Posts Tagged ‘Maine’
The Vaginal Mesh Helpline receives calls from women on a daily basis regarding their vaginal mesh complications. many have urinary tract infections which is one of the reported side effects of a vaginal Mesh implant. Below is an overview of urinary tract Infections
Most urinary tract infections are not serious and can be easily treated with antibiotic medications. However urinary tract infections from a Vaginal mesh implant can become chronic. The symptoms of a urinary tract infection can be stubborn with a vaginal mesh and can persist after treatment. Many reported Infections are recurring and come back just a few weeks after treatment. Nearly 20 percent of women who have a urinary tract infection will have another, and 30 percent of those who have had two will have a third. About 80 percent of those who have had three will have a fourth. If left untreated, urinary tract infections can lead to other more complicated health problems so they should not be ignored.
How the Urinary Tract Works
Your urinary tract includes two kidneys, two ureters, the bladder and the urethra. Your kidneys remove waste and water from your blood to produce urine. Urine travels through muscular tubes, called the ureters, to the bladder. The bladder is a balloon-like organ composed of muscle, connective tissue and nerves that swells as it fills with urine. Urine is stored in the bladder until it is released from the body through another tube, called the urethra. Two muscle groups, the pelvic floor muscles and the urinary sphincters, control the activity of the urethra and bladder neck. These muscles must work together to hold urine in the bladder most of the time and allow the bladder to empty when appropriate.
Cause of Urinary Tract Infection: Bacteria, Potentially from Mesh Erosion and Scar tissue
Most urinary tract infections are caused by a variety of bacteria, including Escherichia coli (E. coli), found in feces. Because the openings of the bowel, vagina and urethra are very close together, it's easy for the bacteria to spread to the urethra and travel up the urinary tract into the bladder and sometimes up to the kidneys.
Untreated Urinary Tract Infections: Bladder & Kidney Infections—Important
Infection occurs when the bacteria cling to the opening of the urethra and multiply, producing an infection of the urethra, called urethritis. The bacteria often spread up to the bladder, causing a bladder infection, called cystitis. Untreated, the infection can continue spreading up the urinary tract, causing infection in the kidneys, called pyelonephritis. Pyelonephritis can also occur without a preceding bladder infection. A kidney infection that is not treated can result in the bacteria entering the bloodstream (this is known as urosepsis), which can be a life-threatening infection requiring hospitalization and intravenous antibiotics.
The first sign of a bladder infection may be a strong urge to urinate or a painful burning sensation when you urinate. You may feel the urge to go frequently, with little urine eliminated each time. The urge to urinate again returns quickly, and urination may be hard to control. You may have urinary leakage. You may also have soreness in your lower abdomen, in your back or in the sides of your body. Your urine may look cloudy or have a reddish tinge from blood. It may smell foul or strong. You also may feel tired, shaky and washed out. If the infection has spread to the kidneys, you may have fever, chills, nausea, vomiting and back pain, in addition to the frequent urge to urinate and painful urination.
Common Causes of UTIs, However UtIs have been reported side effects form vaginal mesh implants
Some women are more prone to urinary tract infections than others because the cells in their vaginal areas and in their urethras are more easily invaded by bacteria. Women with mothers or sisters who have recurring urinary tract infections also tend to be more susceptible. Your risk of urinary tract infection also is greater if you're past menopause. Thinning of the tissues of the vagina, bladder and urethra, as well as change in the vaginal environment after menopause, may make these areas less resistant to bacteria and cause more frequent urinary tract infections.
Irritation or injury to the vagina or urethra caused by sexual intercourse, douching, tampons or feminine deodorants can give bacteria a chance to invade. Using a diaphragm can cause irritation and can interfere with the bladder's ability to empty, giving bacteria a place to grow.
Any abnormality of the urinary tract that blocks the flow of urine, such as a kidney stone or significant prolapse of the uterus or vagina, also can lead to an infection or recurrent infections. Illnesses that affect the immune system, such as diabetes, AIDS and chronic kidney diseases, increase the risk of urinary tract infections. A weak bladder can also make it difficult to empty completely, allowing bacteria to grow. Lengthy use of an indwelling catheter, a soft tube inserted through the urethra into the bladder to drain urine, is a common source of urinary tract infections. Intermittent catheterization (where a person empties the bladder several times a day but the catheter is removed immediately) actually is used to prevent recurrent infections in some patients.
Because the uterus sits directly on the bladder during pregnancy and can block the drainage of urine from the bladder, UTIs are more common in pregnant women. And when women develop urinary tract infections during pregnancy, the bacteria are more likely to affect the kidneys. Hormonal changes and repositioning of the urinary tract during pregnancy may make it easier for bacteria to invade the kidneys. Such infections in pregnant women can lead to urosepsis, kidney damage, high blood pressure and premature delivery of the baby. All pregnant women should have their urine tested periodically during pregnancy. Pregnant women with a history of frequent urinary tract infections should have their urine tested often. Most antibiotic medications are safe to take during pregnancy, but your health care professional will consider the drug's effectiveness, how far your pregnancy has progressed and the potential side effects on the fetus when determining which medication is right for you and how long you should take it. If you have a vaginal mesh and are showing signs of chronic infection we advise you to see a Urogynecologist immedicately. Vaginal mesh helpline Lawyers are accepting clients with transvaginal mesh complications.
Vaginal Mesh Helpline Announces the Bard and Johnson and Johnson Vaginal mesh Multi District litigation has been consolidated in New Jersey. Vaginal Mesh Helpline Lawyers are filing lawsuits in new Jersey for women injured by the Bard and J&J vaginal mesh implants.
C.R. Bard products lawsuits consolidated in New Jersey
Bard Pelvilace or Pelvicol
Bard Uretex TO
Bard Uretex TOO2
Bard Uretex TOO3
Gynecare / Ethicon / Johnson & Johnson products
Gynecare TVT Exact
Gynecare TVT Abbrevo
Gynecare TVT Retropubic System
Gynecare TVT Obturator
Gynecare TVT Secur
Gynecare Gynemesh PS
Three multidistrict litigations involving the risks of transvaginal mesh were consolidated this past week into a single MDL before Chief Judge Joseph R. Goodwin the U.S. District Court for the Southern District of West Virginia. The MDLs were filed against Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc.
Judge Goodwin was already handling another MDL involving Avaulta transvaginal mesh against C.R. Bard. Consolidating so many similar MDLs before one judge is very unusual. However it will benefit our clients to have a streamlined process overseen by the same judge, regardless of which company manufactured their defective TVM implant.
The Vaginal Mesh Helpline hears from women on a daily basis regarding their mesh complications
- Vaginal Pains and Bleeding
- Vaginal infections
- patch bleeding
- painful intercourse
- lower back pain
- trouble voiding or urinary incontinence
- Vaginal extrusion of the surgical mesh, and
- bladder and bowel erosion
The Boston Scientific Vaginal Mesh Lawsuits have been Consolidated in Massachusetts.
The vaginal mesh lawsuits are multi District litigations. That means that the lawsuits against one manufacturer are consolidated in one courtroom in the country. The Boston Scientific Mesh has been consolidated in Massachusetts. The Vaginal Mesh Helpline Lawyers will be filing suit for women injured by the Boston Scientific Mesh in Massachusetts.
Boston Scientific Transvaginal Mesh and Sling Products Include:
- Pinnacle Pelvic Floor Repair Kits: Used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
- Uphold Vaginal Support system: Used to treat pelvic organ prolapse (POP).
- Advantage Fit Sling System: Used to treat stress urinary incontinence (SUI).
- Obtryx Sling System: Used to treat stress urinary incontinence (SUI).
- Prefyx Sling System: Used to treat stress urinary incontinence (SUI).
- Solyx SIS System: Used to treat stress urinary incontinence (SUI).
- Lynx Sling System: Used to treat stress urinary incontinence (SUI).
Complications reported to the Vaginal Mesh Helpline Include:
- Mesh erosion through the vaginal wall bladder or bowel
- Mesh extrusion and exposure
- Perforation or puncture of bladder, intestines, bowels, and/or vaginal wall
- Protusion or lump in the vaginal opening
- Chronic Infection
- patch bleeding
- pain on one side of the body
- difficulty in passing urine or urinary incontinence
- feeling of discomfort and muscle tightening
- Recurrence of Pelvic Organ Prolapse (POP)
- Recurrence of Stress Urinary Incontinence (SUI)
- lower back pain
- Vaginal bleeding
- Painful sexual intercourse
Women who experience Boston Scientific transvaginal mesh complications have attempted to locate a doctor tp have their mesh removed . The vaginal mesh Helpline reports women having numerous surgeries to remove the mesh.
Boston Scientific Pinnacle Pelvic Floor Repair Kit Recall
In August 2011, Boston Scientific issued a Class 2 recall for about 540 Pinnacle Pelvic Floor Repair Kits. According to the recall notice, manufacturing problems had resulted in some products exhibiting a low tensile strength between the needle and suture. This could cause needle detachment during mesh leg placement.
If you are having complications from a Boston Scientific vaginal Mesh contact the vaginal Mesh Helpline today.
The Vaginal mesh helpline gets calls from women daily who are being told by their doctors nothing is wrong. The symptoms are usually similiar. They have severe pain and cannot function, Their incontinence is back worse or the cannot void, They have lower back pain, they cannot have sexual intercourse, they are having patch bleeding, and other types of bladder and bowel problems. While doctors are looking for tumors, lower back problems and medications to calm them down psychologically they call the Vaginal Mesh Helpline worried an upset.
What do they all have in common? Some kind of vaginal mesh product that is "ruining their lives". The mesh was usually put in by a gynecologist or urologist. The reason was anything from severe prolapse to simple SUI. Doctors believed the answer to every single female problem was the mesh. This was the new miracle cure. Women went in for a hysterectomy and came out with a mesh. But, it just is not playing out that way. Mny women did not seem to even realize a mesh was being used until the turn on their T.V set and see the symptoms in the layer Ads.
Our vaginal mesh callers are feeling like their lives are over. They are in pain, distraught, angry and losing their marriages, boyfiriends and fiances over this " Miracle Mesh". Women are losing their jobs and cannit work. School bus drivers cannot drive a bus any longer due to the severe pain.
Many of these women were lead so astray by their doctors that hey are only first realizing their complications are the mesh when they see a lawyer ad on T.V. "look , a family member says, this is you". "You need to look into this right away"
They call the helpline. Or maybe they just got an email blast from a leads company or lawyer. The advertising for the mesh is waking women up to what is really going on inside their body.
Very few can go back to the doctor that put the mesh in. Doctors are to frightened right now to give good medical care. They are worried about the consequences of what they did. Many are telling women that they are fine. "It is all in your head"' There is nothing wrong here"
They attempt to cut of the "Bad Part". We had a women caller whose Doctor tried to pull the piece out. What can a woman do ?
We suggest the call the association of Urogynecologists for a local Urogynecologist. We also suggest they locat a local University Hospital Department of Urogynecology. "You must ask for a Doctor who has experience in mesh removal". "That way you will know that they understand there is problems with the mesh".
What else can women do? They must get on the list for the Mult District litigation with a lawyer who has experience with mass torts.
They must be alerted to leads companies that are soliciting to sell them to lawyers. It is not in your head. You are not alone and you must seek medical advise. These mesh implants can cause very serious complications and hut the internal organs. Bowel Bladder and vaginal erosion is a potentail result. Mesh Erosion into the bowel or bladder can be very serious.
In 2011, the FDA published new guidelines regarding manufacturer requirements for pelvic mesh. Since the institution of such guidelines, Boston Scientific represents the first company to received FDA approval for a new pelvic mesh. We do not know ,nor do many of the women calling, what mesh they have. We do not know if this knew mesh is one of the ones creating problems in 2012. What we do knoe is an estimated 300,000 women have these mesh implants and are suffering.
Harris-Hicks, who practices at Sandhills Gynecology of Sandhills Regional Medical Center, has 12 years of experience in POP surgery. She received her training at Greenville Memorial Hospital in Greenville, S.C.
“POP and urinary incontinence are common conditions affecting many adult women today,” said Harris-Hicks. Pelvic organ prolapse is the abnormal descent or herniation of the pelvic organs including the bladder or rectum from their normal position inside the pelvis. Severe POP results in complete extrusion of the vagina outside of the pelvic floor.
Read more: Richmond County Daily Journal – Sandhills Gynecology physician among top surgeons to use new product for leaky bladders
Risks with Cystocele and Rectocele Mesh Repair, FDA Warnings, Vaginal mesh lawyers
In July 2011, the FDA released a safety communication warning healthcare providers of the serious risks associated with surgical mesh used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Specifically, the FDA stated that complications were not rare, and that surgery with the mesh may be no better than traditional surgery options that don’t use mesh.
Public Citizen and Vaginal mesh
In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. They stressed that there is a need for these non-absorbable vaginal meshes to be removed from the market since it’s benefits over other non-mesh procedures used to repair POP and SUI were unseen, and patients who received them developed fatal reactions. The group also recommends that all non-absorbable vaginal mesh be tested appropriately for safety and effectiveness before the FDA approves its availability in the market.
FDA 510 (K) Process
Manufacturers needed only to show they were similar to devices already on the market to gain approval through the FDA’s 510(k) approval process. The remaining eight recalled devices didn’t have to go through any kind of FDA review. Of the 113 recalls, 35 were for cardiovascular devices, including automated external defibrillators, or AEDs, and only 12 of them had been required to undergo patient testing.
POP repair surgeries may include cystocele and rectocele.
Unfortunately, complications have been found with both.
Types of POP Repair Include Cystocele and Rectocele.The sling procedure, or suburethral sling procedure, refers to a particular kind of surgery using ancillary material to aid in closure of the urethral sphincter function of the bladder. It is performed as a treatment of severe urinary incontinence. The sling procedure, also known as the suburethral fascial sling or the pubovaginal sling, has many forms due to advances in the types of material used for the sling. Some popular types of sling material are Teflon (polytetrafluoroethylene), Gore-Tex ® , and rectus fascia (fibrous tissue of the rectum).
Cystocele and rectocele repair
- Cystocele—bladder prolapse
- Rectocele—rectal prolapse (end of the large intestine, or rectum)
- Uterine prolapse
- Vaginal prolapse
- Enterocele—herniated small bowel
Rectocele or Enterocele
A rectocele camera occurs when the end of the large intestine (rectum) pushes against and moves the back wall of the vagina. An enterocele (small bowel prolapse) occurs when the small bowel camera presses against and moves the upper wall of the vagina. Rectoceles and enteroceles develop if the lower pelvic muscles become damaged by labor, childbirth, or a previous pelvic surgery or when the muscles are weakened by aging.
rectocele mesh repair complications
- Painful Intercourse
- Shortened Vagina
- Vaginal Scar Tissue
- Rejection of Graft
- Vaginal Wound Dehiscence
- Mesh extrusion or erosion
Mesh was initially incorporated into POP surgical repair because it offered more support to the affected organ and helped shore up surrounding muscles and tissues. Since the risk for recurrence of prolapse is high in women who have cystocele surgery and rectocele surgery, the hope was that surgical mesh would help sustain the repair. The FDA received many reports, however, or cystocele mesh complications and rectocele mesh complications.
The Vaginal Mesh Mess
Women are suffering from the vaginal mesh repair.
Other Vaginal Mesh repair complications
- erosion of mesh
- serious infection
- recurrence of pop / sui
- corrective surgeries
- injury to other organs
- vaginal scarring
- urinary problems
- hardening of mesh
Cystocele Mesh Complications and Rectocele Mesh Complications
During cystocele surgery, transvaginal mesh is inserted through the vagina to help act as a barrier and to hold the bladder in place. The mesh is also intended to help stop related problems like incontinence.
A rectocele occurs when the thin wall of tissue separating the rectum from the vagina weakens, allowing the front of the rectum to bulge into the vagina. During rectocele surgery, excess stretched tissue is removed through the vagina, and a mesh patch may be used to support and strengthen the wall. (Surgery may also proceed from the abdomen, anus, or perineum.)
Though surgical mesh does seem to provide better support for pelvic organs, cystocele mesh complications and rectocele mesh complications made the improvement a moot point. The FDA, in its 2011 warning, mentioned that it had received nearly 3,000 reports of vaginal mesh complications between 2008 and 2010, with the most common being mesh erosion through the vagina. Mesh erosion can require multiple surgeries to repair and may be extremely debilitating.
Other cystocele mesh complications and rectocele mesh complications included pain, infection, bleeding, pain during sex, organ perforation, urinary problems, recurrent prolapse, vaginal scarring/shrinkage, and neuro-muscular problems. Many required additional surgical treatment and hospitalization.
Cystocele Surgery and Rectocele Surgery
Cystocele, urethrocele, enterocele, and rectocele are particularly likely to occur together. Urethrocele is virtually always accompanied by cystocele (cystourethrocele). Cystocele and cystourethrocele commonly develop when the pubocervical vesical fascia is weakened. Enterocele usually occurs after a hysterectomy. Weakness in the pubocervical fascia and rectovaginal fascia allows the apex of the vagina, which contains the peritoneum and small bowel, to descend. Rectocele results from disruption of the levator ani muscles.
Severity of these disorders can be graded based on level of protrusion:
- 1st degree: To the upper vagina
- 2nd degree: To the introitus
- 3rd degree: External to the introitus
If you have been injured due to a vaginal mesh from any of the manufactuirers listed below contact Vaginal mesh Helpline 1 877 522-2123
Johnson & Johnson
- Ethicon TVT
- Gynecare Prolift
- Gynecare Prosima
- Gynecare TVT
- Gynemesh PS
- Avaulta PlusT BioSynthetic Support
- Avaulta SoloT Synthetic Support
- Faslata Allograft
- PelvitexT Polypropylene Mesh
- Pelvicol Tissue
- PelviSoft Biomesh
- AdvantageT Sling System
- Prefyx Mid UT Mesh Sling System
- Prefyx PPST System
- Obtryx Curved Single
- ObtryxMesh Sling
American Medical Systems
Cystocele Mesh Repair has lead to Complications, Vaginal mesh helpline Offers Support and Guidance
What is a Cystocele ?
Cystocele is the name of a disorder in women in which the muscles and tissues between the bladder and the vagina stretch and weaken, causing the bladder to drop or prolapse into the vagina. hernia in which the urinary bladder protrudes through the wall of the vagina; sometimes occurs after childbirth. Cystocele is often called “fallen bladder.” Other names include cystocele prolapse and cystocele bladder prolapse.
A bladder that has dropped from its normal position may cause two kinds of problems-unwanted urine leakage and incomplete emptying of the bladder. In some women, a fallen bladder stretches the opening into the urethra, causing urine leakage when the woman coughs, sneezes, laughs, or moves in any way that puts pressure on the bladder.
A cystocele is mild-grade 1-when the bladder droops only a short way into the vagina. With a more severe-grade 2-cystocele, the bladder sinks far enough to reach the opening of the vagina. The most advanced-grade 3-cystocele occurs when the bladder bulges out through the opening of the vagina.
Repair of Bladder Prolapse (Cystocele) or Urethra Prolapse (urethrocele)
Two common forms of pelvic organ prolapse are bladder prolapse (cystocele) and urethral prolapse (urethrocele). A cystocele occurs when the wall of the bladder presses against and moves the wall of the vagina. A urethrocele occurs when the tissues surrounding the urethra sag downward into the vagina. Both conditions are easy for your doctor to see during a physical exam. They often occur at the same time and are usually caused by damage that happens when a baby is delivered through the mother's birth canal (vagina)
What causes a Cystocele ?
Most common causes
Pregnancy and vaginal childbirth are the most common causes of a cystocele. Women who have only cesarean section deliveries are less likely to develop prolapse.
Prolapse may also be caused by straining your pelvic floor muscles through:
- Being overweight or obese
- Repeated heavy lifting
- Straining with bowel movements
- A chronic cough or bronchitis
Symptoms that Result.
Once the bladder has dropped from its normal position, it can cause symptoms like urine leakage, incomplete emptying of the bladder, and stress urinary incontinence (SUI—urine leakage that occurs when a woman coughs, sneezes, or laughs). The severity of the symptoms depends on the severity of the cystocele:
Grade 1 (mild): the bladder drops only a short way into the vagina
Grade 2 (moderate): the bladder reaches the opening of the vagina
Grade 3(severe): the bladder bulges through the opening of the vagina
Treatment for Cystocele Prolapse
Treatment for cystocele depends on the severity of the condition. Women with mild cystocele may be able to manage it simply by avoiding heavy lifting and straining. If symptoms are moderately bothersome, a doctor may recommend a pessary, which is a removable device placed in the vagina to help keep the bladder in place. Estrogen therapy may also help strengthen the muscles around the bladder.
For severe cases of cystocele, surgery may be required to move the bladder back into a normal position and keep it there. Traditional surgeries simply stitched the muscles and connective tissues together to hold the bladder, but this surgery was prone to relapse. Cystocele mesh repair seemed like a better option, until women started experiencing serious complications.
Cystocele Mesh Repair May Cause Complications
In cystocele mesh repair, a surgeon uses a synthetic surgical netting to help support and secure the bladder back in place, and to lend strength to surrounding muscles and tissues. Studies have shown that this repair typically lasts longer, as far as keeping the bladder in place, but unfortunately, it can cause more complications, which may include:
- Pelvic pain
- erosion into the bladder or bowel
- bowel incontinence
- Mesh extrusion
- Painful intercourse
- Cystocele bladder prolapse recurrence
- Vaginal scarring and mesh erosion
FDA Warning About Cystocele Mesh Repair
In addition to the July 2011 FDA warning about the risks of complications with vaginal mesh repair, the agency also scheduled a subcommittee meeting to further evaluate the safety issues. The mesh was pushed thru on the FDA fast track wothout additional testing. The consensus from that meeting was that the safety of vaginal mesh is not well established, and more clinical studies need to be done on the currently available products.
Call the Vaginal mesh helpline to speak to a female medical social worker and a cystocele mesh lawyer.
Speak to a female medical Social Worker with over 20 years experience in dealing with Doctors and lawyers At the Vaginal Mesh Helpline Today.
What is Urogynecology?
Urogynecology is the treatment of female pelvic floor disorders. The term “pelvic floor” refers to the group of muscles that form a sling or hammock across the opening of a woman’s pelvis. These muscles, together with their surrounding tissues, keep all of the pelvic organs in place so that the organs can function correctly. A Urogynecologist usually will be familiar with your vaginal mesh and the complications.
A pelvic floor disorder occurs when the pelvic muscles and connective tissue in the pelvis weaken or are injured. An estimated one-third of all U.S. women are affected by one type of pelvic floor disorder in her lifetime. Over 300,000 women were implanted with some kind of vaginal mesh or bladder sling device.
These disorders may involve pelvic organ prolapse and difficulties with bladder and bowel control. Women often describe prolapse as a vaginal bulge. Bladder problems include urinary frequency – including nighttime frequency and incontinence. Bowel problems may include constipation and fecal incontinence. Because these problems often occur together, evaluating the entire pelvis gives us a more complete picture of the problem. Many women were implanted with vaginal meshes to resolve these problems. However "the miracle cure" turned into a horror story for many women. The vaginal mesh helpline speaks to women on a daily basis who have vaginal mesh Complications.
FDA ON UROGYNECOLOGY
Urogynecologic Surgical Mesh Implants
Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material.
Surgical mesh can be used for urogynecologic 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.
Based on an updated analysis of adverse events reported to the FDA and complications described in recent scientific literature, on July 13, 2011 an FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse was issued to inform the medical community and patients that:
serious complications associated with surgical mesh for transvaginal repair of POP are not rare
it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair
The FDA continues to evaluate the effects of using surgical mesh for treatment of urine leakage during moments of physical activity (stress urinary incontinence) and will provide updates on this webpage at a later date.
On this webpage, the FDA provides information about the use of surgical mesh placed transvaginally for the treatment of POP, recommendations for health care providers and women to help reduce risks, and steps to report problems to the FDA. The information provided on this webpage is not meant to replace a discussion with your health care provider.
American Urogynecologic Society
2025 M Street NW, Suite 800
Washington, DC 20036
P: 202.367.1167 | F: 202.367.2167
Support the AUGS Foundation
International Urogynecology Association
IUGA Office | 790 East Broward Blvd. Suite 300 | Fort Lauderdale, FL 33301 | USA | firstname.lastname@example.org
Call the Vaginal mesh helpline and speak to a female social worker and get connected the a transvaginal mesh lawyer
Vaginal mesh lawyers of Vaginal Mesh Helpline are filing lawsuits for faulty vaginal mesh. Women are seeking justice for the suffering they have endured form the vaginal mesh.
J&J Picks Gorsky as Next CEO to Find Stability After Recalls
February 22, 2012, 2:29 PM EST
Feb. 22 (Bloomberg) — Johnson & Johnson’s insider pick of Alex Gorsky as the new chief executive officer elevates the person most familiar with the safety and quality issues that have plagued the company.
Gorsky, 51, a former army captain and endurance athlete, now leads the devices and supply-chain units. He will be seen by investors as a force for stability at a time when J&J’s image has been tarnished by recalls of artificial hip implants and over-the-counter drugs, and safety concerns involving vaginal mesh products that have spurred thousands of lawsuits.
“We do not anticipate significant changes in J&J’s strategic direction under his leadership,” Lawrence Biegelsen, an analyst at Wells Fargo Securities in New York, wrote in a research note after the move was announced.
Gorsky, who has spent all but four of the last 24 years at J&J, succeeds outgoing CEO William C. Weldon, 63, who will stay on as chairman. J&J was almost certain to go with an internal candidate after Weldon set up a succession race in 2010 between Gorsky and another top executive, Sheri S. McCoy, 53, the leader of the company’s branded-drug units.
The executives weren’t available for interviews, William Price, a J&J spokesman, said in an e-mailed statement.
The change comes during a difficult month for J&J, the world’s second-biggest seller of health-care products.
On Feb. 13, the New Brunswick, New Jersey-based company was knocked from one of the top two spots in Harris Interactive’s annual consumer poll of corporate images for the first time in 13 years, falling to seventh. On Feb. 17, the drugmaker said it was recalling more than half-million bottles of infants’ Tylenol, because of complaints with the dosing system.
J&J gained less than a percent to $65.14 at 1:48 p.m. New York time. The stock had gained 6.4 percent in the past 12 months, which ranks eighth of the 12 companies in the Standard & Poor’s 500 Pharmaceutical Index.
The recall was the latest of hundreds of millions of packets of Tylenol, Motrin, Benadryl and other products pulled due to foul odors, adulterated ingredients and bad labeling over two years, part of drumbeat of revelations that have undermined the company’s reputation for quality and safety.
“Gorsky is a conservative choice and the strongest internal candidate,” said Erik Gordon, a business professor at the University of Michigan, in Ann Arbor. “That’s a big deal at a company that always taps an insider as its next CEO — even if what they need is someone from outside the team that led the company into so much trouble.”
Gorsky, a graduate of the U.S. Military Academy at West Point, will take over April 26 at the company’s annual meeting as only the ninth leader in J&J’s 126-year history, the company said yesterday in a statement. In an October 2011 speech to fellow military veterans in Chicago, Gorsky offered lessons on making business decisions that he said he learned during his career.
“You don’t have to get it 100 percent right,” Gorsky said in a talk posted online by MBA Veterans, which hosted the conference. “When you get it 60 percent, go! Any more time that you spend trying to figure it out, you’re going to lose in the speed that you’re missing out on.”
Gorsky also described himself as someone who leads by listening before he talks.
“That allows you to collect much more meaningful input and ultimately make the right call,” he said in an online video discussing his education experiences at the University of Pennsylvania’s Wharton School of Business in Philadelphia, where he received his MBA in 1996.
J&J, maker of everything from Band-Aids to cancer drugs, generated $65 billion in 2011 sales. While Gorsky takes over a company that has seen a revival in its drug business, the device unit he ran faces lawsuits over the recalled artificial hips and vaginal mesh implants.
“It’s been a challenging time for devices, but not through any of Alex’s doing,” said Rick Wise, a Leerink Swann & Co. analyst in New York, by telephone. Gorsky is “a thoughtful, disciplined, capable guy” who should steer J&J well, he said.
J&J’s DePuy unit faces more than 4,500 lawsuits over its ASR hips, which the company recalled in August 2010. At the time, The company recalled 93,000 hips worldwide, including 37,000 in the U.S., saying that more than 12 percent failed within five years.
One lawyer suing the company, Michael A. Kelly, said he was “shocked” that J&J elevated Gorsky.
“It’s clear that the medical device division was not being well supervised, managed or run, certainly from 2006 through 2010, when the entire ASR debacle was going forward,” said Kelly, of Walkup, Melodia, Kelly & Schoenberger in San Francisco.
“I would think somebody would say: At what cost are we making the profits and what message does it send that we promote the person who was in charge of this division to an even higher job, given the way that the entire ASR issue was handled,” Kelly said.
Gorsky, a former marathon runner, joined J&J’s Janssen Pharmaceutica unit in 1988 as a sales representative, according to a company biography. He then left the company in 2004 to join Basel, Switzerland-based Novartis AG, where he headed North American pharmaceuticals.
$1.2 Million Pay
Four years later, he returned to J&J, and he was named global chairman of the devices and diagnostics groups in 2009. He’ll be paid $1.2 million as CEO, the company said in a filing.
Weldon, in an e-mailed statement, described Gorsky as “an experienced, visionary and disciplined leader with more than 20 years of increased and broad-based responsibilities over two separate periods of employment with Johnson & Johnson.”
Jeff Jonas, an analyst with Gabelli & Co. in Rye, New York, called Gorsky “the natural choice. I don’t think there’s going to be a huge change; he’s been involved in a lot of their recent decisions anyway,” he said in a telephone interview.
Since Weldon took over as CEO on April 15, 2002, the shares have increased an annual 2.8 percent, according to data compiled by Bloomberg. During his tenure, Weldon pulled off the two biggest deals in company history: the $16.6 billion purchase of Pfizer’s consumer products in 2006 and last year’s agreement to buy orthopedics maker Synthes Inc. for $21.3 billion. The latter is pending regulatory reviews.
J&J sales may increase to $66.4 billion this year, Biegelsen, the Wells Fargo analyst, predicted in a Jan. 25 note to clients. That includes $26.2 billion in device revenue, $25 billion from the drug unit and $15.2 billion from the consumer division. New York-based Pfizer Inc. is the world’s biggest seller of medical products.
McCoy, Gorsky’s competitor for the top spot, will continue in her role as head of the pharmaceutical and consumer group, J&J said yesterday in its statement.
According to the vaginal mesh helpline Johnson and Johnson is one of the leading manufacturers of vaginal mesh implant products. Call come in on a daily basis from women suffering with complications.
CR Bard sued over mesh product
2/15/2012 8:42 PM By Kelly Holleran
A woman has filed suit against the manufacturer of a mesh product that she claims eroded her vaginal lining, causing her to endure multiple surgeries.
Mary Ann McCloskey claims doctors inserted a Bard pelvi soft acellular collagen biomesh into her during a surgical procedure in November 2006. The mesh was manufactured by defendant C.R. Bard, according to the complaint filed Jan. 30 in St. Clair County Circuit Court.
The mesh, however, failed to function as it should have and eroded Mary Ann McCloskey's vaginal lining, the suit states.
It was not until Feb. 25, 2010, that Mary Ann McCloskey discovered her injuries were a result of the mesh, according to the complaint.
Because of the mesh, Mary Ann McCloskey suffered internal bleeding, experienced pain, endured multiple surgeries and sustained constant suffering, the complaint says. In addition, she claims she lost her normal life, incurred medical costs and suffered an impairment to her earning capacity.
Due to his wife's injuries, William McCloskey claims he lost her consortium.
Women are claiming that transvaginal mesh complications made intimate relations impossible with their spouse or significant other. Many women have reported that the feeling of pain and discomfort has been so severe that it has prevented them from engaging in normal sexual activity.
Many spouses and significant others of women have been filing a loss of consortium claim. Loss of consortium occurs when one partner is no longer able to fulfill their sexual role or otherwise provide the companionship, love and affection they were able to before their injury occurred. Husbands believe they have grounds for a consortium lawsuit cand are seeking monetary damages from the manufacturers they believe was responsible for their spouse’s injuries.