The Pandemic That They Tried to Hide
Hi there everyone,
Thanks for taking the time to read my story and why I am fundraising.
I am a MESH Victim since 2012 and have been fighting ever since to be believed and listened too.
Like many MESH Victims we feel like this is a pandemic that has been ignored by the Government and the NHS.
Unfortunately there are no longer a MESH Unit for care, treatment or removal here in Northern Ireland and therefore I am having to look further afield and in particular America.
There is obviously substantial costs involved hence why after much thought and consideration I have decided to start a go fund me page.
I have lost so much due to MESH and no longer feel like the person I was before and NOW I'm fighting back and want this horrible horrible device removed from my body.
Once I am able to have surgery I intent to give back and in doing so I want to start a charity that will offer help, guidance and assistance to not just MESH Victims but also their family and friends. Ideally I would like the charity to begin by purchasing a static caravan and offer holidays and days out to those who have struggled with quality family time - give them a place to create new memories. I would also like to train as a councilor based on my experience and help people through this very very nasty and unpleasant journey I believe my knowledge is invaluable and will offer help and guidance that is not currently available to MESH Victims.
MESH will not destroy me and I wouldn't allow it to destroy others and their families.
If you are intrigued and want to learn more please just reach to me.
Here's some more in-depth info:
MESH SURGERY – CONDUCTED DECEMBER 2012
After a number of consultations with my Gynae Doctor it was suggested that I should have a Vaginal sling procedure that would help control stress urinary incontinence. This was due to urine leakage that was occurring when I laughed, coughed, sneezed, lifted things, or exercised. I was told that the procedure would help close my urethra and bladder neck.
The surgery took place on 7th December 2012 I was told the procedure would take a couple of hours and I would be discharged the same day.
This was not the case at all.
When I came round from surgery my Doctor approached me to discuss the surgery, he confirmed that they had a used a new method called MESH.
In a letter to my GP my Gynae Doctor stated:
“The whole procedure was performed uneventfully, and the patient will be discharged later today. She will be reviewed in 2 months’ time.”
This is incorrect – I ended up staying in overnight due to the inability to stand due to severe pain in my right leg. When I went to get out of bed or walk I fell to the floor due to the sheer pain.
My problems/issues with the MESH where experienced immediately from the moment it was placed in my body.
Follow-Up Appointment 2 Months After Surgery:
7th February 2013 the Gynae Doctor stated in his letter to my GP:
“She has still got persistent leg pain. She takes Paracetamol when the pain is quite bad. I have recommended Voltarol and Brufen.” “She has a degree of cramps and feels that this pain is 8/10 which seems to be quite a significant problem, this may be due to adenomyosis.”
It took until 2nd January 2019, and numerous appointments, for my GP to actually listen to me and realise that something was REALLY wrong and that it wasn’t womanly problems or muscle damage as it had so commonly been put down to!
EFFECTS ON MY LIFE
I have been left disabled for life:
• • I have lost my health
• • My job
• • My purpose in life – I have lost everything.
Why was I given the MESH – simple – this was due to stress urinary incontinence following childbirth. However, MESH was not the surgery I was lead to believe I was having I thought I was having a Sling Procedure. Yet when I came round from surgery, I was informed they have used this new wonder devices known as MESH.
My daughter, Jessica (12), often asks me:
“Mummy is it my fault you have MESH?”
This should be what an 11-year-old is worrying about, and this is guilt that I then absorb every second, of every hour, of everyday.
Jessica has a beautiful spirit; a very loving and caring nature and it is unfair for her to carry my burden and help be my carer for something that could have been avoided.
A pelvic MESH implant has ruined my life, my husband’s life and my daughter life.
Doctors dismissed me on numerous occasions, between December 2012 and January 2019, as a hysterical woman – when all along my body was being destroyed and ripped apart by MESH.
I have endured, over 8 years of pain due to the MESH implant and this harm was avoidable yet our concerns have continually been dismissed and overlooked.
I feel that the behaviour by many professionals who I have reached out to over the years has been reckless and woman have been abused and derisived by many. Physicians became arrogant and this resulted in disdain for females.
My life has been catastrophically affected by the mistakes that have been made and which could have clearly been avoided.
My self-worth is on the floor. I was once the most outgoing, bubbly individual and now I have no self-esteem or energy for life. I often cry myself to sleep hoping that I wouldn’t wake up in the morning and will no longer be in pain. Hobbies are no more – I used to sing, act and dance in amateur dramatic shows and can no longer fulfil that passion. I am filled with dread and anxiety at the thought of leaving the house.
I feel sad and disheartened that it took so long for a report to be compiled when woman around the world where fighting to have their voices heard but yet I am relieved that I am finally being believed and listened to and that I’m just not a hysterical middle-aged woman.
For a long long time I was dismissed by health professionals who said my health problems where nothing to do with the MESH – but how could they be so confident when so little was known about the MESH. It has become apparent over the years that their knowledge of this device was non-existent.
Even when visiting A&E (which has become a regular occurrence) and I would mention the MESH nurses and doctors would ask me what it is as they had never heard of it. Often, they would be seen Googling it whilst I lay in a bed in agonising pain.
I am no longer the person I was before the MESH. I am now a statistic and a part of history who will hopefully save future victims from the pain and trauma that I have endured.
WHAT IS MESH?
Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. The majority of surgical mesh devices currently available for use are made from man-made (synthetic) materials or animal tissue.
Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement in strength to the urogynaecology repair.
Surgical mesh has been used for urogynaecology procedures, including repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). It is permanently implanted to reinforce the weakened vaginal wall for POP repair or support the urethra or bladder neck for the repair of SUI.
There are three main surgical procedures performed with surgical mesh to treat pelvic floor disorders with surgical mesh:
Transvaginal mesh to treat POP *
Transabdominal mesh to treat POP
Mesh sling to treat SUI
Each of these procedures has unique risks and benefits and it is important not to confuse the procedures and their risks and benefits.
The MESH scandal has come about and been created by surgeons and doctors in power have ignored woman and their symptoms.
Unlike the stringent requirements for drug testing which can delay the introduction of new treatments for up to a decade, the only requirement for a medical device is that it has an CE Mark to confirm that it confirms to EU Safety Standards.
This is a device to be placed in the human body yet there is no rules for stringent testing!
US lawyer, Adam Slater, the lead trial counsel in the first pelvic MESH trial against Johnson and Johnson, is on record as saying, “The closest analogy is that MESH implants are as dangerous as asbestos and women were not told the truth about the devices before implementation”.
He recognises that it was designed to ease incontinence but that it is undeniable the painful complications that come with the device.
Originally MESH was hailed as a wonderful invention yet now it is seen as something you wouldn’t want to go near and that it is actually a horrible device. One doctor has even branded MESH devices as a ‘social cancer’.
Vaginal MESH implants are a cause of crippling, life-changing complications, and unbearable pain.
MESH is a prime example of misogyny in medicine. The product should have never been approved or marked until it was clear what impact it could have on woman.
It is supported by a weak scientific base where short term studies where generally supported by the industry.
In short, the system does not know the true, long-term complication, rate for pelvic MESH procedures.
MESH Timeline:
• 1998
Tension-free vaginal tape becomes available in the UK
• 2003
UK Health Watchdog (NICE) says only surgeons should operate with procedures and outcomes audited
• 2011
US Watchdogs issued a safety warning and legal actions began
• 2014
Scotland suspended MESH Procedures amid more safety concerns
• Feb 2018
UK Government launched safety review
• July 2018
The review called for a halt to the use of MESH to treat urinary incontinence
• 2019
NICE says vaginal MESH Implants can be offered again by specialist surgeons.
• July 2020
Review demands a public apology and calls for a national database for MESH surgery and specialist centres for removal.
While clinicians have undoubtedly been getting better in recent years at listening to their patients, there remains a lot of room for improvement.
As patients we faced a wall of denial – now we need action. We have spent too many years being fobbed off and dismissed.
MESH should only be used as a last resort and not as freely as it has been in recent years. Women have been hurt by MESH – physically, mentally, and emotionally. Since 2011 hundreds of women who were implanted with faulty vaginal MESH have spoken out but were ignored and pushed aside.
Thousands of women are suing manufacturers and doctors on the grounds that MESH devices are defective and that there was a failure to warn patients about the dangers and complications that could be endured after insertion.
In April 2019 the FDA indicated that it planned to reclassify MESH for pelvic organ prolapse as ‘high risk’ but as of yet this has not been done. After the MESH has been inserted the scar tissue causes MESH to shrink and contract/pull on the tissue in contact with the MESH. The MESH is scarred into place and is a permanent fixture. MESH needs to be a flexible object in the pelvis around the vaginal, bladder, urethra structures that needs to move in very subtle way. A hard object will cause a cascade of problems.
JOHNSON & JOHNSON | FINANCE
Alex Gorsky the chairman and CEO of Johnson & Johnson, and chairman of the executive committee, the company’s senior leadership team is on record as saying:
“we take our reputation as leader in the health sector very seriously, human healthcare is the very basis of our business. We measure our success by improving the quality of people’s lives”.
However, in my case my quality of life has been totally and utterly destroyed!
Before taking on his role as the head of Johnson & Johnson, Alex Gorsky, served a period of time as the head of Ethion and on his watch he was flooded with information coming into the company of woman suffering complications of MESH.
On Sunday 21 September 2012, Alex Gorsky, was asked when he made aware of this information and his response was – never.
As per Johnson & Johnsons annual report of 2017 in the past decade, MESH lawsuits have cost Johnson & Johnson more than $3 million. During that time Johnson and Johnson total revenue has exceeded $683 billion.
Currently in the USA there are 4 states suing Johnson & Johnson for concealing the dangers of vaginal MESH.
It is also on record that before MESH came to market the surgeons creating the proto-type stressed to Johnson & Johnson that the MESH was NOT safe and no fit for human use.
Doctor Piet Hinoul, VP of Medical Affairs, for Ehticon and Johnson & Johnson acknowledged on record on 6th April 2012 that Johnson & Johnson knew about serious risks including chronic pain and pain with sexual intercourse ‘from day one’, but chose not to disclose these risks to patients.
Johnson & Johnson knowing deception caused women to suffer in deeply personal ways.
Johnson & Johnson sold MESH devices on the basis of how safe it would be and how wonderful it was – yet they had no basis for this.
It costs around $25 per MESH Device to produce and bring to the market and yet is sold within the medical market for $2000. It was and is sold on the basis of being a superior surgery to traditional surgery which is very easy to place and with few complications.
Scientists involved in the develop of MESH and who wanted to do the right thing highlighted concerns of the danger that the MESH could bring but marketing, as always, overruled the concerns and the product was brought to market.
I am unable to afford private removal due to the sheer costs and just must patiently wait my turn and continue to suffer every second of every hour or every day – 365 days a year.
PERSONAL MESH EFFECTS THAT I EXPERIENCE:
• Chronic pain
• Permanent leg and hip problems
MESH erosion
• Nerve damage
• Pain walking
• Soreness inside ears
• Urinary urgency and frequency
• Anaemic
• Pain when sitting (only comfortable lying down)
• Bladder spasms
• Severe fatigue
• Hives
• Chronic hip pain
• Blood in urine
• IBS
• Difficulty swallowing
• Bloating
• Vitamin defiency
• Chronic reoccurring leg pain
• Suicide Ideation
• Discomfort during sex
• Continual thrush
• Brain fog
• Weight gain
• Urinary incontinence
• Vaginal bleeding
• Anxiety
• Hair loss (thinning of hair)
• Constipation
• Recurring urinary tract infections
• Skin sensitivity
• Buttock pain
• Migraines
• Lack of sleep
• Nausea through lack of sleep
• Restless legs
• Excessive sweating
• Erosion of bladder, urethra and bowel
• Night sweats
• Pelvic Pain
• High blood pressure
• Abdominal pain
• Skin rashes
• Depression
• Never damage in groin
• Difficulty emptying bowel/bladder
• Numbness in legs and feet
• Burning pain
• Severe dry eyes
• Inflammation
• Legs – feel heavy to lift / climb stairs
• Mouth uclers / gum disease
• Lower back pain
• Hand pain
• Fibromyalgia
• Headache
• Difficulty urinating
• Sharp pain between pubic bone and leg
• Unexplained rashes / skin issues
• Tinnitus
• Obturator nerve damage causing severe thigh pain
I am 42 and now have limited mobility – I rely on a stick, wheelchair and mobility scooter due to my mobility being so limited.
Unable to sit for periods at a time and therefore unable to hold down a job.
Unable to play with my daughter and take part in family outings.
The side effects have caused fractured relationships with my husband, family, and friends.
I lost my job (my dream job which I worked hard for) and this has impacted on us by now being in financial straits.
I will never be the same person again that I was before the MESH and I no longer feel like a woman. I feel like I have no control over my body and all.
A quote from Sling the MESH Campaign:
“All women’s pelvic mesh has the potential to cause serious, life changing, irreversible damage to women. The longer the time goes on the more women will start coming forward suffering as mesh has the potential to sit like a ticking time bomb for years. Sling The Mesh demands a 20 year retrospective audit to work out the true scale of this horrendous women’s health scandal.”
Training has only ever been given on how to insert the MESH but not the removal of it. Medical knowledge of the product is not sufficient this is obvious when you visit A&E and they have to Google what you tell them as they have never heard of the device.
There is no guarantee that the MESH can be removed in its entirety and perhaps not at all. It has been likened to trying to remove chewing from hair – nearly impossible.
MESH DEVICE – 810081L
As per the Ethicon website this information is currently available which wasn’t available in 2012 when I have my surgery:
https://www.jnjmedicaldevices.com/en-US/product/midurethral-sling-vaginal-tape-obturator
My MESH should be sitting in the pelvic area in a v-shape as per the picture below however after a translabial scan it shows that the MESH is sitting like this -------- and is therefore too tight and causing many of my issues.
GYNECARE TVT™ FAMILY OF PRODUCTS
GYNECARE TVT™ Transobturator Midurethral Sling Vaginal Tape Obturator System
GYNECARE TVT Obturator System is a transobturator mid-urethral sling used for the treatment of female stress urinary incontinence. There are fewer overall complications than with other transobturator procedures.1 The device is proven in two 5-year follow-up studies.
ESSENTIAL PRODUCT INFORMATION
INDICATIONS
The GYNECARE TVT™ Tension-free Support for Incontinence, GYNECARE TVT EXACT® Continence System and GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence, are intended to be used in women as pubourethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
GYNECARE TVT™ Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVO® Continence System are intended to be used in women as sub-urethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
CONTRAINDICATIONS
- As with any suspension surgery, these procedures should not be performed in pregnant patients.
- Additionally, because the PROLENE Polypropylene Mesh will not stretch significantly, it should not be performed in patients with future growth potential including women with plans for future pregnancy.
WARNINGS & PRECAUTIONS
- Do not use the GYNECARE TVT Family of Products in patients who are on anti-coagulation therapy.
- Do not use the GYNECARE TVT Family of Products in patients who have a urinary tract infection.
- Bleeding or infection may occur post-operatively.
- Transient leg pain lasting 24-48 hours may occur and can usually be managed with mild analgesics after a GYNECARE TVT Obturator System or GYNECARE TVT ABBREVO System procedure.
- Since no clinical information is available about pregnancy following sub-urethral sling procedure with the GYNECARE TVT Family of Products, the patient should be counselled that future pregnancy may negate the effects of the surgical procedure and the patient may again become incontinent.
- Since no clinical information is available about vaginal delivery following sub-urethral sling procedure with the GYNECARE TVT Family of Products, in case of pregnancy, delivery via caesarean section should be considered.
- Post-operatively, refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least three to four weeks and to refrain from intercourse for one month. The patients can usually return to other normal activity after one or two weeks.
- Contact your surgeon immediately if there is burning sensation during urination, unusual bleeding, problems voiding or other problems.
PATIENT FACTORS
Physicians should use their surgical experience and judgment to determine if PROLENE Mesh is appropriate for certain patients. Patient-specific factors may impair wound healing, which may increase the likelihood of adverse reactions.
ADVERSE REACTIONS
- Punctures or lacerations or injury of vessels, nerves, structures or organs, including the bladder, urethra, or bowel, may occur and may require surgical repair.
- Improper placement of the GYNECARE TVT Family of Products devices may result in incomplete or no relief from urinary incontinence or may cause temporary or permanent urinary tract obstruction. - Transitory local irritation at the wound site may occur.
- As with any implant, a foreign body response may occur. This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation.
- Mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
- As with all surgical procedures, there is a risk of infection. As with all foreign bodies, PROLENE Mesh may potentiate an existing infection.
- Acute and/or chronic pain.
- Voiding dysfunction.
- Pain with intercourse which, in some patients may not resolve.
- Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur.
- Recurrence of incontinence.
- Bleeding including haemorrhage or hematoma.
- One or more revision surgeries may be necessary to treat these adverse reactions.
- PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required.
OTHER ADVERSE REACTIONS
- Seroma
- Urge incontinence
- Urinary frequency
- Urinary retention
- Adhesion formation
- Atypical vaginal discharge
- Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse.
- Death
ETHICON eClinical Compendium – Article Summary
_________________________
©2018 Ethicon US LLC. All Rights Reserved 034057-180419
Title A Real-World Comparative Assessment of Complications Following Various Mid-Urethral Sling Procedures for the Treatment of Stress Urinary Incontinence
Author(s) Magee G, Roy S, Hinoul P, Moretz C, Kozarev R, Waters H, Whitmore K
Source Journal of Long-Term Effects of Medical Implants, 22(4), 329-340.
Key Takeaways
Stress urinary incontinence (SUI) affects a significant proportion of the adult female population in the US, with the prevalence increasing with age. Mid-urethral slings are among the surgical options offering important improvement in SUI. The most common surgical treatment for SUI today is a synthetic mid-urethral sling (MUS).
This study evaluated surgical outcomes of patients treated with GYNECARE TVT™ Family of Products
(ETHICON, US LLC) in comparison to other MUSs produced by other manufacturers when comparing
both retropubic to each other as well as transobturator brands to each other.
Transobturator vs. Retropubic Approach
Overall, fewer complications were noted with the transobturator procedures than the retropubic
procedures.
Retropubic Brands Compared
Patients in the retropubic category treated with GYNECARE TVT™ Tension-free Support for
Incontinence (TVTR) had a significantly lower rate of urologic complications (6.6% versus 9.1%; p =
0.002), primarily driven by lower rates of urinary obstruction/retention (2.0% versus 3.7%; p < 0.001) and urinary tract infection (4.7% versus 6.0%; p = 0.049 compared to patients treated with other retropubic slings (ORS). Even after statistical adjustments of the baseline the rates of urinary obstruction for TVTR remained significantly lower.
Transobturator Brands Compared
In the transobturator group differences were noted in the rate of pelvic complications (6.5% versus 8.1%;p = 0.007). The difference appears to be driven by lower rates of dyspareunia, pelvic pain, and related symptoms (1.4% versus 2.0%; p = 0.046), as well as injury to blood vessels, nerves, or viscera (4.1% versus 5.2%; p =0.023) in the TVTO subgroup. There were lower rates of dyspareunia, pelvic pain, and related symptoms and injury to blood vessels, nerves, or viscera with GYNECARE TVT™ Obturator System (TVTO) compared to the other transobturator slings (OTS). Even after adjusting for differences in demographic factors, rates of overall pelvic complications as well as urologic complications, were lower in the TVTO subgroup versus the OTS subgroup.
Study Limitations
All utilization and complication rates relied on coding for each patient. Codes may be underestimated or missed altogether; therefore rates of complications shown in the study may be underestimated. There may be differences in coding between hospitals. Also, the outpatient information is limited to hospital outpatient facilities and did not capture treatment received in the physician’s office. This study was limited to a one year post procedure follow up due to the low number of eligible patients with longer follow up.
Summary
Complications associated with the use of GYNECARE TVT™ Family of Products may be lower due to
the differences in the sling material, which offers greater flexibility for placement while still offering
appropriate tensioning. It should also be noted that the findings of this report support recent meta analysis reports that revealed “inside-out” method of placement with the GYNECARE TVT™ Obturator System is associated with fewer bladder injuries and voiding difficulties than transobturator tapes placed via the “outside-in” method.
STUDY OBJECTIVE:
To evaluate the clinical outcomes of GYNECARE TVT™ Family of Product slings in comparison to other MUS products, including a comparison of perioperative and postoperative complications.
METHODS:
This retrospective study utilized data from the Premier Perspective Database for mid-urethral sling procedures between January 1, 2005 and December 31, 2009. Patients were grouped into retropubic or transobturator cohorts, and these cohorts were further divided by the brand of sling utilized during the procedure. A total of 6361 patients were identified as having retropubic sling procedures, of whom 5007 were in the GYNECARE™ brand subgroup, and 1354 were in the other retropubic slings (ORS) subgroup. A total of 9754 patients were identified in the transobturator sling cohort, with 2895 in the GYNECARE™ brand subgroup and 6859 in the other transobturator slings (OTS) subgroup. Surgical outcomes and 12-month complication rates were assessed.
OUTCOMES MEASURED:
• Sling failure / SUI reoperation within 1 year surgery
• Revision or removal of sling
• Urologic complications (including urgency incontinence, urinary obstruction/retention, i.e., diagnosis or
• intervention, and urinary tract infections)
• Pelvic complications (including dyspareunia, pelvic pain and related symptoms, fistula diagnosis or
• interventions, wound-related complications, injury to blood vessels, nerves, or viscera, i.e., diagnosis or
• intervention, other abdominal complications’ diagnosis or intervention, other complications attributable to
• procedure, device, graft, or implant, pelvic organ prolapse diagnosis or intervention)
• Urologic investigations (including cystoscopy, imaging studies, and urodynamics
RESULTS:
RETROPUBIC SLINGS:
• Both subgroups of patients treated with retropubic slings demonstrated a low rate of failure/SUI reoperation within one year post surgery (less than 2% in each subgroup).
• Patients treated with a retropubic GYNECARE™ brand product had a significantly lower rate of urologic complications (6.6% versus 9.1%) compared with patients treated with other brands.
• Driven by lower rates of urinary obstruction/retention (2.0% versus 3.7) and urinary tract infection (4.7% versus 6.0%) among the TVTR subgroup compared to the ORS subgroup.
• There were no significant differences in the categories of pelvic complications or urologic investigations between the subgroups.
• • Multivariate analysis in the retropubic cohort was conducted for urinary complications and pelvic complications
• • This subcategory of urinary obstruction demonstrated a significant difference in the odds ratio with TVTR patients having about half the odds of experiencing urinary obstruction compared to the ORS group.
TRANSOBTURATOR SLINGS:
• Both transobturator treatment groups demonstrated a low rate of failure/SUI reoperation within one year post surgery (less than 1% in each subgroup).
• The TVTO subgroup had fewer urological complications than the OTS subgroup (4.9% versus 7.6%).
• The difference appears to be driven by lower urinary tract infection rates (3.7% versus 5.5%) and lower incontinence rates (0.2 % versus 1.2 %) in the TVTO subgroup.
• No differences in urinary obstruction/retention were observed between the groups.
• The TVTO subgroup had significantly lower rates of pelvic complications that the OTS subgroup (6.5% versus 8.1%).
• The difference is driven by lower rates of dyspareunia, pelvic pain, and related symptoms (1.4% versus 2.0%) as well as injury to blood vessels, nerves, or viscera (4.1% versus 5.2%)
• The TVTO subgroup demonstrated lower likelihood for urologic and pelvic complications compared to the OTS subgroup.
• The odds ratio of urgency incontinence and urinary tract infection were also significantly lower.
STUDY LIMITATIONS:
The retrospective design of this study, which lacked baseline evaluations, may pose an inherent limitation to the study. All utilization and complication rates relied on coding for each patient. Codes may be underestimated or missed altogether; therefore rates of complications shown in the study may be underestimated. There may be differences in coding between hospitals. Also, the outpatient information is limited to hospital outpatient facilities and did not capture treatment received in the physician’s office. This study was limited to a one year post procedure follow up due to the low number of eligible patients with longer follow up.