of the cystocele:
- Grade 1 (mild): the bladder drops only a short way into the vagina
- Grade 2 (moderate): the bladder reaches the opening of the vagina
- Grade 3(severe): the bladder bulges through the opening of the vagina
Treatment for Cystocele Prolapse
Treatment for cystocele depends on the severity of the condition. Women with mild cystocele may be able to manage it simply by avoiding heavy lifting and straining. If symptoms are moderately bothersome, a doctor may recommend a pessary, which is a removable device placed in the vagina to help keep the bladder in place. Estrogen therapy may also help strengthen the muscles around the bladder.
For severe cases of cystocele, surgery may be required to move the bladder back into a normal position and keep it there. Traditional surgeries simply stitched the muscles and connective tissues together to hold the bladder, but this surgery was prone to relapse. Cystocele mesh repair seemed like a better option, until women started experiencing serious complications.
Cystocele Mesh Repair May Cause Complications
In cystocele mesh repair, a surgeon uses a synthetic surgical netting to help support and secure the bladder back in place, and to lend strength to surrounding muscles and tissues. Studies have shown that this repair typically lasts longer, as far as keeping the bladder in place, but unfortunately, it can cause more complications, which may include:
- Pelvic pain
- Mesh extrusion
- Painful intercourse
- Cystocele bladder prolapse recurrence
- Vaginal scarring and mesh erosion
FDA Warning About Cystocele Mesh Repair
In addition to the July 2011 FDA warning about the risks of complications with vaginal mesh repair, the agency also scheduled a subcommittee meeting to further evaluate the safety issues. The consensus from that meeting was that the safety of vaginal mesh is not well established, and more clinical studies need to be done on the currently available products.
A Cystocele Mesh Repair Lawyer May be Able to Help
If you or a loved one has experienced an injury as a result of a cystocele mesh repair, you may be eligible for compensation in a cystocele mesh repair lawsuit. Contact Chaffin Luhana LLP today for a confidential case evaluation at 1-888-480-1123.