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Cystocele and Rectocele Mesh Repair, FDA Warnings

Risks with Cystocele and Rectocele Mesh Repair , FDA Warnings, Vaginal mesh lawyers

In July 2011, the FDA released a safety communication warning healthcare providers of the serious risks associated with surgical mesh used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Specifically, the FDA stated that complications were not rare, and that surgery with the mesh may be no better than traditional surgery options that don’t use mesh.

Public Citizen and Vaginal mesh

In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. They stressed that there is a need for these non-absorbable vaginal meshes to be removed from the market since it’s benefits over other non-mesh procedures used to repair POP and SUI were unseen, and patients who received them developed fatal reactions. The group also recommends that all non-absorbable vaginal mesh be tested appropriately for safety and effectiveness before the FDA approves its availability in the market.

FDA 510 (K) Process

Manufacturers needed only to show they were similar to devices already on the market to gain approval through the FDA’s 510(k) approval process. The remaining eight recalled devices didn’t have to go through any kind of FDA review. Of the 113 recalls, 35 were for cardiovascular devices, including automated external defibrillators, or AEDs, and only 12 of them had been required to undergo patient testing.

POP repair surgeries may include cystocele and rectocele. Unfortunately, complications have been found with both.
Types of POP Repair Include Cystocele and Rectocele.The sling procedure, or suburethral sling procedure, refers to a particular kind of surgery using ancillary material to aid in closure of the urethral sphincter function of the bladder. It is performed as a treatment of severe urinary incontinence. The sling procedure, also known as the suburethral fascial sling or the pubovaginal sling, has many forms due to advances in the types of material used for the sling. Some popular types of sling material are Teflon (polytetrafluoroethylene), Gore-Tex ® , and rectus fascia (fibrous tissue of the rectum).

Cystocele and rectocele repair

  • Cystocele—bladder prolapse
  • Rectocele—rectal prolapse (end of the large intestine, or rectum)
  • Uterine prolapse
  • Vaginal prolapse
  • Enterocele—herniated small bowel

Mesh was initially incorporated into POP surgical repair because it offered more support to the affected organ and helped shore up surrounding muscles and tissues. Since the risk for recurrence of prolapse is high in women who have cystocele surgery and rectocele surgery, the hope was that surgical mesh would help sustain the repair. The FDA received many reports, however, or cystocele mesh complications and rectocele mesh complications.

Mesh complications

  • erosion of mesh
  • serious infection
  • recurrence of pop / sui
  • perforation
  • pain
  • corrective surgeries
  • injury to other organs
  • vaginal scarring
  • urinary problems
  • hardening of mesh

Cystocele Mesh Complications and Rectocele Mesh Complications

During cystocele surgery, transvaginal mesh is inserted through the vagina to help act as a barrier and to hold the bladder in place. The mesh is also intended to help stop related problems like incontinence.

A rectocele occurs when the thin wall of tissue separating the rectum from the vagina weakens, allowing the front of the rectum to bulge into the vagina. During rectocele surgery, excess stretched tissue is removed through the vagina, and a mesh patch may be used to support and strengthen the wall. (Surgery may also proceed from the abdomen, anus, or perineum.)

Though surgical mesh does seem to provide better support for pelvic organs, cystocele mesh complications and rectocele mesh complications made the improvement a moot point. The FDA, in its 2011 warning, mentioned that it had received nearly 3,000 reports of vaginal mesh complications between 2008 and 2010, with the most common being mesh erosion through the vagina. Mesh erosion can require multiple surgeries to repair and may be extremely debilitating.

Other cystocele mesh complications and rectocele mesh complications included pain, infection, bleeding, pain during sex, organ perforation, urinary problems, recurrent prolapse, vaginal scarring/shrinkage, and neuro-muscular problems. Many required additional surgical treatment and hospitalization.
Cystocele Surgery and Rectocele Surgery

Cystocele, urethrocele, enterocele, and rectocele are particularly likely to occur together. Urethrocele is virtually always accompanied by cystocele (cystourethrocele). Cystocele and cystourethrocele commonly develop when the pubocervical vesical fascia is weakened. Enterocele usually occurs after a hysterectomy. Weakness in the pubocervical fascia and rectovaginal fascia allows the apex of the vagina, which contains the peritoneum and small bowel, to descend. Rectocele results from disruption of the levator ani muscles.

Severity of these disorders can be graded based on level of protrusion:

  • 1st degree: To the upper vagina
  • 2nd degree: To the introitus
  • 3rd degree: External to the introitus

If you have been injured due to a vaginal mesh from any of the manufactuirers listed below contact Vaginal mesh Helpline 1 877 522-2123

Manufacturers

Johnson & Johnson

  • Ethicon TVT
  • Gynecare Prolift
  • Gynecare Prosima
  • Gynecare TVT
  • Gynemesh PS

C.R. Bard

  • Avaulta PlusT BioSynthetic Support
  • Avaulta SoloT Synthetic Support
  • Faslata Allograft
  • PelvitexT Polypropylene Mesh
  • Pelvicol Tissue
  • PelviSoft Biomesh

Boston Scientific

  • AdvantageT Sling System
  • Prefyx Mid UT Mesh Sling System
  • Prefyx PPST System
  • Obtryx Curved Single
  • ObtryxMesh Sling
  • Arise
  • Pinnacle
  • Solyx
  • Lynx

American Medical Systems

  • SPARC
  • BioArc
  • MiniArc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • Perigree

vaginalmeshhelpline.com

Whistle blower and Qui Tam Lawyers

Whistleblower and Qui Tam Lawyers,False Claims Act

When an employer is suspected of engaging in illegal actions and benefiting from these actions, an employee may take it upon him or herself to report this to the proper authorities. When this happens, the individual who did the reporting is called a whistleblower. Lawyers of Free Legal Shield have experience helping employees with whistleblower representation for many years. We can protect the rights of employees who are acting as the whistleblower. Qui Tam and whistleblower cases can fall under the category of class action litigation.

Whistleblower

Many whistleblowers find themselves facing problems for the reporting of the suspected activities of their employer. Qui Tam and Whistleblower lawyers assist employees with whistleblower cases and the potential for retaliation or actions taken by the employer.

Qui Tam

Closely related to whistleblower actions, qui tam is a provision of the federal False Claims Act. Under this act, a qui tam action may be filed by a private citizen (usually the whistleblower) charging fraud against a government contractor or a business receiving government funds. The result of this lawsuit is that the citizen may share in the funds that are recovered by the government. Some Qui Tam cses can result in substantial compensation to the whistleblower. Protecting the public against fraud is the purchase of Qui Tam. It is a citizens responsibilty to protect all by reporting illegal theft of Government funds.

Qui Tam in the Health Care Industry

One area in which Qui Tam claims are growing is the health care industry. When an employee has knowledge of fraud involving Medicare, pharmaceutical misconduct or other activity involving government reimbursement or payment for health care, they should speak to a lawyer at our firm for assistance in determining if they may have uncovered a valid claim for wrongdoing and filing a qui tam lawsuit under the False Claims Act. If you report a government fraud or Qui Tam case you may be entitled to substantial compensation.

For more information about whistleblower and qui tam cases contact Free Legal Shield.