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Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. FDA Tightens Restrictions On Vaginal Mesh

   Jan 11, 2016 | Immortal News

   By Mary Walsh
   
   
   This new classification comes after over 100,000 lawsuits have been filed against the companies who make these products, including Boston Scientific Corp, C.R. Bard, Johnson & Johnson, and Endo International PLC.
2. Pelvic prolapse: What you need to know about this common health issue

   Jan 12, 2016 | Starts at Sixty

   Many women suffer from prolapse of the uterus, known as vaginal or pelvic organ prolapse. While it can be an embarrassing and uncomfortable issue, you should not ignore it, and you certainly don’t have to deal with it alone.

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. FDA Tightens Restrictions On Vaginal Mesh

   Jan 11, 2016 | Immortal News

   By Mary Walsh

   On Monday, the Food and Drug Administration announced that it was tightening restrictions for a product used to repair Pelvic Organ Prolapse (POP). The product, a vaginal mesh, has been linked to multiple reports of harmful side effects, such as nerve damage and bleeding.

   POP happens when the walls of the uterus or vagina weken, stretch, or tear, usually after childbirth, and can no longer support the internal organs, which protrude into the vagina, creating an uncomfortable feeling.

   The surgical mesh will be reclassified as a device from class II, moderate risk, to a device from class III, high-risk. While the FDA is reclassifying this surgical mesh for use with POP, the agency is not applying this new classification to other indications, such as stress urinary incontinence or abdominal repair. These devices have been in use since the middle of the 20th century, when surgeons used them to repair abdominal hernias.

   The mesh kits were made available through an expedited review in which the makers only need to prove that the product is substantially similar to ones already being sold. Manufacturers that have products on the market have two and a half years to comply with new the data requirements, including data on the safety and effectiveness.

   These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.

   This new classification comes after over 100,000 lawsuits have been filed against the companies who make these products, including Boston Scientific Corp, C.R. Bard, Johnson & Johnson, and Endo International PLC. Last year, Boston Scientific Corps settled a few thousand cases for $119 million, while Endo International PLC settled 20,000 lawsuits for $830 million in 2014. Johnson & Johnson stopped selling mesh products in 2012 for reasons unrelated to the lawsuits, a company spokesman said
   
   

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2. Pelvic prolapse: What you need to know about this common health issue

   Jan 12, 2016 | Starts at Sixty

   Many women suffer from prolapse of the uterus, known as vaginal or pelvic organ prolapse. While it can be an embarrassing and uncomfortable issue, you should not ignore it, and you certainly don’t have to deal with it alone.

   Here’s what you ned to know about this issue and the steps you can take to gain your confidence and comfort back.What is a prolapse?

   Your pelvic organs include your bladder, uterus (womb) and rectum (back passage) and these organs are held in place by tissues called ‘fascia’ and ‘ligaments’. These tissues help to join your pelvic organs to the bony side walls of the pelvis and hold them inside your pelvis.

   If the fascia or ligaments are torn or stretched for any reason, and if your pelvic floor muscles are weak, then your pelvic organs might not be held in their right place and they may bulge or sag down into the vagina. This is known as a pelvic organ prolapse (POP).What are the symptoms?

   A prolapse won’t go unnoticed for long – in fact there are a number of obvious signs that you are suffering from this pelvic issue.

   You may feel:a heavy sensation or dragging in the vaginaa lump bulging out of your vaginapain during sexual intercourseyour bladder might not empty completelypersistent UTIstrouble emptying your bowelpersistent pain in your lower backWhat causes a prolapse?

   The main cause of a prolapse is childbirth, as a baby can stretch and tear the supporting tissues and pelvic floor muscles. Even many years on from having one or more vaginal births, you may suffer a prolapse.

   Other things that press down on the pelvic organs and the pelvic floor muscles can lead to prolapse. These include:Chronic coughingHeavy liftingObesityConstipationThe different types

   There are three main types of prolapse:Bladder prolapse (cystocele) – when the bladder bulges into the upper front wall of the vaginaBowel prolapse (rectocele) – when the rectum and or colon bulge into the lower back wall of the vaginaUterine prolapse – when the upper vagina, cervix and uterus move down into the vaginaPrevention

   If you already have a prolapse, you won’t be able to prevent it, however if you suspect you may have one in the future or are at risk due to family history, read on.

   All women should keep their pelvic floor muscles strong – no matter what their age, via pelvic floor exercises.

   Pelvic floor muscles, just like any other muscles, can be made stronger with the right exercises, though it will not cure a prolapse, so this is better dealt with by professionals.

   Here are some exercises you can do.Treatment

   If you see your doctor as soon as you suspect a prolapse, the chances of treating the issue without surgery are greater.

   Here are the usual options, those it’s best to discuss with your health professional.

   Surgery

   Surgery can repair the torn or stretched fascia and ligaments and can be done through the vagina or the stomach.

   Vaginal pessary

   A pessary is a flexible device which can be fitted into the vagina to support the uterus. There are different shapes and sizes of pessary, which can be prescribed and fitted by your doctor.

   Modification of  lifestyle factors

   Obesity, constipation and strenuous activity can cause a prolapse, so you may be asked to change some lifestyle factors to see an improvement.

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