Mesh Medical Device News Desk, March 7, 2019 ~ The mesh manufacturer, C.R. Bard will no market it polypropylene (PP) mesh implants in the United Kingdom according to the government.
At one time it was a leading manufacturer of pelvic floor and incontinence mesh in the world.
The announcement was made Thursday (here) – All pelvic mesh made by C.R. Bard will be pulled from the United Kingdom, according to a medical device alert issued by the government.
The UK regulatory agency MHRA (Medicines and Healthcare products Regulatory Agency) said in a statement:
“Bard has taken the decision to stop production of these devices as part of its business strategy. They are stopping production rather than continuing to invest in clinical data to support additional EU requirements. Therefore, implanted devices don’t need to be removed.”
Polypropylene mesh is used to support the pelvic floor or the urethra to treat incontinence. Bard PP mesh has been the subject of more than 15,500 defective product lawsuits in the U.S. and thousands more around the globe.
At one time, Bard was facing the fourth largest number of product liability trials, behind Ethicon (Johnson & Johnson), Boston Scientific, and AMS. Altogether consolidated cases amounted to more than 104,000 U.S. lawsuits.
Bard removed its pelvic meshes from the U.S. market in June 2012 after being ordered by the FDA to undergo post-approval marketing studies for three years on mesh-implanted women. By removing the products, the FDA relieved the company of monitoring the health of women who had been implanted.
The head of an anti-mesh group in Britain, Kath Sansom, of Sling the Mesh, says most pelvic organ prolapse mesh (POP) made in the UK is made by Bard.
Sansom tells Mesh News Desk that the group is delighted that hospitals across Great Britain must clear its shelves of Bard urogynaecological [sic] mesh products.
“This is huge news for campaigners and means until further notice, no women’s pelvic mesh operations are allowed in this country.
“It is also tinged with sadness because this operation has destroyed hundreds of women’s lives. Every day we see women struggling to cope with excruciating pain, some suicidal, 7/10 have lost their sex lives and many report failing marriages. For those with children at home, it affects them terribly. Some children end up having to be caretakers.”
“The J&J alternative is a Prolene mesh that has to be cut to fit, unlike the Bard pexy prolapse mesh kits.”
She cites the Baroness Cumberlege, who led a UK-wide safety review in July 2018, with the move. Cumberlege insists conditions for safety need to be met before the use of pelvic mesh can be considered safe.
Those conditions include insisting that surgeries be conducted by surgeons who are appropriately trained and only if they do them regularly. The review also recommends the creation of a registry to track any complications.
Scotland suspended the use of mesh for stress incontinence in 2014. Mesh complications include erosion, chronic infection and pain, mesh shrinkage, and autoimmune issues, among other problems.
MORE ON BARD
C.R. Bard, located in Murray Hill, New Jersey, was purchased by Becton Dickson (BD) in April 2017 for $24 billion.
C.R. Bard faced its first bellwether case in Charleston, WV in August 2013 in the Cisson trial. MND was there, the story is here.
At one time from its Covington, Georgia plant Bard made:
Avaulta Plus™ BioSynthetic Support System for POP ( Pelvic organ prolapse)
Avaulta Solo™ Synthetic Support System for POP
Faslata® Allograft – human graft tissue
Pelvicol® Tissue for SUI (stress urinary incontinence)
PelviSoft® Biomesh for SUI
Pelvitex™ Polypropylene Mesh for SUI
In August 2015, Bard agreed to settle 3,000 pelvic mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
SLING THE MESH
The online group, Sling the Mesh was formed in June 2015 and now has more than 7,300 members. It is the largest single support group for mesh injured. U.S. campaigners tend to form individual groups on Facebook so it is difficult to get a handle in the U.S. on the actual number of mesh-injured.
Sansom says in a statement, “It is disappointing that the Government do not think women with Bard mesh implanted need to be recalled or have this product removed. We also question why Bard does not want to carry out additional clinical trials required under EU regulations.”
One member of Sling the Mesh said “Bard nearly killed me two years ago. I lost ¾ of my bowel and I’m still suffering.”
The MHRA stopped short of any condemnation of the products saying, “It’s important to note, there are no specific safety concerns associated with this recall and there is no need for people to have the device removed or have any extra follow-up checks.”
Government guidelines under NICE (National Institute for Health and Care Excellence) should be released next month. In December 2017 it recommended vaginal prolapse mesh surgery be banned.
The mesh community believes mesh to be used only as a very last resort when other non-mesh surgical options have been tried.
MP Owen Smith chairs the All Party Parliamentary Group into mesh. He led a debate in the House of Commons last month where he said that toasters and plugs get tougher checks than medical implants. Smith wants National Registries and tougher regulations for all medical implants.
The debates in Parliament can be seen here.
POP mesh was first used in the UK in 2002. Incontinence mesh (slings) use began in 1997, one year before the U.S.
With this announcement prolapse mesh kit use ends in Great Britain.
Incontinence mesh was suspended in the UK in July of last year pending a UK wide safety review led by Baroness Julia Cumberlege.
British Medical Journal Blog, July 2018, UK bans transvaginal mesh: here’s 5 reasons why
MND, July 10, 2018, Incontinence Mes Use Suspended in England Pending Govt. Review
Mesh News Desk on Bard lawsuits
MND, March 21, 2018, McGinnis v CR Bard – What we know from past TVM Trials
MND, Bard Opening Arguments in Federal Transvaginal Mesh case, July 9, 2013
MND, May 23, 2013, C.R. Bard Lawsuits: Rulings Reveal Company Secrets
MND, June 13, 2017, C.R. Bard’s Pelvic Mesh Removed from the Market
Materials Safety Data Sheet
Bard Exhibit #200-1 Marlex Mesh MSDS
MND, July 29, 2013, Bard Faces Plaintiff After Mistrial in First Federal Case Against Transvaginal Mesh