Ethicon Media Monitoring 9/18/18

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

1. Transvaginal Mesh Victim ‘Satisfied’ by Revised Verdict of $20M

   Sep 18, 2018 | DrugWatch

   By Kristin Compton
   
   
   Barbara Kaiser who was originally awarded $25 million in punitive damages by an Indiana federal jury has now been cut down to $10 million by U.S. District Judge Philip P. Simon.
2. How safe is vaginal mesh surgery for incontinence?

   Sep 18, 2018 | Health24

   By Lauren Mitchell
   
   
   The article reports on the benefits and disadvantages of vaginal mesh surgery from a South African perspective.

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

1. Transvaginal Mesh Victim ‘Satisfied’ by Revised Verdict of $20M

   Sep 18, 2018 | DrugWatch

   By Kristin Compton

   A woman awarded $35 million after suffering severe injuries from Johnson & Johnson’s Prolift transvaginal mesh is ‘satisfied’ by a federal judge’s revised verdict of $20 million, her attorney told DrugWatch.

   Barbara Kaiser was awarded $10 million in compensatory damages and $25 million in punitive damages by an Indiana federal jury following a more than one-week-long trial on March 8, 2018.

   U.S. District Judge Philip P. Simon later cut the $25 million punitive damages awarded by an Indiana federal jury to $10 million.

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2. How safe is vaginal mesh surgery for incontinence?

   Sep 18, 2018 | Health24

   By Lauren Mitchell

   For the last couple of years, we’ve heard an outcry from women complaining about the unbearable pain caused by their vaginal mesh implants.

   Mesh reality

   Vaginal mesh implants are used to treat female patients suffering from stress incontinence or pelvic organ prolapse. These conditions are especially common in women as a result of pregnancy and childbirth.

   The vaginal mesh is a net-like material made up of either polypropylene, animal tissue or a combination of both. The mesh is inserted via the abdomen or the vagina. A transvaginal insertion of the mesh is viewed by urogynaecologist as less invasive than a transabdominal insertion.

   Jada Pinkett Smith reveals she underwent vaginal rejuvenation treatment

   Actress Jada Pinkett Smith recently talked very candidly on her Red Table Talk Facebook Watch series and revealed that she had vaginal rejuvenation treatment.

   The net-like structure of the mesh allows the tissue to grow through the mesh pores to strengthen and provide support to the affected organs. For patients suffering from stress incontinence, doctors use this mesh to create a bladder sling. The sling acts like a type of hammock, supporting both the bladder and the urethra. 

   The risk percentage for surgical mesh procedures is lower in patients with stress incontinence than those with pelvic organ prolapse. The bladder sling helps to keep the urethra closed and thereby preventing leakages. When successful, this procedure has the capability to improve the quality of life of those who had suffered from stress incontinence. 

   However, thousands of women who have undergone the procedure have reported complications regarding the mesh. These complications include burning sensations in the pelvic area and debilitating pain. In some cases, this pain has prevented some patients from returning to work, in others it has made a simple task like walking a considerable struggle. The material of the mesh also places females at risk of organ perforation.

   Life threatening

   The quality of life of many patients has significantly decreased after the procedure.

   Like Stella Channing who told Woman and Home that “You spend your day thinking that the best way to get through the day would be to drug yourself up. You take pain killers and then take sleeping tablets, so that you can try and escape the raw burning pain and the ongoing nerve pain that makes you writhe in agony.”

   The English National Health Services has reported that nearly 10% of women who have had the mesh inserted have experienced some kind of complication.

   In 2017, a vaginal mesh complication cost the life of Chrissy Brajcic. Brajcic, a Canadian woman had her mesh removed after it caused nerve damage in her pelvic area. However, after several urinary tract infections, Brajcic returned to hospital where medical staff discovered that the area where the mesh had been inserted turned septic.

   In December 2017, New Zealand became the first country to ban the use of surgical mesh in organ prolapse and incontinence procedures. Australia issued a ban on the use of surgical mesh for the treatment of organ prolapse in women.

   According to the Independent newspaper, the NHS England accepted the recommendation to temporarily ban surgical mesh procedures in England. The ban extends till March 2019, during which the product will be placed under medical review. In the United States, the Food and Drug Administration has categorised the insertion of surgical mesh as a high-risk procedure.

   South African perspective

   Two South African urogynaecologists, however, are arguing in favour of the bladder sling surgery. Dr Stephen Jefferey, who is the head of the Urogynaecology Unit at the University of Cape Town and his practice partner, Dr Pieter Kruger, who is the urogynaecology fellowship director at Groote Schuur Hospital, argue that patients are not getting the full story when it comes to surgical mesh or bladder slings.

   “Patients need to understand that there are two very different mesh products. The sling is very narrow and is a safe and effective treatment for many cases of incontinence,” said Jefferey in a Medical Brief press release. “The complications of mesh surgery are well known and should be discussed with patients. The common complications are mesh erosion and chronic pain and that can vary between 1-10%. A lot of the complications related to mesh surgery can be avoided by training sub-specialist in uro-gynaecology and choosing the correct procedure for the individual patient,” explains Kruger in the press release.

   Surgical mesh operations, like most medical procedures carry risks. However, according to several investigations, there's not enough medical research to back the use of surgical mesh in the treatment of stress incontinence or pelvic organ prolapse. 

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