United Kingdom Archives - Carey Danis & Lowe

UK Women Call for Transvaginal Tape Surgery Ban

By | Product Liability, Transvaginal Mesh, Uncategorized

transvaginal_mesh_mdl_2013_settlements_side_effects_court_filing_lawsuitsHundreds of women in the United Kingdom are demanding that Transvaginal Tape (TVT) operations be suspended.

These women have been devastated by a variety of disorders from chronic pain to the inability to walk, resulting from the procedure to stop stress incontinence. They weren’t made aware of the potential life changing risks from the surgery.

Kath Sansom had the operation, involving the implant of an artificial mesh tape to support the bladder. Now the mother-of-two wishes she had never attempted to fix the minor problem.

Ms. Ransom was a self-described fitness junkie, participating in boxing, swimming and high diving before the surgery. Now she’s lucky if she can walk for 15 minutes before she gets dizzy and develops intense pain.

She launched the Sling the Mesh campaign, calling for TVT surgery to be suspended and for the government to create stricter policies for approving medical devices. She got the campaign idea from a neighboring country: Scotland placed a ban on the surgery in 2014.

In England approximately 13,000 women have TVT surgery every year. Officially, in 2010, 603 TVT surgeries were reversed. However only 15 adverse incident reports were made to the Medicines and Healthcare Products Regulatory Agency (MHRA).

Many women don’t know where to report their grievances. Kath Sansom intends to change that by calling attention to the problem with her campaign.

Carey Danis & Lowe Attorneys Can Help

The St. Louis personal injury attorneys at Carey Danis & Lowe are experts on transvaginal tape cases and are providing free legal evaluations. If you or someone you know has been harmed by transvaginal mesh products, please tell us about your case.

If you have questions about transvaginal mesh and the accompanying health complications, ask questions of our on-staff medical experts. Our team is here to support you with professional legal and medical advice.

Biomedical Engineer Delivers Testimony in California DePuy ASR Hip Trial: Hip Implant Designed with Life-Threatening Defects

By | Defective Medical Device litigation, Hip/Knee Replacement, Uncategorized

Biomedical Engineer Delivers Testimony in California DePuy ASR Hip Trial: Hip Implant Designed with Life-Threatening DefectsTestimony in the DePuy ASR Hip trial in California continues to shed light on the defective quality of Johnson & Johnson’s DePuy ASR Hip Replacement system. A biomedical engineer and McGill University professor served as an expert witness for the plaintiff, Loren Kransky, in the first DePuy ASR Hip lawsuit to go to trial. Kransky v. DePuy is being heard in a California Superior Court in Los Angeles County.

According to a Bloomberg News report, the biomedical engineer, Dennis Bobyn, stated that he believed the DePuy ASR Hip Replacement system was designed by Johnson & Johnson with several design flaws that caused an abnormally high rate of failure.

One of these DePuy ASR Hip implant defects involves the metal components, specifically the metal cup and the metal ball, that slide against one another causing a release of metal debris, which then enters the bloodstream and damages local tissues, bones, and muscles.

Metallosis, or metal poisoning, is a major health complication associated with the implantation of the DePuy ASR Hip Replacement system.

In their defense, lawyers for Johnson & Johnson are attempting to build an argument that Kransky’s health complications are unrelated to any defects with Kransky’s DePuy ASR Hip Replacement.

As detailed in a Bloomberg News report dating from February 8, the DePuy ASR Hip Replacement system has a recorded rate of failure in the United Kingdom of 12 percent in five years. An even high failure rate has been recorded in Australia at 40 percent.

In light of the DePuy ASR Hip implant’s abnormally high failure rates, Johnson & Johnson’s defense appears to be flimsy and inadequate.

The defective medical device lawyers at Carey Danis & Lowe are keeping a watchful eye on the court proceedings of Kransky v. DePuy. Furthermore, Carey Danis & Lowe is currently providing free legal consultations regarding DePuy ASR Hip cases. Contact Carey Danis & Lowe for a free legal evaluation and to file a DePuy ASR Hip Replacement lawsuit by calling 800.721.2519. 

UK Health Organizations Conduct Study on Transvaginal Mesh Safety

By | Defective Medical Device litigation, Transvaginal Mesh, Uncategorized

UK Health Organizations Conduct Study on Transvaginal Mesh SafetyIn the United Kingdom, the Department of Health and the Medicines and Healthcare Products Regulatory Agency (MHRA) have been collaborating on a safety review of transvaginal mesh. Their collaborative effort results from an observed need to analyze the safety of these medical devices and to provide UK surgeons, gynecologists, and urologists with the most current and pertinent information regarding transvaginal mesh and transvaginal tape.

One recommendation made by the reviewing body was to create a registry of patients who have received surgical implantation of either transvaginal mesh or transvaginal tape. The UK health officials hope to develop such a registry in order to make the data available to surgeons for review of post-surgery patient health.

In conducting its own analysis of reports and data relating to the safety of transvaginal mesh and transvaginal tape, the U.S. Food and Drug Administration discovered that severe health complications related to the surgical implantation of these vaginal medical devices are not rare. Furthermore, in its scientific literature review, the FDA made the conclusion that there was no significant benefit in using transvaginal mesh versus a non-mesh device in treating patients with pelvic organ prolapse (POP).

Also, the FDA noted that the most commonly reported transvaginal mesh health complication is vaginal mesh erosion.

Transvaginal mesh and transvaginal tape are used to treat women suffering from stress urinary incontinence (SUI) or pelvic organ prolapse (POP). Patients have reported to the MHRA in the UK and the FDA in the U.S. a number of severe health complications resulting from surgical implantation of transvaginal mesh. These serious health complications include vaginal bleeding, vaginal pain, painful intercourse, infection, scarring, transvaginal mesh erosion, and damage to surrounding tissues and organs.

Furthermore, some women must undergo revision or corrective surgeries following the initial implantation of their transvaginal mesh or transvaginal tape.

In the United States, transvaginal mesh and transvaginal tape manufacturers have pulled their defective medical devices off the market. Johnson & Johnson has removed four of its transvaginal mesh and transvaginal tape products from the market following increased reports of severe health complications related to these products. The Johnson & Johnson vaginal mesh recall included the Gynecare TVT Secur system, the Gynecare Prosima, the Gynecare Prolift and the Gynecare Prolift+M.

If you or a loved one has suffered from a transvaginal mesh or transvaginal tape implant, do not suffer in silence, and learn more about filing a defective surgical mesh claim. To file a transvaginal mesh lawsuit, contact an experienced defective medical device lawyer at Carey Danis & Lowe.