Bloomberg Report: Watchdog Group Calls FDA to Recall Synthetic Mesh
According to a recent Bloomberg article, the public interest group Public Citizen is demanding the FDA to immediately recall all synthetic mesh products, due to the dangers they present to patients. Women who received synthetic mesh products in surgeries treating pelvic organ prolapse may be at risk of serious and painful side effects, including erosion, organ perforation and urinary problems.
The Schmidt Firm, LLP is currently accepting synthetic mesh induced injury cases in all 50 states. If you or somebody you know has been injured by synthetic mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Synthetic Mesh: An Overview
August 25, 2011 — Public Citizen, a Washington based watchdrog group founded by Ralph Nader, released a statement demanding the immediate recall of synthetic mesh products used to treat pelvic organ prolapse (POP), which is caused when muscles and tissue around the pelvic organs (including the bladder, rectum and uterus) weaken, causing these organs to slip into the vagina.
Synthetic mesh insertion is one method used to correct the condition. It involves implanting synthetic mesh into the body to reinforce the failing tissue around the organs. Most often, the synthetic mesh is inserted transvaginally, or through the vaginal wall.
Synthetic mesh can also be used to support the urethra, in order to treat stress urinary incontinence (SUI).
In their statement, Public Citizen estimated that approximately 67,500 women had synthetic mesh implanted transvaginally last year. Of these, 1,503 reported complications to the FDA between January 2008 and December 2010.
As a result, the FDA issued a safety warning about their concerns on July 13. In the warning, the FDA stated that the serious complications related to synthetic mesh are not rare, as previously believed, and other forms of POP treatment may be more effective. In particular, they found that synthetic mesh repairs introduced risks not present in traditional non-mesh surgeries.
“Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately,” Michael Carome, deputy director of Public Citizen’s Health Research Group, said in a statement.
The major problem is non-absorbable synthetic material can erode, causing painful side effects, which include bleeding and recurrence of POP or urinary incontinence, which is characterized by the leakage of urine during moments of physical activity. Mesh erosion can require multiple surgeries to repair the problem.
Public Citizen is calling for the FDA to place stricter approval requirements on future synthetic mesh and to recall all currently made products, which are produced by at least 9 manufacturers, including Johnson & Johnson and Boston Scientific Corp.
On Oct. 20, 2008, the FDA issued a previous Public Health Notification concerning the serious complications associated with surgical mesh implanted transvaginally. During this time, the FDA received over 1,000 reports of complications from synthetic mesh implants.
Synthetic Mesh Side Effects
Symptoms associated with synthetic mesh complications include:
- Infection
- Bleeding
- Urinary incontinence (leakage of urine)
- Severe pelvic or vaginal pain
- Painful sexual intercourse
- Inability to engage in sexual intercourse
- Organ perforation
- Recurring prolapse
- Neuro-muscular problems
- Vaginal scarring
- Vaginal shrinking
Do I Have a Synthetic Mesh Lawsuit?
The Schmidt Firm, LLP is currently accepting synthetic mesh induced injury cases in all 50 states. If you or somebody you know has been injured by synthetic mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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