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Transvaginal Mesh Warnings to be Strengthened in Scotland at the Urging of Mesh-Injured

The Sunday Mail

The Sunday Mail

Scotland is making changes in the way the public is warned about transvaginal mesh.

The Scottish Parliament set up a transvaginal mesh working group in May 2013. Last week the TVM working group met with the Minister for Health and Well Being.

Scotland’s Health Minister Alex Neil has ordered the National Health Service to warn women about transvaginal mesh surgery after a series of reports in the Sunday Mail about the “horrific complications” suffered by hundreds of patients.

“Officials will produce revised consent forms and information leaflets within two weeks. The move follows our campaign revealing how women have been crippled and maimed by polypropylene mesh implanted during surgery meant to help bladder and prolapse problems.”

Mr. Neil made the announcement with five mesh victims and vowed that all health boards will be asked to use these new forms. A leaflet will be given to all women considering surgery with mesh. The Sunday Mail reports it has received contacts from more than 300 people who tell “how their lives were destroyed by the implants.”

Ironically there have been only six reports of complications by doctors in Scotland to United Kingdom’s version of the FDA, the Medicines and Healthcare Regulatory Agency.

Neil says “clearly the system isn’t working. Doctors aren’t compelled to report adverse incidents to the MHRA.”

Anti-mesh campaigners are calling for an implant register to record procedures involving implantable medical devices such as mesh, breast implants and hip replacements. The European Union was recently rocked by the PIP breast implant scandal where a French manufacturer was using industrial grade silicone to fill breast implants. The government has had to step in and pay for implant removal surgeries.

Dr. Shlomo  Raz UCLA

Dr. M. T. Margolis

Dr. M. T. Margolis

Drs. Raz, Margolis Help

Dr. Michael Thomas Margolis of Bay Area Pelvic Surgery and Dr. Shlomo Raz, a urologist from UCLA added their comments to the proceedings. Dr. Margolis wrote a letter to Minister Alex Neil and DR. Raz commented by email.   Here is the letter.

Dr. Margolis is a surgeon in the area of female pelvic reconstruction. He’s been removing mesh implants since the mid 1990’s and now removes two a week. He reports complications include injuries to the bladder, bowel, blood vessels and vagina.

He told the parliament he’s treated “patients with vaginal mesh erosion, chronic complications of mesh including chronic infection, chronic scarring, chronic pain, morbid disfigurement and loss of function of the vagina.”  Many marriages are ended by the mesh issue, he says.

Dr. Raz reported that partial mesh removals do not work for pain “It must be removed completely. Ultrasound is the only test that shows mesh. No other imaging will show it.”

“In the last 6 years we have removed more than 500 mesh complications. 70% of the patients are improved or cured while 30% are permanent disabled from the mesh including vaginal pain, leg pain, pain during intercourse. We remove all the mesh. This is the only hope for patients with complications from mesh,” Dr. Raz wrote in an email.

The working group in Scotland is making positive progress, say advocates, as are colleagues in England that recently met with Lord Howe at Westminster in London. #

Learn More:

United Kingdom (UK) News Release,   September 27, 2013

http://www.theparliament.com/latest-news/article/newsarticle/meps-vote-for-tougher-controls-on-medical-devices/#.UkgJb4akoZ6

Facebook Scottish Mesh Survivors

https://www.facebook.com/karen.neil.16503

 

5 Comments

  1. Nonie Wideman says:

    awesome hard work ! job well done Scottish friends….that is quite an accomplishment ! now if the rest of our countries would open their eyes and minds to the disaster and be pro-active in warning, recalling and or reclassifying mesh plus creating a registry to track all permanent implant devices the medical world would be a safer place for us to visit…. thank you for all of your hard work …be blessed!

  2. Bravo Scotland! Valuing harmed patients and validating their stories by direct corrective action will save lives and the healthcare budget of your nation. In the U.S. the overly entitled medical device cartel is now holding our country hostage in a budget funding shut down to force changes in the Affordable Care Act to eliminate the paltry 2.3% tax. The U.S. FDA was the gold standard of regulation until it was infiltrated by industry influences, defunded to a level of irrelevance and ignored by legislators that could have progressively adapted laws to reflect the advancement of profiteering by this industry and updating the FDA/CDRH charter.

  3. top_bard@hotmail.com says:

    Awesome reporting by Marion Scott of The Scottish Sunday Mail, raising awareness at every opportunity is key to tell the true heartache polypropylene mesh medical devices are causing and have caused unsuspecting patients. Thanks Jane for another fantastic article. There are a lot more doctors out there that have the same beliefs as Doctor Margolis and Doctor Raz, they just need to come out from under their theatre masks and let their voices be heard. Thanks to Doctor Raz and Doctor Margolis who’s letter was awesome and he has made the comment “we will prevail but it will be a hard fight” From the wider working group patients in Scotland, “we won’t stop fighting that good fight”

  4. Ann B says:

    Well done to all the ladies of the Scottish Working Group Party. I know you have worked really hard and you are now reaping the benefits. I would also like to thank certain members(you know who you are) in helping me achieve what I think was a sucessfull meeting at Westminster. I could not have done it without your input. A big thank you also goes to Marion Scott of the Sunday Mail for believing in the girls and being with them every step of the way.

  5. Jane Akre says:

    You all may be interested in the Scottish legal standard for medical malpractice.

    It’s called Hunter v. Hanley and it is the Liability Legal test in Scotland.

    It is a very high bar. It says the duty of a doctor is to take ‘reasonable care” in day to day activities and that is owed to everyone. For a doctor it must be a mistake that no competent doctor would make. A mere mistake would not make a doctor liable. A failure to meet best practice is not enough. It must be more akin to a “blunder.” A blunder would require someone to be completely incompetent.

    In England the Bolam Test applies to doctors and residents. “The Defence” requires a letter from two doctors saying the course of action was proper. The Court can disregard the defence experts but that’s rare.

    The professional negligence bar is set high and it’s difficult to prove failure to provide even a minimum acceptable standard of care.

    Here is Hunter v. Hanley for those who are interested:

    THE “HUNTER v HANLEY” LIABILITY TEST & PRACTICAL ISSUES ARISING

    A.S. POLLOCK

    This is a brief summary for the benefit those in the Group who may be unfamiliar with the Hunter v Hanley legal test.

    The general test for non-clinical / non-professional negligence:
    Under Scots Law, there is a general duty on all to take reasonable care. This duty applies to most ordinary day to day activities of any person. It applies to the driver of a car, just as it applies to employers, and any member of the public. This quite simply means what it says – the test is one of “reasonable care”. The most famous case is Donoghue v Stevenson (a case involving a snail found in a bottle of ginger beer in Paisley) where it was held by the House of Lords that a duty to take reasonable care is owed to everyone who is one’s “neighbour”, a “neighbour” being, in essence, any person likely to be closely and directly affected by the failure to take reasonable care.

    This is a very wide test and it underpins the common law in Scotland and indeed throughout the UK.

    The test for clinical negligence:
    However, this is not the test for clinical negligence. The test of clinical negligence is a higher test. The test is whether the doctor has been guilty of such a failure as no doctor of ordinary skill would be guilty of if acting with ordinary care. In other words, a mistake made the doctor must be a mistake which no competent doctor in that field would have made. For nurses and other medical professionals simply substitute the word “nurse” or whatever for “doctor”. This is the Hunter v Hanley test and is usually set down as a threefold test:-
    1. There must be a usual and normal practice (i.e. by the doctor);
    2. The doctor has not adopted that practice; and
    3. The course adopted is one which no professional man (i.e. doctor) of ordinary skill in that field would have taken if acting with ordinary care.

    In simplistic terms, a mere “mistake” will not mean that a doctor is liable. The mistake has to be more akin to a “blunder” (the Oxford English Dictionary definition of “blunder” and not the Daily Record definition!). It is crucial to note that a doctor will only be deemed negligent if he or she has failed to meet the minimum acceptable practice. A failure to meet best practice is not enough.

    England – the Bolam test:
    In England, the Hunter v Hanley test has been approved and a similar test is followed in England. In England, the test is called the “Bolam” test.

    The Specialist:
    A Specialist, such as a Consultant, is to be judged according to the standard of the ordinary competent member of that specialism, i.e. a Consultant.

    Junior Doctors:
    A junior doctor similarly will be judged according to the standard to be expected of a junior doctor in that post. For example, the Junior House Officer will be judged according to the standard to be expected of a JHO of ordinary competence.

    Relevant Expert:
    It is always necessary to obtain a “like for like” Expert Report. For example, if a GP has negligently failed to refer a patient for investigation of breast lumps which turn out to be breast cancer, an Expert Report from a breast surgeon on whether the GP was negligent will be irrelevant. An independent GP will have to prepare a “like for like” Report on the actings of the GP.

    The Defence:
    The doctor (in Scotland and in England) will have a defence if, as set out in the case of Bolam, “the doctor has acted in accordance with a practice accepted as proper by a responsible body…”. In practice, the doctor simply needs to produce a Report from another Expert to say that his course of action was accepted as proper by “a responsible body” of professional opinion. If there are two different Experts as to what is acceptable practice, the Court is not allowed simply to prefer one over the other. The Court needs to consider the two sets of Experts and then consider whether there is a logical basis for what the Expert says. The Court will have to have some basis for disregarding the Defender’s expert.

    The Bolitho exception:
    In reality, if the defence produce an independent Expert who says that the actings of the doctor would be regarded as proper by a responsible body of medical opinion, the Pursuer has an uphill struggle. The Defenders will not automatically win however. The Court can disregard the view of the defence expert if the Court is not satisfied that there is a logical basis for that expert’s “body of opinion”. However, this is a limited exception and is not often encountered in practice.

    Conclusion:
    The test for professional negligence sets the bar at a high level. In reality, it has to be proven that no doctor of ordinary competence in that particular field would have made the mistake in question. It is not based on a failure to follow best practice. It is not even based on a failure to take ordinary care (which is the wider legal test for non-professional negligence cases). It is based on a failure to provide a minimum acceptable standard of care. What frequently will happen in practice is that an independent medical expert will say “This is not what I would have done, but I cannot go as far as to say that no competent practitioner in my field would have acted in this way.”.

    Consequences of the error:
    In deciding how bad the error is (i.e. whether it is a “blunder” rather than a “mistake”), the consequences of the error generally are not taken into account. The best analogy is with driving – careless driving is still careless driving whether someone is killed in the accident or whether by luck only minor injuries are suffered. The degree of carelessness remains the same.

    Causation:
    It is important to note that to prove any case of medical negligence, there are two hurdles to overcome.

    The first hurdle is to prove negligence, as indicated above (“liability”). However, merely showing negligence is not enough. It is also necessary to overcome the second hurdle which is the “causation” hurdle. It is necessary to show what difference the negligence made and to obtain a report from the relevant expert. So, in the example above of the negligent GP failing to refer a patient for investigation of breast lumps which turn out to be breast cancer, an Expert Report from a GP on whether the GP’s negligence made any difference to the development of the cancer will be irrelevant – a separate report will be required from a breast cancer specialist as to whether or not this made any difference to the condition and prognosis.

    If the negligence did not make any difference to the outcome then there is no claim. In practice, as many cases fail on “causation” as they do on “liability” i.e. negligence but a detailed discussion on causation is beyond the scope of this paper.

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