Background and history of the transvaginal mesh implant devices
Pelvic organ prolapse happens when the supportive tissue between the organs deteriorates or weakens. This is most frequent after childbirth, although there are other reasons. Gynecologists began using surgical mesh in the 1970s to repair vaginal tissue to treat pelvic organ prolapse.
Surgeons began to employ surgical mesh for pelvic organ prolapse repair, which was originally implanted to function as a supporting system for abdominal hernias to treat stress urinary incontinence, in the early 1990s. Transvaginal mesh was designed to prevent this problem. SUI develops after pregnancy and might result in urine leakage.
As a result, doctors and surgeons employed transvaginal mesh to prevent or treat this problem. The gadget was advertised as a solution to halt and prevent the unsightly problems associated with SUI.
As a result, hundreds of thousands of women signed up for or chose to have transvaginal mesh surgery. It is estimated that over 250,000 women choose to have this surgery performed each year.
Taking advantage of the product’s demand, the producers sold and advertised the product through the 510(k) approval procedure. Certain medical items can be sold or promoted without FDA clearance under the 510(k) procedure.
What are transvaginal mesh implants?
Transvaginal mesh is a device used to strengthen weakened vaginal walls in patients suffering from Pelvic Organ Prolapse (Pelvic Floor Collapse) and Stress Urinary Incontinence. The material used to make the product is polyester or polypropylene. The product is placed in the female pelvic organs through minimally invasive surgery to strengthen the vaginal wall and repair pelvic floor disorders.
How did the surgical mesh devices go from a marvel to a global medical menace?
2008-2011- The Food and Drug Administration (FDA) issues its first warning
The FDA issued a Public Health Notification and Additional Patient Information in 2008 on significant risks related to surgical mesh used to treat SUI and POP.
In 2011, a subsequent safety advisory was made on pelvic mesh, especially for POP. The FDA determined that mesh complications were not uncommon with these procedures and that synthetic mesh surgeries did not relieve patients’ complaints any better than non-mesh treatments.
2012 – 2013 – The first surgical mesh lawsuits go to trial
C.R. Bard (Bard) voluntarily recalled its Avaulta Plus vaginal mesh in July 2012, only weeks before losing a $3.6 million judgment to a woman with serious complications with the vaginal mesh implants.
In February 2013, Johnson & Johnson (J&J) lost the first federal mesh litigation, with American Medical Systems (AMS) becoming the first firm to reach a substantial settlement in July 2013. Later the same month, Bard lost the second federal transvaginal mesh case.
January 2016 – The vaginal mesh implants are reclassified.
The FDA changed urogynaecological surgical mesh from class II to class III, requiring the devices to be submitted with a 501(k).
All manufacturers discontinued selling surgical mesh intended to treat pelvic floor disorders due to the FDA’s actions.
2017 – The case against J&J in Australia and the ban on mesh devices
In federal court, a trial against J&J involving 700 Australian patients began. The business was accused of not testing the mesh devices and downplaying their risks to both surgeons and patients.
The pharmaceutical firm was accused of portraying the devices as simple to implant, even though transvaginal mesh procedures are very sophisticated and should only be performed by qualified and experienced surgeons.
In November 2017, The Therapeutic Goods Administration of Australia determined that the risks to patients of employing mesh to treat POP exceeded the benefits and discreetly prohibited using the devices for prolapse surgery.
December 2017 – New Zealand bans all surgical mesh procedures
The Ministry of Health in New Zealand followed suit and prohibited using transvaginal mesh kits. It remains the only country that does so for both POP and SUI.
2017 December – media and research controversy in Britain
According to research published in the British Medical Journal, 61 manufacturers supplied mesh implants without clinical studies, with inadequate evidence of safety and effectiveness.
In the same month, BBC found that Ethicon failed to fully notify UK clinicians about the hazards of transvaginal mesh and had not thoroughly tested their kits before selling them.
According to the research, Ethicon’s TVT-Secur implant, which was removed from the market in 2012, was available for commercial purchase after only five weeks of testing on 31 women and sheep.
2018 – 2019 – The UK bans all mesh devices and then reinstates it
In July 2018, the UK Department of Health and NHS England acknowledged Baroness Cumberlege’s suggestions that surgical mesh products could not be declared safe unless specific requirements were satisfied.
The conditions were that doctors only undertake the procedures if they were adequately educated and did them regularly and that a register on the devices be created to track issues as they arise.
The British National Institute of Health and Care Excellence (Nice) decided in April 2019 that mesh implants might be given by the NHS in England again if Cumberlege’s criteria were followed. However, the NHS is not required to follow NICE’s recommendations, and the ‘hold’ on these procedures remains in place.
2019 – Transvaginal mesh to treat pelvic organ prolapse banned in the US
Manufacturers of surgical mesh devices for transvaginal prolapse repair were ordered to cease marketing and distributing their goods immediately.
As a result, there are presently no FDA-approved surgical mesh solutions for transvaginal POP repair that may be lawfully implanted in the United States.
What to do if you or a loved one has suffered from mesh-related complications
Those who have been harmed as a result of such implants are unquestionably entitled to compensation. The severity of the injuries might range from severe to moderate. However, the psychological damage and probable financial expense of a vaginal mesh injury lawsuit may justify pursuing one.
Some of the complications related to mesh implants include:
· Organ perforation
· Debilitating pain
· Weakened or damaged tissue
· Painful intercourse
· Vaginal scarring
· Vaginal shrinkage (as scar tissue builds)
· Mesh erosion
· Weakened vaginal wall
· Recurring stress incontinence
· Neuro-muscular issues
If you suspect your injuries are the consequence of a transvaginal mesh implant, you should take the following actions. First, consult with your doctor to seek a second perspective; they can typically establish the source of your issue.
Second, acquire any required files, including your medical records, interactions with your physician, and any other material you believe may be relevant.
Third, speak with a transvaginal mesh lawyer. It is critical to get legal counsel. Companies that manufacture and distribute these items will not directly settle with you. You should hire an attorney to manage your case and seek fair compensation for your injuries.