Surgical Treatment for Pelvic Organ Prolapse

vaginal mesh lawsuitPelvic organ prolapse refers to descent (or prolapse) of the vaginal walls and/or uterus below their normal positions. The bladder, rectal, and uterine tissue may project outward the vagina. There is a high risk pelvic organ prolapse for women who had multiple vaginal birth after menopause. The risk factors associated with POP are pelvic floor, connective tissue disorder, and obesity.

The woman’s quality of life may be affected by POP but it does not cause death. The treatment recommended by the doctor to women with POP is usually the ones which do not involve surgery. However, if you are experiencing major discomfort or inconvenience, surgery is the only definitive way to relieve symptoms and improve your quality of life.

In the event when a patient feels that the benefits of having surgery outweigh the risk, surgery may be considered as a treatment option. It is estimated that one in 10 women will have had surgery for prolapse by the time they are 80 years old. Surgery is used to repair the tissue that supports the prolapsed organ or tissue around the vagina.

One of the main surgical treatments for pelvic organ prolapse involves improving support for the pelvic organs. The prolapsed organs are stitched back into place, as well as stitching the existing tissue to make it stronger, during surgical treatment.

There are two ways in which the pelvic organ can be repaired: through the vagina or through incisions. The general anesthesia may help patients to fall asleep while surgeon are performing the surgery. Women undergoing pelvic organ repair may not encounter difficulty having children in the future.

Transvaginal mesh is considered to be a common treatment for POP. Moreover, it was announced by the FDA that transvaginal mesh can do more harm than good. According to the FDA, implant, which is surgically inserted to treat POP, has caused about 3,000 report of complications. These complications have provoked patients to file for a vaginal mesh lawsuit.

References:

  • mayoclinic.org/pelvic-organ-prolapse/treatment.html
  • health.harvard.edu/fhg/updates/update0805c.shtml
  • nhs.uk/Conditions/Prolapse-of-the-uterus/Pages/Treatment.aspx
  • http://c.ymcdn.com/sites/www.iuga.org/resource/resmgr/brochures/eng_pop.pdf

Court Denies Bard’s Request to Exclude Internal Memos in Mesh Bellwether Trial

The fourth and final vaginal mesh bellwether trial against C.R. Bard that has been scheduled for January 10, 2014 would have to proceed with the six company memos included as evidence, which the defendant had earlier requested to be excluded in the hearing.

This developed after Judge Joseph Goodwin denied the motion of C.R. Bard to exclude six internal memos written by a key company official and which contained discussions on design and material options that could possibly be used to make future pelvic mesh devices.

In filing its motion to exclude the documents, C.R. Bard enumerated a number of arguments that included the reference of Rule 403 of the Federal Rules of Civil Procedure. According to Bard, these memos should be excluded because any probative value is substantially outweighed by the risk of unfair prejudice and jury confusion.

All the points raised by the defendant were addressed by Judge Goodwin in his decision. On the matter of the law cited by Bard, the judge stated that Bard did not provide sufficient information on the way in which the jury might become prejudiced base on the documents.

Read More: C.R. Bard’s Request to Exclude Memos From Vaginal Mesh Trial Denied

Another Vaginal Mesh Device Cleared Through FDA’s 510(k) Premarket Notification Process

Partly to blame for the vaginal mesh device fiasco, according to concerned sectors, is the Food and Drug Administration’s 510(k) premarket notification (PMN) process, which allows a medical device to be distributed without complying stringent requirements such as clinical trials. All that is required is to show that the new device is “substantially equivalent” to a product already existing in the market.

Now, another vaginal mesh device, the RetroArc Retropubic Sling System from American Medical Systems (AMS) has been made available to the market after getting clearance from the FDA using the 510(k) PMN process.

This would mean that, similar to other sling devices that have been subjects of thousands of lawsuits, this new product from AMS did not also undergo any clinical trials to test for possible complications.

Like the other vaginal mesh implants that have allegedly caused life-altering injuries to countless patients, the AMS RetroArc Retropubic Sling System also uses surgical mesh made from polypropylene materials. This is the same type of material that experts have identified as the main cause for the severe complications which have harmed and disabled thousands of women.

Read More: AMS Receives Pre-Market Approval From FDA For New Vaginal Mesh Device

Surgical Treatment for Pelvic Organ Prolapse

Sunday, March 2, 2014

Pelvic organ prolapse refers to descent (or prolapse) of the vaginal walls and/or uterus below their normal positions. The bladder, rectal, and uterine tissue may project outward the…

Court Denies Bard’s Request to Exclude Internal Memos in Mesh Bellwether Trial

Tuesday, January 14, 2014

The fourth and final vaginal mesh bellwether trial against C.R. Bard that has been scheduled for January 10, 2014 would have to proceed with the six company memos…

Another Vaginal Mesh Device Cleared Through FDA’s 510(k) Premarket Notification Process

Friday, December 13, 2013

Partly to blame for the vaginal mesh device fiasco, according to concerned sectors, is the Food and Drug Administration’s 510(k) premarket notification (PMN) process, which allows a medical…

Vital Documents in Vaginal Mesh Litigation Allegedly Destroyed by Ethicon

Wednesday, December 4, 2013

The latest development in the vaginal mesh litigation, according to online media sources, is the reported destruction or loss of crucial documents and evidences by Ethicon, Inc., a…