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Ethicon 6/25
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Hundreds Of Women Call For End To TVT Surgery
Jun 24, 2015 | Sky News
By Charlotte Lomas,
Hundreds of women across the UK are calling for the ban of a medical procedure which has left them in chronic pain - with some unable to walk. -
Medtronic’s Covidien to put pelvic mesh cases to bed
Jun 24, 2015 | Mass Device
Medtronic‘s (NYSE:MDT) Covidien unit has agreed to settle some of the more than 11,000 claims involving its transvaginal mesh devices, which patients allege caused severe and painful side effects, according to a court filing. -
The Role of Bacterial Biofilms in Pelvic Mesh Slings for Incontinence
Jun 25, 2015 | Mesh Medical Device News Desk
By Jane Akre
According to ongoing research, bacterial biofilms are being studied for their role in inciting an autoimmune response in patients implanted with transvaginal mesh used to treat incontinence.
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Hundreds Of Women Call For End To TVT Surgery
Jun 24, 2015 | Sky News
By Charlotte Lomas,
Hundreds of women across the UK are calling for the ban of a medical procedure which has left them in chronic pain - with some unable to walk.
A campaign is highlighting the risks associated with TVT surgery, which is designed to help women who suffer with stress incontinence, mainly after childbirth.
Kath Sansom chose to have the operation, which involves implanting a synthetic mesh tape to support the bladder. However, the mother-of-two now wishes she had not tried to resolve the problem.
She explained: "I was a fitness junkie and loved boxing, high board diving and swimming.
"When I heard that a routine, low-risk operation could help improve my quality of life and stop my mild incontinence, I was excited.
"But it was the worst decision of my life. Ever since I have experienced severe pain.
"One day it will be in my legs and groin area. Another day it will be like cheese wire cutting into my tissues. And sometimes, it sends a shooting pain up my neck and across my shoulders."
Ms Sansom claims she can now only walk for 15 minutes before she gets dizzy and feels pain. She is taking nerve blocker medication to manage this, and says she was unaware of the risks of the surgery.
Despite her suffering, she says she feels lucky.
"Some women are in wheelchairs, some have to use sticks to walk and some women are suicidal," she added.
"They have lost their job, their marriage and are desperate."
She has launched a campaign calling for TVT surgery to be suspended, and for a national register to be set up to record the number of women whose surgery causes problems.
The same operation is under review in Scotland.
The body responsible for ensuring medical devices are safe in the UK is the Medicines and Healthcare Products Regulatory Agency (MHRA).
They said in a statement: "We have listened to and understand the concerns many women have.
"For the majority, the use of vaginal mesh implants is safe and effective. Our findings show that the benefits continue to outweigh the risks."
Approximately 13,000 women undergo TVT mesh surgery every year in England, and it's unclear how many experience problems.
In 2010, the official number that were removed was 603, yet many women say they are unaware of where to report their complaint.
Dr Alak Pal, a consultant obstetrician and gynaecologist in north-west London, says the TVT operation can be very beneficial, but only to the right patients.
He added: "The process of selecting surgery as an option needs to be thorough, and the patient needs to be aware of the risks involved."
Ms Sansom is booked in to have her mesh implant removed in September - an operation which carries great risk because the mesh is designed to be permanent.
Only two consultants are qualified to remove the mesh in England. Dr Sohier Elneil, a consultant in urogynaecology, is one of them - and is seeing more and more patients.
She said: "I used to see one or two a month who wanted the mesh taken out, and now it's more like five a week. My waiting list is full until October.
"Obviously, for some patients, this surgery is of benefit - but for some women I see it is a personal tragedy.
"The perception is that the amount of women who have had problems is minimal, but for every woman affected that is one too many."
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Medtronic’s Covidien to put pelvic mesh cases to bed
Jun 24, 2015 | Mass Device
Medtronic‘s (NYSE:MDT) Covidien unit has agreed to settle some of the more than 11,000 claims involving its transvaginal mesh devices, which patients allege caused severe and painful side effects, according to a court filing.
The filing on Tuesday in West Virginia federal court did not disclose the amount of the settlement nor how many cases would be resolved under the confidential agreement with one of the plaintiffs’ law firms leading the litigation, Blasingame Burch Garrard & Ashley.
Covidien recorded a pre-tax charge of about $180 million for the third quarter of 2014 related to litigation over mesh products. Also last year, Medtronic announced it was acquiring Covidien for $42.9 billion in cash and stock.
As of June 1, Covidien mesh products were involved in approximately 11,300 filed and unfiled claims, according to a regulatory filing on Tuesday with the U.S. Securities and Exchange Commission from Medtronic.
Two Covidien subsidiaries supplied mesh products to another medical-device manufacturer, and Covidien is indemnifying that company in some cases, according to the filing. Covidien also said it believed that company was responsible for indemnifying it for claims over the devices’ promotion and marketing.
While the filing did not name the manufacturer, C.R. Bard has disclosed in regulatory filings that two Covidien units supplied it with mesh products, and that Bard believed Covidien was responsible for defending or indemnifying it in approximately half of the more than 14,000 claims it faces.
Covidien, C.R. Bard and a lawyer for the settling plaintiffs did not immediately return requests for comment on Wednesday.
An estimated 100,000 lawsuits have been filed in U.S. state and federal courts against companies that make transvaginal mesh devices, alleging that poor design and substandard materials can cause side effects such as bleeding, infection and nerve damage.
Last year, Endo’s American Medical Systems was the first major manufacturer to resolve mesh litigation against it, saying it had set aside $1.6 billion to settle about 40,000 filed and unfiled claims.
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The Role of Bacterial Biofilms in Pelvic Mesh Slings for Incontinence
Jun 25, 2015 | Mesh Medical Device News Desk
By Jane Akre
According to ongoing research, bacterial biofilms are being studied for their role in inciting an autoimmune response in patients implanted with transvaginal mesh used to treat incontinence.
It’s long been noted that a mesh implant can cause pain, infection, organ perforation, nerve entrapment and vaginal scarring. Systemic symptoms have been noted as well and include muscle pain, arthritis, sinusitis, asthma, chronic fatigue, cognitive impairment and skin conditions.
As part of the latest ongoing research being conducted at UCLA, mesh explant segments showed chronic inflammation surrounded by bacterial colonies which was not found in patients who only suffered from mesh obstruction. That research is not yet published. Mesh News Desk will report on the findings when they become available.
One theory is that a transvaginal placement (through the vagina) of pelvic mesh leads to unavoidable contamination that may result in bacterial biofilms on the mesh in susceptible individuals. Biofilms provide a protective mechanism and can protect the bacterial colony from antibiotics. Over time, its subclinical infection may override the body’s immune system leading to long-term reaction to the mesh implant.
Biofilm formation is common on most polymeric materials and it thrives in high humidity.
Research conducted at U.C. Berkeley two years ago, used a super-resolution light microscopy to see the bacterial colonies and their protective biofilm coating. See the story here.
Using a new medical implant material and avoiding the transvaginal approach may minimize the risk of systemic symptoms. Unfortunately, the bulk of the 100,000 defective product lawsuits filed against seven mesh manufacturers resulted from the use of the transvaginal approach to implant a petroleum-based mesh product.Biomaterials Access Assurance Act and Immunity for Suppliers
The Biomaterials Access Assurance Act of 1998 (BAAA) provides protections for biomaterial suppliers of implanted medical devices from product liability litigation filed in civil suits. Ironically, petroleum-based products are referred to as biomaterials and they include Dacron, Polytetrafluorethylene (Teflon) and Polypropylene.
Common law protected biomaterials suppliers (Phillips Sumika, for example) from product liability lawsuits prior to BAAA but in 1998, Congress determined the industry warranted special protections because of the potential of the multi-billion dollar market.
There is an effort underway to repeal the Biomaterials Access Assurance Act of 1998. It would hold any supplier of raw material such as liable if they knowingly supply said materials to a medical device company to manufacture an implantable medical device, unless it is necessary to save lives. See theMesh News Desk story here.
The biomaterials market reportedly flourished after the BAAA and was predicted to be $58 billion in 2014.
But don’t look to the material supplier to assure its polymers are safe to be used in the human body.
From McDermott Law: “By performing additional testing on the product, however, biomaterials suppliers may paradoxically find themselves assuming greater legal risk, since a court could find a duty on the suppliers’ part to perform additional testing, provide more extensive disclosure or even withdraw products to avoid liability for the negligent performance of an undertaking.”
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