Skip to content

No FDA Warning for Hernia Mesh

Food And Drug Administration Does Not Issue Warnings About Hernia Mesh

No FDA Warning for Hernia Mesh 1Jane Aker, a journalist and the current National News Editor for the Mesh News Desk (MND), posted an article for the Legal Examiner in January 2019. In her report, she calls into question the wisdom of the Food and Drug Administration’s (FDA) failure to warn people about the dangers of hernia mesh, given the history of similar surgical mesh which, in the past, has been proven to cause severe injuries to thousands of patients.

Some Background About Surgical Mesh

Surgical mesh has a controversial history. Between 2008 and 2018, the FDA investigated surgical mesh, which was used as a conventional treatment for pelvic organ prolapse (POP). The FDA determined that the mesh used to treat POP was dangerous. After initially concluding in 2008 that complications from surgical mesh were rare, the FDA reversed itself in 2011.

The increase in the number of injuries and complications caused the FDA to advise that POP surgical mesh is used “as a last resort because the benefits did not outweigh the risks.” After post-POP mesh monitoring, the FDA determined that POP mesh was to be classified as a class 3 medical device, which is one that involves the highest risk. Class 3 medical devices require clinical trials and clearance before they can be marketed to the public.

Hernia Mesh is Made From the Same Material as POP Mesh

According to Akers, hernia mesh is made from polypropylene, the same material as the POP mesh categorized as a class 3 medical device. The FDA, however, has not provided the public with updated information or warnings on its hernia mesh page since February 2018. The FDA activities page about hernia mesh has not been updated since 2017.

Manufacturers of hernia mesh have voluntarily recalled thousands of lots of these medical devices. According to Aker:

  • Bard Davol recalled Composix Kugel mesh in 2005
  • Ethicon’s Proceed surgical mesh was recalled in 2010
  • Atrium C-Que Edge remains on the market, but one lot was recalled in 2013
  • Ethicon’s Physiomesh was recalled in 2016
  • Some Atrium ProLite Mesh was recalled in 2018

Despite these manufacturers removing hundreds of thousands of hernia mesh products from the market, “the FDA seems disinterested” Aker states. She points out that the FDA has acknowledged that some complications may occur because of recalled hernia mesh. However, the number of injuries and complications being reported by patients far outnumbers the recalled hernia mesh. Akers goes on to point out that 90% of hernia repair surgeries utilize hernia mesh, and the numbers just do not add up.

The FDA continues to make no movement toward warning patients of the numerous complications that are occurring at an alarming rate. Some of the injuries being reported are similar to those that happened with POP mesh:

  • Organ perforations
  • Bowel obstructions
  • Adhesion of the mesh
  • Mesh migration
  • Piercing of tissue, muscle, organs
  • Infection
  • Pain
  • Intestinal puncture

The injuries are severe and can result in the need for multiple surgeries to not only repair the damage from surgical mesh but to remove the device as well. Yet the FDA has not provided any real warnings about these dangers to the public or medical community.

Will Hernia Mesh Litigation Make the FDA Change Its Position?

There is currently litigation in state and federal courts across the nation involving several manufacturers of hernia mesh. Plaintiffs have filed lawsuits to hold them accountable for the pain, suffering, and expenses caused by hernia mesh implants. Bellwether trials are set for June and September 2019, and the outcome may result in new information that may sway the FDA’s classification of hernia mesh.

Contact Us if You Have Been Injured by a Hernia Mesh Implant

You may be eligible to file a claim to collect monetary damages for your injuries. Call Alonso Krangle, LLP at 516-350-5555 for a free consultation and evaluation of your hernia mesh case.

 

Sources:

What Is My Case Worth?

Call 800-403-6191 or Submit This Form

Consent*
This field is for validation purposes and should be left unchanged.
I highly recommend this firm
This firm shows out standing professionalism on all levels. Mr. Krangle is attentive and diligent though the entire process. I highly recommend this firm.
C.H.
They do what they say
They do what they say. With me they were very professional in every way possible.
N. J.
They Treated Me Like I Was Family
I wanted to thank Alonso Krangle for helping me with my case. Not only were they able to get me much needed compensation for my injuries, but they kept in contact with me and explained every step of the process. They treated me like I was family.
F V
We were very fortunate to meet David Krangle
My husband and myself had been involved in a multiple vehicle accident 5 years ago. At that time we were given the name of Mr. David Krangle, attorney. It took close to 5 years of very diligent work for Mr Krangle to complete our case to everyone’s satisfaction. During those years of endless hours and hours of work that he put into our case yet whenever we reached out to Dave (as the years allowed us to call him) he was always available to us. His patience did seem endless. His professionalism in researching everything to make our turnout perfect for us was everything we expected and let us rest knowing things are following the right path. I know we were treated with the utmost respect from various insurance companies and other attorney’s because that was something Mr Krangle made sure of. In difficult times it can be intimidating to work with a professional but we were very fortunate to meet David Krangle who had the ability to share warmth and compassion with us during a trying time. Those are traits that we admired in David Krangle and are delighted to have worked with him.
ER
Excellent and fast 100% recommended to me

Excellent and fast 100% recommended to me in a matter of 7 months my request came out they are very good they treated me very well everyone thank you very much.

(Original) Excellent y rápido 100% recomendado a my en cuestión de 7 meses me salió mi demanda son muy buenos me trataron muy bien todos muchas gracias.

RMS
Mil gracias y que Dios lo bendiga
Buenas tardes Abogado para mi y mi familia fue un placer haber con sus eficientes servicios como nuestro abogado mil gracias y que Dios lo bendiga y lo siga acompañado en todos los casos que se le presenten y salga victorioso gracias 🙏
Gustavo P
Alonso Krangle LLP was absolutely wonderful handling my personal injury case
Alonso Krangle LLP was absolutely wonderful handling my personal injury case. The staff is extremely professional, prompt and helpful at all times. The attorneys truly care about their clients and their clients well being. I couldn’t be happier with their professional help throughout my entire case. I am so extremely thankful I chose to use Alonso Krangle LLP and ABSOLUTELY recommend this law firm if you have a personal injury case.
DM
You’ll be in good hands!

I was involved in an accident and needed a good Personal Injury Attorney. A friend referred me to David Krangle of Alonso Krangle LLP. After my initial phone conversation with David, I was confident that I found the right Attorney. David was not only extremely thorough, he kept me updated on every stage of my case. Most importantly, he was always available for questions and followed-up promptly. In most cases, the same day. Since there was a 3-hour time zone difference, I was very appreciative from a client stand point.

With his expertise and guidance, I had a successful outcome. I felt very fortunate that David and his wonderful staff represented me.

If you ever find yourself in need of expert legal advice and guidance. I highly recommend you contact David Krangle of Alonso Krangle LLP. You’ll be in good hands!

F. M.
Dave Krangle Worked Restlessly On This Case Until We Won
I consider David Krangle as my attorney for many years now. Going back about 13 years ago my father was involved in a hit and run accident. David had gone the extra mile to win our case….. Mr. David Krangle worked restlessly on this case until we won the case. Since then, if anybody asks for a good attorney I recommend David Krangle with confidence. He has helped a number of my friends and relatives and they all appreciated his professionalism, prompt responses to any inquiry during case development, careful study of all details pertaining to their case. He treats his clients as family. Thank you, Mr. Krangle, wishing you a continued success, good health and prosperity.
K M
Thank you very much Mr. Andres for having won my case
I am very grateful for your excellent work, everything was professional. Thank you for giving me tranquility and for having so much patience with me and for the success and for the sweetness of Leslie. Once again, thank you very much Mr. Andres for having won my case.
JD
The world needs more people like yourself

I want to thank you for your kindness and compassionate communication through this process. I truly want to thank you for your time and for being such an advocate for people! The world needs more people like yourself .

All my best to you,

C
Express Our Thank You To You For The Wonderful Job You Did With Our Daughter’s Case

Dear Andres,

We wanted to express our thank you to you for the wonderful job you did with our daughter’s case. You are a true professional and we are thankful that you are the one who helped us all through this. We couldn’t have asked for anyone better to have on our daughter’s side.

Respectfully,

Parent A B
My highest recommendation!
David – You are very smart, honest, knowledgeable and efficient! My highest recommendation! Any interested persons may contact me, Best,
Mr. S
I want to thank you for all your hard work and efforts in resolving our case
I want to thank you for all your hard work and efforts in resolving our case. I also want to thank you for personally responding to my calls… I realize that you have people that could have taken care of that for you…. But it meant a lot to me!!
S.L.
Thank You From The Bottom Of My Heart For All Your Help

Andres,

I just want to thank you from the bottom of my heart for all your help. Tonight is the first night since January that I can finally breath a sigh of relief. Your determination and dedication to my case was by far beyond what I could ever imagined.

W W
Excellent job
Some People just go the extra mile, Thanks for being one of them. Excellent job David!
VL
Exceeded My Expectations
Thank you for your persistence…. Once again, I thank you for your expertise in my case. You’ve exceeded my expectations.
RG
I can’t thank them enough for going above and beyond for me
Great law firm. Highly recommend them and I’m so glad that I found them. Everyone from David Krangle to his staff were very caring and sensitive when it came to my case. Always kept me up to date with every single update and were there for me professionally and emotionally every step of the way. It was a very difficult time in my life but dealing with everyone at Alonso Krangle made it so much easier to get through everything. I can’t thank them enough for going above and beyond for me.
AN
I appreciate both of you lawyers
I appreciate both of you lawyers… You will do good for new clients!
RS
Making Sure I Get All The Therapy I needed Very Concerned About Your Situation On Your Side Taking Care Of All The Legal Issues
Where should I start from day one Mr. Krangle was on the phone for me making sure I get all the therapy I needed , Hes great about getting back to you right away should he happen to miss your call. Although, hes usually available. He is extremely attentive, and informative throughout the whole process. Its already stressful enough situation with all your injuries, doctors appointments, etc., so its good to have someone on your side taking care of all the legal issues. He is also very concerned about your situation .. Always stayed in contact he was just a phone call away literally .. If I can give him 10 stars I will. Hes the guy to see Thanks for everything, David -NF
David – NF
Strongly Recommend Alonso Krangle As a Highly Experienced And Respected Firm

I consulted a close friend and well respected lawyer in the mid-Atlantic region regarding my hip revision surgery due to a medical device recall. Without hesitation, he strongly recommended contacting Alonso Krangle LLP to discuss my case. In his view, Alonso Krangle possessed extensive knowledge and experience in the type of litigation my case required, as well the respect of those throughout the judicial field for their professionalism. Equally as important, their personal focus on each individual’s case gives the client a feeling they are their only concern. My friend’s assessment could not have been more accurate.

Although in New York, Alonso Krangle could not have been more responsive or accommodating if they were located here in Virginia. I cannot recall a single time when my wife or I called their office and did not speak to either Andres Alonso or David Krangle. They were always completely available and ready to answer any and all of our questions. Their advice and recommendations were always honest, sincere, and accurate enabling us to plan accordingly. Legal proceedings can be a long process, but we never felt left out or forgotten thanks to timely updates initiated by Alonso Krangle. In the end, everything turned out as Alonso Krangle estimated from the beginning. I could not have expected better personal attention or concern from a family member handling my case. As with my friend, I too, would not hesitate to strongly recommend Alonso Krangle as a highly experienced and respected firm that will treat you like family.

LM and MM
Thank you for everything you have done for me
David-Thank you for everything you have done for me. I appreciate you guys
JB
Exceptional law firm
Exceptional law firm with wonderful & helpful staff
I. D.
Thank you for being there for me
Thank you for being there for me. Thank you for helping me, I so appreciate what you did for me. Please extend my thanks to your staff also
DR
I love the whole damn firm!

I really only have just a statement. I LOVE YOU!! I also LOVE Alonso, I LOVE Krangle… I love the whole damn firm!

I definitely know the pain and suffering I went through… but I never thought you guys would be able to pull something off this awesome.

Much much love to my favorite people in New York… and about 47 other states.

R
Great job guys, thanks
I have been involved in lengthy litigation against a giant pharmaceutical company over the past several years. Alonso Krangle has been with me every step of the way, and has kept me up with the progress of my case. As their slogan says, they “Fight For Victims”. Great job guys, thanks.
V. L.
Thank you for your years of service

I want to take this opportunity to again say thank you for your years of service working on my case, I sincerely appreciate you.

Respectfully,

VL
Kept Us Informed Every Step Of The Way And Made Sure All Our Questions Were Answered
David came recommended to me from a member of my family and now I know why . He achieved a very good result for my case. He kept us informed every step of the way and made sure all our questions were answered.
D G
Highly recommend
Very professional law firm. Highly recommend.
B. M.
Absolutely Instrumental in Helping Me Expose Medicare Fraud That My Former Employer Was Engaging In
When you have to fight Goliath you better call David. Dave was absolutely instrumental in helping me expose Medicare fraud that my former employer (one of the largest pharmaceutical companies in the world) was engaging in. Dave took the time to listen to my concerns and my evidence. He worked tirelessly to bring the best resources to table so that our case would be investigated thoroughly and prosecuted. In the end, the Goliath was defeated thanks to Dave!
Mark W
I am very pleased with the handling of my case by the Law Firm of Alonso and Krangle
I am very pleased with the handling of my case by the Law Firm of Alonso and Krangle. They did an excellent Dave Krangle is an extremely professional and knowledgeable attorney, a true gentleman. Leslie Escobar was helpful and caring at all times I would recommend this law firm to anyone who may have a personal injury case.
SM
Like To Express My Appreciation To You And Your Firm
I just would like to express my appreciation to you and your firm for assisting me with this matter. I am now a single mother of six children and I have been going through so much financial strife. I did not know how I would get school supplies for my children so I have been working two jobs to try to gain some extra funds. This is a blessing to me and my children. Thank you again for all you guys have done for us.
MC

Want to Know What Your Case May Be Worth?

Complete this form or call 800-403-6191 to find out if you have a claim and what you may be able to recover for your damages.

Consent*
This field is for validation purposes and should be left unchanged.