Jury verdict in the case of a Philadelphia woman injured after exercising for a promotional video for replacement knees. (Polett)
The government has issued a warning about the use of transvaginal surgical meshes to treat pelvic organ prolapse and urinary leakage, noting that thousands of women have reported serious complications including organ perforation, pain, bleeding, infection, and urinary incontinence.
In some cases the mesh -- also called a bladder sling, pelvic sling or pelvic support -- has eroded or shrunk after being inserted, necessitating additional surgeries. As a result, tens of thousands of lawsuits have been filed against the manufacturers of the urogynecological mesh products, including Ethicon Inc., a New Jersey subsidiary of Johnson & Johnson.
The CBS show 60 Minutes reported recently that more than 100,000 lawsuits have been filed in all, including some 48,000 against another vaginal mesh manufacturer, Boston Scientific. Its report claimed that some of the Boston Scientific devices may have been made using inferior mesh “smuggled” into the United States from China.
If you or a loved one suffered a severe or catastrophic injury as a result of a transvaginal mesh procedure, you should contact a transvaginal mesh attorney for a free evaluation of your case.
Kline & Specter, PC, with more than 40 attorneys, several of whom are also highly experienced doctors, including two OB/GYNs, is representing thousands of women from across the United States in their claims against the manufacturers of transvaginal mesh products. The law firm has the expertise to litigate transvaginal surgical mesh injury lawsuits.
Lee Balefsky, head of Kline & Specter's Mass Tort Department, is a member of the Plaintiffs' Steering Committee involved in all transvaginal mesh lawsuits nationwide. The firm, led by Balefsky, is playing an important role in the litigation nationally by taking depositions of the manufacturers' key employees in the case.
The U.S. Food and Drug Administration (FDA) in July 2011 issued its second notification in three years to doctors and patients warning about the problems with surgical mesh products. It said that “serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) are not rare” (FDA emphasis).
And that the problem was increasing dramatically: The agency received more than 1,000 reports of adverse events involving the mesh to treat POP and stress urinary incontinence (SUI) from 2005 – 2007 but almost triple that number in the following three years.
This has occurred as the urogynecologic surgical procedure using the mesh has also become increasingly popular. Doctors performed more than 100,000 of the operations in 2010, with about 75 percent performed transvaginally.
Unlike prescription drugs, which must be proven safe and effective before being sold, most medical devices face no such requirement.
Pelvic organ prolapse affects many women as they age, with the FDA estimating 30 to 50 percent of all women may experience POP during their lifetimes, with 2 percent developing symptoms such as urinary leaking during physical activity. POP occurs when the tissue holding the uterus, bladder, bowel and rectum become stretched or weak and the organs fall down or slip out of place. The mesh is used as a sort of cradle or nest to hold up a patient’s insides.
But over time, erosion or contraction of the mesh – described as being made of a material similar to that of Rubbermaid storage containers -- has led to complications, with symptoms including bleeding, severe pelvic pain, painful sexual intercourse and urinary problems.
If you think you may have a claim, please call our transvaginal mesh attorneys at 800-243-1100.
Attorney Slams Pelvic Mesh Maker As 'Beyond Reckless' in Closing, The Legal Intelligencer, 2/10/16
Jury Awards $13.5M in Second Pelvic Mesh Trial, The Legal Intellgencer, 2/10/16
Jury Ready To Decide 2nd Philly Pelvic Mesh Case, Law360, 2/9/16
Bard Mesh Patients Cite Slow MDL Pace In Bid To Move Suits, Law360, 2/3/16
Pelvic Mesh Counsel Sanctioned for ‘Poisoning’ Questions, The Legal Intelligencer, 2/3/16
Parties spar over pelvic mesh efficacy in second trial, The Legal Intelligencer, 1/25/16
2nd J&J Pelvic Mesh Trial Kicks Off In Philly, Law360, 1/25/16
Phila. Judge Increases $12.5M Award In Pelvic Mesh Suit for Delay Damage, The Legal Intelligencer, 1/15/16
- J&J takes $12.5M hit in Philly transvaginal mesh trial, Drugwatch, 1/14/16
MDL Judge Urged To Move Ethicon, Bard Mesh Suits To Philly, Law360, 6/19/16
- Phila. court has jurisdiction in mesh cases, judge rules, The Legal Intelligencer, 4/6/15
- Phila. jury awards $12.5M in vaginal mesh case, The Philadelphia Inquirer, 12/24/15
- J&J Tagged With $7M Punitives In Pa. Pelvic Mesh Case, Law360, 12/22/15
First Phila. pelvic-mesh trial goes to jury, The Philadelphia Inquirer, 12/21/15
- Tom Kline comments on Pelvic Mesh Cases Expanding Into Latest Mass Tort, The Legal Intelligencer, 2/25/14
- Kline & Specter files suit in Pennsylvania for an Indiana women who sustained injuries after surgical implant of transvaginal mesh, The Pennsylvania Record, 6/6/13
- J&J to Stop Selling Surgical Mesh, The Wall Street Journal, 6/5/12