Thousands of women currently suffer from complications that occurred after they underwent transvaginal mesh placement for treatment of pelvic organ prolapse (POP). For the latest Transvaginal mesh lawsuit 2012 please contact us for a free consultation. POP is a condition in which one or more pelvic organs fall from their normal positions, and bulge into the vagina. Surgical mesh (also called the bladder sling) is installed vaginally – a less-invasive approach than traditional abdominal surgery – to hold the prolapsed organs in place. When the device fails, it causes serious side effects. Complications, such as vaginal drainage, pain during sex, and mesh erosion have resulted in hundreds of vaginal mesh lawsuit claims. These complications have also prompted at least one large vaginal mesh recall in 2012.
In July 2011, the FDA released a set of recommendations for patients considering vaginal mesh placement for POP repair, and health care providers responsible for performing the procedure. Those recommendations provide insight into the risk of serious mesh complications. We’ll describe a few of them below.
Non-Vaginal Mesh Treatments For POP
The FDA recommends that women discuss all POP treatment options with their physicians before undergoing transvaginal mesh placement. Moreover, if their doctors recommend vaginal mesh, women are encouraged to learn the reasons.
This suggests the risks involved with vaginal placement of the bladder sling are high given the expected outcomes. Other treatment options, such as physical therapy and mesh placement via abdominal surgery, may offer more suitable approaches.
Regular Follow-Up After Transvaginal Mesh Placement
Women are also strongly encouraged to schedule ongoing follow-up appointments with their doctors after surgery. The implied reason is so their doctors can detect complications as soon as possible, and address them before they worsen.
The FDA notes several specific complications, including continual bleeding and discharge from the vagina, and pain in the pelvis and groin during sexual intercourse. Women are cautioned to seek surgical care if they observe these side effects.
The FDA’s Recommendations To Health Care Providers
Health care providers are advised to seek special training for mesh placement through the vagina. Organ and blood vessel perforation during the procedure are common due to the limited working space available. The FDA cautions surgeons to take particular note of the bowel and bladder since the risk of perforations to these organs is high.
Also telling, doctors are encouraged to explain to their patients that placement of surgical mesh is permanent, and complications that arise may not be resolvable. In fact, they are advised to inform patients that vaginal mesh side effects can significantly lower their quality of life. The woman’s vagina may become scarred or narrowed, and sexual intercourse might cause pain.
The FDA’s recommendations to doctors suggest that transvaginal placement of mesh for POP repair poses dangers that may warrant avoiding the procedure. The agency goes on to discourage physicians from installing mesh for POP repair by mentioning that non-mesh procedures are as successful while avoiding known complications.
Doctors are told to consider that mesh placement could expose the patient to subsequent surgeries to address complications. In addition, while removal of the device may become necessary to resolve pain and other side effects, it may not be possible. The patient may be forced to live the remainder of her life with the complications.
The FDA also encourages surgeons to place mesh through abdominal surgery rather than through the vagina. There is a lower rate of complications associated with the latter approach.
These recommendations – for patients and health care providers – are clearly made to improve the safety of women who choose transvaginal placement of mesh for POP repair. But they do not excuse vaginal mesh manufacturers that endangered patients by producing defective medical devices.
Many of the pelvis mesh lawsuit claims that have recently been filed charge that the manufacturers were negligent in several ways. They failed to test their devices properly to ensure their safety and efficacy; they failed to inform the public about the potential complications that might arise; and they produced mesh products that were flawed.
If you received a pelvic mesh implant and have suffered from complications, you may be eligible for compensation for your injuries. Contact a vaginal mesh lawsuit attorney to discuss your options and for the latest bladder sling recall 2012 updates.
Making A Difference
We believe that the manufacturers of transvaginal mesh products should be held accountable for any harm they are legally responsible for and people should be fairly compensated for damages caused by surgery mesh complications… find out more
Requesting a free legal consultation does not create an attorney-client relationship and you are not considered a client until a representation agreement has been signed and your case has been accepted.