Posts Tagged ‘vaginal mesh complications’

Dyspareunia Or Painful Sexual Intercourse Identified As One Of Most Serious, Common Complications

Tuesday, January 21st, 2014

In the vaginal mesh trials that have been concluded so far, the subject of dyspareunia or painful intercourse has been shown to be a very crucial issue. Dyspareunia has been a cause of great concern since this is one of the most common complications attributed to the use of vaginal mesh devices, aside from the very significant effect it has on the lives of thousands of women.

 

Incidence of Dyspareunia

 

In a study conducted by a group of medical researchers from the University of Nijmegen Medical Center in the Netherlands, it was determined that pelvic pain after surgery was reported by 13 percent (35 out of 275) of the patients while 45 percent (77 out of 171) were found to have experienced dyspareunia. This was the result of a research involving 294 patients who had vaginal mesh surgeries who were evaluated six weeks, six months and a year after surgery.

 

Associated Pains

 

If experiencing pain during sexual intercourse is not enough, a woman with dyspareunia as result of mesh complication may also have to endure other symptoms. Pain in the vagina, groin, and buttocks go hand in hand with dyspareunia in most cases. Closely associated with this complication are other problems such as heavy bleeding, vaginal discharge, organ perforation, and infections.

 

Management of Dyspareunia

 

Treatment of this condition, in almost all cases, may require a surgical procedure to remove the implanted mesh. To make matters worse, this may require removal of all the mesh and not just a portion. This procedure has been acknowledged by pelvic surgeons to be very complex and difficult, which may only put additional risks on the patient.

 

Studies conducted on mesh removal have shown that not all women will be relieved of the pain despite the complete removal of the mesh. Results of a research conducted by Dr. Erin Crosby of the University of Michigan in Ann Arbor, Michigan and presented during the annual scientific meeting of the American Urogynecologic Society (AUGS) showed that at least 25 percent of the patients who had mesh excision still experienced dyspareunia even after a number of operations. The risk increases if the removal of the mesh is performed after a long period from date of vaginal mesh surgery.

 

Effect of Dyspareunia on Relationships

 

As a result of this complication, countless relationships have been sacrificed, as confirmed by numerous reports. Dyspareunia is a valid issue that must be faced by those responsible even if some may find it trivial.

 

Thousands of women who suffer dyspareunia and other complications as a result of using mesh implants may have every right to file vaginal mesh lawsuits in order to be compensated for their suffering and other damages. Several pelvic mesh lawsuits have been lined up for hearing this year after a number of claims were resolved or settled out of court in 2013. Among those expected to be heard is the fourth bellwether trial against C.R. Bard after the court denied Bard’s request to exclude internal memos in the trial.

 

References:

uptodate.com

ncbi.nlm.nih.gov

medscape.com

Severe Complications Of Vaginal Mesh Surgery Include Mesh Erosion, Pain, Infections

Thursday, January 16th, 2014

The emergence of transvaginal mesh devices was believed to be the latest innovation in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), two pelvic floor disorders that affect millions of women. Now, thousands of women have been exposed to grave danger just because they have been convinced to use these mesh devices to treat conditions that were not considered life-threatening. Instead of improving their quality of life, these women right now face endless pain and misery as a result of severe complications.

 

The following are the common complications associated with the use of vaginal mesh devices:

 

Mesh Erosion/Exposure

 

Among the many possible adverse effects, mesh erosion may be the most common and the most serious of all. If the mesh erodes into the bladder or rectum, there will be terrible pain in the affected areas, blood in the urine and stool, recurrent urinary tract infections, urinary incontinence, fistula formation, abscess formation in the vagina, and possible infections in multiple organs of the body. A surgery to remove the mesh, in most cases, may be required without a guarantee that all the mesh will be removed.

 

A patient may experience mesh erosion as soon as two weeks after a surgical procedure or it may take years before symptoms may appear, especially when the mesh erodes into the colon or rectum. In a lot of cases, mesh erosion may only be detected during sexual intercourse where the woman or her partner may feel extreme pain during penetration.

 

Chronic Pain (Including Dyspareunia)

 

Chronic pain and discomfort, in part due to the erosion of the mesh, may become a daily component of a patient’s misery. This pain and discomfort, which has been described as devastating, may affect a woman’s ability to perform even the most mundane tasks. The disruption or the entrapment of the nerve fibers, which may have been stimulated by the mesh, has been attributed by doctors as the cause for this complication.

 

Almost all parts of the pelvic area, particularly the groin and buttocks, may be experience this pain. Majority of women have also reported experiencing great pain during sexual contact. It has been revealed by one study that over 90 percent of patients were relieved of pain upon the removal of the mesh.

Serious Infections

 

One of the most common complications reported by numerous patients after a vaginal mesh repair was the onset of infections. Due to these infections, a woman may encounter a general discomfort that may affect her day to day activities, in addition to the severe pain. She may find it very difficult to stand or to sit and without medications, walking may become impossible.

 

A patient may be at risk of suffering septic shock, a life-threatening condition, if these infections get worse. This occurs when the infection spreads into the blood causing serious symptoms to appear in the patient’s whole body.

 

Recurrent Prolapse or Incontinence

 

After a procedure involving the transvaginal mesh repair of an organ that has prolapsed, it may not be uncommon to see patients develop incontinence and other urinary problems. This may come in the form of difficulty in urinating, urinary tract infections, the need to urinate frequently, and experiencing leakage when stress is exerted in the abdominal area. Having to deal with other forms of pelvic floor disorders after undergoing surgery to treat a related condition can be very frustrating to a woman.

 

Other Adverse Effects

 

While these four complications may have been reported as the most common, patients may also experience other equally dangerous adverse effects. Other severe complications may be manifested in the form of mesh shrinkage, organ perforation, neuro-muscular damage, heavy bleeding, constipation, and even emotional problems.

 

Thousands of women have sustained serious injuries leading to pain and suffering, permanent disability, and substantial deformity due these very dangerous complications. Legal actions such as filing of vaginal mesh lawsuits against mesh manufacturers have been resorted to by these women as a result of these injuries. Hearings of these claims have been scheduled in courts with the upcoming bellwether trials in West Virginia foreseen to have significant implications on the pending vaginal mesh lawsuits.

 

Reference:

fda.gov

c.ymcdn.com

meshsurgeons.com

 

hindawi.com

Mesh Removal Specialist Talks Of Vaginal Mesh Complications

Thursday, December 5th, 2013

Credit was also given to Dr. Michael Margolis when the Scottish government carried out positive measures against the use of vaginal mesh surgery for the repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), through his letter sent to the Minister of Health and Wellbeing, reports from online sources say. Dr. Margolis has always been an advocate against the use of polypropylene mesh for the repair of prolapse and urinary incontinence, with his over 20 solid years of experience as a well-known pelvic reconstructive doctor to back him up.

 

Very important points against the use of vaginal mesh implants were raised by Dr. Margolis in his letter to Minister Alex Neil, using his experience in removing over 200 mesh implants since the introduction of polypropylene mesh to the American market in the mid-1990s. He enumerated the different complications suffered by women who have sought his assistance for mesh removal surgeries. He emphatically mentioned that the complications from this defective surgical theory and defective material far outweigh the potential benefits.

 

He strongly stressed that the use of transvaginal polypropylene mesh for the repair of POP and SUI must be stopped immediately. This type of surgical procedure is bound to fail since it involves inserting the mesh through the vagina which is a clean contaminated field and not a sterile surgical environment.

 

The use of vaginal mesh implants may result to complications during the course of the surgical procedure or a period after the implantation of the vaginal mesh device. These complications may appear after a number of years has passed or as early as a few months after the operation.

 

Sustained during actual implantation of the vaginal mesh device, he relayed how he has treated patients with injuries to the bladder, bowel, blood vessels, and vagina. Severe complications experienced by women after mesh operations included mesh erosion, chronic infection, vaginal scarring, chronic pain, morbid disfigurement, and loss of function of the vagina.

 

Largely due to the contraction of mesh, late complications may not be uncommon which may emerge in the form of permanent injuries to surrounding organs such as the vagina, urinary tract, and the bowel. Relationships have likewise been put to the test, with several marriages disintegrating due to the loss of consortium brought about by damage to the vagina. Dyspareunia or pain during sexual contact has in fact been listed as one of the most common complication associated with vaginal mesh surgery.

 

Most important of all, he underscored the point that there are several traditional methods of repair that have success rates equal or superior to vaginal mesh surgeries.  This point has been strongly supported by a recent study which found TVM surgery no more effective than traditional methods.

 

References:

meshmedicaldevicenewsdesk.com

meshgonewrong.com

 

Learning The Main Causes Of PFD In Menopausal Women

Saturday, November 30th, 2013

Medical experts have long accepted menopause, along with pregnancy and childbirth, as one of the primary reasons for the occurrence of pelvic floor disorders (PFD), particularly stress urinary incontinence (SUI), the most common form of PFD. SUI is foreseen to be experienced by more than 40 percent of women in the menopausal stage and by the time they reach 80 years of age, the risk of surgery will be 20 percent.

 

Reasons for this occurrence are presented below to allow women to gain an understanding and hopefully help them in addressing these life-altering conditions:

 

Weak Pelvic Floor Muscles

Just like the rest of the muscles in the body, the pelvic floor muscles also start to weaken and lose mass as one gets older. Studies have shown that muscle strength deteriorates by five percent every decade after the age of 30. This ageing process is also closely tied with menopause with women experiencing this stage between the ages of 45 and 55 years.

 

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) may result when the pelvic floor muscles lose strength since it may not be able to support pelvic organs such as the bladder and bowel causing these to descend or drop from their normal positions towards the vaginal wall.

 

Bladder Becomes Less Elastic

As a woman ages, the bladder may also become less elastic, just like the weakening of the muscles. This loss of elasticity may irritate the bladder making it difficult to stretch causing the muscles of the bladder to be overactive. Stress incontinence or frequent urination may result which is made worse by the weakening of the pelvic floor muscles.

 

Vaginal Dryness

Menopause has been associated with the loss of the hormone estrogen. Once the level of estrogen drops, vaginal dryness in the vaginal lining and urethra may be experienced by the woman. The onset of incontinence and other pelvic disorders such as urinary tract infections may be hastened with this dryness.

 

Gain in Weight

Women start gaining weight as they grow older, even before the onset of menopause. Due to several other factors, this weight gain becomes more pronounced as women enter the menopausal stage.

 

Any additional weight may tend to put a strain on the pelvic floor muscles which may result to the weakening of these muscles. The muscles may not be able to support the bladder and bowel leading to incontinence once this happens.

 

While the menopausal stage in a woman’s life may be considered an inevitable, this does not mean that one has to live with these disorders. There are many things a woman may do to prevent or manage these conditions without undergoing invasive treatments, as proven by clinical trials. In addressing these problems, behavioral and lifestyle changes have been shown to be very effective, even allowing women to maintain a positive quality of life.

 

With these conservative measures, it is hoped that a woman suffering from POP or SUI may not have to undergo a surgical procedure for treatment. In light of the controversy surrounding vaginal mesh surgeries, this surgical option may only put unnecessary risks to women. These procedures, which have become very common recommendations among doctors, have caused severe complications resulting to serious injuries.

 

This pain and suffering experienced by these victims have compelled them to take legal remedies such as filing of vaginal mesh lawsuits. Lawsuits have already been scheduled with some already decided by juries, with one case in the news lately with the upholding of the $2 million verdict given by the jury.

 

References:

continence.org.au

nursingtimes.net

Risk Of Surgery For POP, SUI Jumps From 11% To 20%

Sunday, November 24th, 2013

By the time a woman reaches 80 years of age, the lifetime risk of having a surgery for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) repair will almost be doubled to 20 percent, based on the results of a study which was presented to the American Urogynecologic Society during its regular scientific meeting. For those suffering from these conditions, the risk of surgery had been estimated at only 11 percent for over two decades and perhaps in millions of publications on pelvic floor disorders.

 

Undertaken by a team led by Dr. Jennifer Wu of the University of North Carolina, this study was based on data using population-based MarketScan databases for the period 2007 to 2011. From the claims of 51.8 million privately insured women, the team was able to identify 311,070 surgeries involving POP and SUI repairs performed during the period.

 

Analysis of the data showed that by the age of 80 years, a woman’s lifetime risk for SUI surgery is 14.5 percent and 13.7 percent for POP. The combined risk for either surgery was placed at 16 percent at age 70 years and to increase to 20 percent by the time the woman reaches 80 years of age.

 

These new figures may bring about a number of significant implications which have caused grave concerns to the medical world. It is worth noting that in the coming years, the actual number of women requiring surgery may actually be more than double since the women who will be growing older represent a very large portion of the population.

 

With more women requiring medical services, the need for more healthcare providers specializing in this field becomes very pressing. In meeting the needs of these women, there might not be enough doctors, at the present rate of new surgeons learning this sub-specialty. This raises also the vital need for research and education directed at effectively addressing this problem which may become epidemic in proportion.

 

The very important issue of the method of surgery in treating these pelvic floor disorders may be raised anew, particularly the use of the very controversial surgical mesh. In the absence of any order discontinuing the use of these pelvic implants in the repair of pelvic floor disorders and with a large number of surgeons advocating the use of these devices; it might not be farfetched for the vaginal mesh problem to drag on.

 

While the debate on the merits of using vaginal mesh devices rages on even among doctors, numerous surgeons continue to use these devices in treating their patients. Even with the guidelines set by the Food and Drug Administration (FDA) on using surgical mesh, patients will always put their unwavering trust on their attending physicians.

 

That the new crop of vaginal mesh devices will be rigorously tested for its safety and efficacy may be argued by mesh manufacturers, but events in the recent past cannot be ignored easily. A big number of women have suffered serious injuries from these devices which experts have labeled as defective. Legal actions such as vaginal mesh lawsuits against mesh manufacturers have been resorted to by these victims.

 

 

References:

medscape.com

iuga.org

Reports Of Terrible Complications Prompt Actions Against Vaginal Mesh Surgery

Monday, November 18th, 2013

The Scottish Minister of Health and Wellbeing, according to articles released in several online media sources, have taken concrete steps against vaginal mesh surgery after receiving reports of terrible complications endured by thousands of women. These complications have led to serious injuries that have prompted women to take legal actions against manufacturers of these mesh products. At least six mesh implant companies have been named defendants in a multidistrict litigation (MDL) in West Virginia with court proceedings already set by the court including that of Boston Scientific which has been scheduled for next year.

 

While no vaginal mesh lawsuits have been heard before the courts in Scotland, this issue recently gained great prominence after reports were published describing the ordeals of women who had been implanted with these mesh devices. As a result, Mr. Alex Neil, the Minister of Health and Wellbeing, ordered the National Health Service to take the necessary steps in addressing this important issue.

 

The Agency’s initial action consisted of the production of revised consent forms and information leaflets which would be made available within two weeks. Women who were planning to undergo pelvic surgery using these mesh implants were to given these leaflets. Consent forms will also be revised which will be designed to make both the patient and attending physician aware of all the risks involved and other vital information relating to the surgical procedure.

 

The establishment of an implant register which will put into record all surgeries involving medical devices such as polypropylene mesh implants, breast implants, and hip replacement was also recommended by concerned sectors. This was a timely suggestion in light of the recent controversy involving the breast implant scandal that shocked the European Union.

 

In the efforts of anti-mesh campaigners to advance their cause, they have asked the assistance of a well-known surgeon from the United States who has been very vocal in his stand against vaginal mesh surgeries. Dr. Michael Thomas Margolis of the Bay Area Pelvic Surgery highlighted the dangers of using mesh implants through a letter sent to Minister Alex Neil.

 

In the letter, Dr. Margolis stated that he had been removing mesh since its introduction and had performed removal surgeries more than 200 times. His experiences in treating women suffering from complication which have resulted to injuries to the bladder, bowel, blood vessels, and the vagina were relayed in his letter. He also mentioned treating patients who were experiencing vaginal mesh erosion, chronic infection, scarring, chronic pain, morbid disfigurement, and loss of function of the vagina.

 

His letter to the minister also included his observation that marriages have disintegrated as a result of loss of consortium due to the damage caused by the mesh on the woman’s sexual organ. He also indicated that most importantly, there are traditional surgical procedures which have shown to be effective and may even be superior compared to the use of vaginal mesh devices in treating pelvic organ prolapse and incontinence.

 

References:

meshmedicaldevicenewsdesk.com

 

theparliament.com