The Future of Mesh Implants
Lately I have begun to wonder about the hundreds of thousands of women who have a mesh implant now and what will happen to them over many years, especially, will there be any compensation for the badly injured women from long term implants. I have seen so many women who have had an implant for many years and only the lucky few will be able to have it completely removed by clever and competent doctors. The rest will live a life of pain, addiction to pain medications and/or become bedridden for the rest of their lives.
With mesh manufacturers either trying to grow at an alarming rate or selling off their women’s implant departments, there has been a huge shift over the past five years since the 2011 warning by the FDA and women began filing lawsuits. Regardless of the wins in trials that have taken place for badly injured women, these manufacturers are still declaring there is nothing wrong with the products and they are trying hard not to give women any comentsation. They are going to fight tooth and nail to continue doing business as usual and sadly some medical organizations such as American Urogynecologic Society (AUGS)
will do everything possible to stop the negativity surrounding these implants. I want you to read part of the statement on their site.
- Polypropylene material is safe and effective as a surgical implant. Polypropylene material has been used in most surgical specialties (including general surgery, cardiovascular surgery, transplant surgery, ophthalmology, otolaryngology, gynecology, and urology) for over five decades, in millions of patients in the US and the world (personal communication with manufacturers of polypropylene suture and mesh). As an isolated thread, polypropylene is a widely used and durable suture material employed in a broad range of sizes and applications. As a knitted material, polypropylene mesh is the consensus graft material for augmenting hernia repairs in a number of areas in the human body and has significantly and favorably impacted the field of hernia surgery. As a knitted implant for the surgical treatment of SUI, macroporous, monofilament, light weight polypropylene has demonstrated long term durability, safety, and efficacy up to 17 years.
- The monofilament polypropylene mesh MUS is the most extensively studied anti- incontinence procedure in history. A broad evidence base including high quality scientific papers in medical journals in the US and the world supports the use of the MUS as a treatment for SUI. There are greater than 2,000 publications in the scientific literature describing the MUS in the treatment of SUI. These studies include the highest level of scientific evidence in the peer reviewed scientific literature. The MUS has been studied in virtually all types of patients, with and without comorbidities, and all types of SUI. Multiple randomized, controlled trials comparing types of MUS procedures, as well as comparing the MUS to other established non-mesh SUI procedures, have consistently demonstrated its clinical effectiveness and patient satisfaction. Among historical SUI procedures, the MUS has been studied as long in follow-up after implantation as any other procedure and has demonstrated superior safety and efficacy. No other surgical treatment for SUI before or since has been subject to such extensive investigation.
- Polypropylene mesh midurethral slings are a standard of care for the surgical treatment of SUI and represent a great advance in the treatment of this condition for our patients. Since the publication of numerous level one randomized comparative trials, the MUS has become the most common surgical procedure for the treatment of SUI in the US and the developed world. This procedure has essentially replaced open and transvaginal suspension surgeries for uncomplicated SUI. There have been over 100 surgical procedures developed for the management of SUI and there is now adequate evidence that the MUS is associated with less pain, shorter hospitalization, faster return to usual activities, and reduced costs as compared to historic options that have been used to treat SUI over the past century. Full-length midurethral slings, both retropubic and transobturator, have been extensively studied, are safe and effective relative to other treatment options and remain a leading treatment option and current gold standard for stress incontinence surgery.] Over 3 million MUS have been placed worldwide and a recent survey indicates that these procedures are used by > 99% of AUGS members.
- The FDA has clearly stated that the polypropylene MUS is safe and effective in the treatment of SUI. The midurethral sling was not the subject of the 2011 FDA Safety Communication, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Vaginal Placement for Pelvic Organ Prolapse.”] In this document, it was explicitly stated: “The FDA continues to evaluate the effects of using surgical mesh for the treatment of SUI and will report about that usage at a later date.” In 2013, the FDA website stated clearly that: “The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year.”
The polypropylene midurethral sling has helped millions of women with SUI regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly. With its acknowledged safety and efficacy, it has created an environment for a much larger number of women to have access to treatment. In the past, concerns over failure and invasiveness of surgery caused a substantial percentage of incontinent women to live without treatment. One of the unintended consequences of this polypropylene mesh controversy has been to keep women from receiving any treatment for SUI. This procedure is probably the most important advancement in the treatment of stress urinary incontinence in the last 50 years and has the full support of our organizations which are dedicated to improving the lives of women with urinary incontinence.
I have written about this organization before and it is my suggestion that you find out if your doctor is a member before you go back to see them for any female problems you have and because you cannot access members on this site, I would ask them directly. Or if you are searching for a doctor, I would inquire about their membership before you make an appointment. If they are afraid to list the doctors who belong to their organization, there is a HUGE problem with this organization. They are determined to ignore all the warnings by the FDA and any doctor who belongs to it, won’t believe you if you find yourself with serious issues soon after or many years later after they implant a mesh product.
So now you may wonder what is happening to women over the long term of an implant and I am going to share with you, some of the latest comments left on this blog.
“Thank You! for sharing your symptoms. After having intermittent numbness in leg and butt after long drives to the city, I woke up on Dec 6, 2015 to find my nether regions permanently numb. Since then, I have been to all kinds of Dr and had all kinds of tests run, trying to find the source of my pain. I can’t sit, stand, walk or drive for any length of time without radiating nerve pain that starts in my mid butt region down back of thigh, calf and bottom of my feet (which feel tingling with patchy numbness as well). It’s very debilitating and limiting. Through all this time, I heard, “bladder mesh” a few times and it was more like these Dr were thinking out loud vs talking to me directly. In any case, at my wits end, I decided to look it up. I had had a bladder sling (Boston Scientific Lynx, it turns out) put in, in Dec 7, 2006 to fix incontinence. As far as I was concerned, it worked. However, looking back, I would rather have incontinence, than this kind of pain.
I have looked all over Facebook and the web and hadn’t really found anyone else that described the leg pain or groin numbness, til now. I’m guessing the groin numbness is rare. For me it is only in my right leg. I have piriformis pain on my left side, which came on after the right leg pain and is probably due to compensation. (sitting half on a cushion and half off, in order to avoid pressure on right side). Silly me.
My next step is to see if Dr Raz will take my insurance and see about getting this out. I won’t hold my breath, but for now, I do have hope.
That woman was implanted ten years ago. Note the type of sling that was implanted in her. Boston Scientific just went to a judge to try to overturn some of the lawsuits against their products. Read this.
Boston Scientific yesterday lost its bid to overturn an $18.5 million loss in a product liability lawsuit brought by a quartet of women alleging that its Obtryx pelvic mesh caused their injuries.
A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed).
Boston Scientific last year asked Judge Joseph Goodwin, of the U.S. District Court for Southern West Virginia, to overturn the verdict, arguing that the plaintiffs failed to show that Obtryx is not reasonably safe because it’s within the standard of care for stress urinary incontinence. The plaintiffs also failed to link any of their injuries to specific design flaws, the company argued, and likewise didn’t prove their failure to warn claims. Boston Scientific also argued that the punitive damage awards were excessive and caused a miscarriage of justice.
The judge said “NO”.
“Because I find that the plaintiffs’ experts specifically connected at least 1 of the above defects to each plaintiff’s injuries, a reasonable jury would have no need to ‘infer the existence of a defect by circumstantial evidence,'” he wrote. “The design defects discussed above, which were specifically linked to the plaintiffs’ injuries through expert testimony, likewise could have been revealed through clinical testing of the Obtryx. Therefore, a reasonable jury could find that BSC’s failure to conduct clinical trials before marketing the Obtryx proximately caused the plaintiffs’ injuries.
“In sum, BSC knew that safety issues can arise when a product does not undergo clinical testing, failed to respond to explicit warnings from the manufacturer that polypropylene should never be used permanently in the human body, and suggested hiding negative studies to physicians considering using the Obtryx. Drawing all inferences in the light most favorable to the plaintiffs, I find that a reasonable jury could use this evidence to conclude that BSC’s conduct justified an award of punitive damages,” Goodwin wrote.
If you are an injured woman of a B.S implant you may be concerned that they will go bankrupt and you will not receive any compensation for your injuries. Now read their latest acquisition approved by the U.S Government.
The Department of Defense awarded Boston Scientific a contract worth up to $71 million to supply it with cardiovascular devices. The one-year deal could potentially be extended another four years, according to the DOD. Under the contract, the Massachusetts devicemaker will supply cardiovascular products to the Army, Navy, Air Force, Marine Corps and federal civilian agencies.
Boston Scientific’s cardiovascular business is the company’s largest. It logged a couple of key FDA nods in 2015, namely the February approval of its stroke-fighting Watchman after setbacks in 2010 and 2014 and the October OK for its Synergy stent, the first partially bioresorbable stent.
That was in 2015 but they are still growing and getting bigger. Like I said some companies are growing at an alarming rate.
As for 2016, the company nabbed a CE mark for its next gen TAVR, the Lotus Edge Valve System. Also in 2016, Boston Scientific rolled out a cloud based digital care platform in partnership with Accenture, which aims to provide hospitals with more insight into their chronic cardiovascular patients. The Advantics Care Pathway Transformation is focused on evaluating the care delivery for heart failure patients and how it can be improved.
Wait they are getting even bigger.
Outside of cardiovascular, Boston Scientific inked a deal to acquire Endo Choice for approximately $210 million, boosting its endoscopy offerings. And in July, the company picked up Cosman Medical for an undisclosed amount to gain ground in neuromodulation. Endoscopy and Neuromodulation, along with Urology/Pelvic Health, make up the company’s Medsurg unit, its second largest business. How do you feel now if you are suffering from a B.S. implant like I am.
The next woman was implanted in 2011, five years ago and just before the FDA warning in July that year.
“I have truly been through hell and back. I have just come from a neurologist office who did an EMG and then told me my symptoms were fybromyalgia not nerve damage but just this morning I was seen by a second urogynecoligist that said he did see evidence of nerve damage based on a test that he did then mentioned a pudendal Nerve block. I had a partial hysterectomy and transobulator mesh sling inserted in June of 2011. In 2013 I started to develop a pinch in my vagina I went to my obgyn believing that it was my endometriosis he confirmed the pain was from the sling and it needed to be cut back. In February of 2014 I had the procedure to do just that and by July of 2014 I was back in to have a revision due to pain down my groin and left leg. In 2015 I developed pain in my buttocks and a burning sensation I couldn’t sit at my desk at work I went to my obgyn again who said the sling needed to be removed he recommended the best surgeon in my area and off I went to his office. Unfortunately, he passed away before I could have it removed but absolutely agreed that it was the mesh sling that caused the pain and that the specific one I had was known to do exactly that.
In April of 2016 I saw one of his associates and she agreed to remove the mesh and that was absolutely the worse day of my life June 30 2016. I came out of that procedure knowing something was very wrong it has been over 2 months and I have been out of work from a pain that runs down my left groin up the side of my vagina around my hip down my leg into my foot. I have been to my internist orthopedic pain management physical therapist uro gynecologist urologists and neurologist. I lay in bed truly wanting to die from what has happened to me. I am scared of what I know this mesh has done to my body. I am 45 years old a wife and a mother of 2.” I feel terrible for this woman but I also know many doctors who are removing mesh DO NOT KNOW WHAT THEY ARE DOING and will cause EVEN MORE DAMAGE. I learned all this when I spoke to many women and it was then I decided to travel far from home to UCLA to have mine removed FOUR years ago this month.
Another woman left the following comment recently and I did get in touch with her and thank God, Dr. Raz removed all her mesh from 14 years of implant. She is now home recuperating. Read this.
Thank you for creating this site. I will be having my surgery end of Sept 2016. I’ve been suffering for 14 years with fever , walking issues, bladder urgency and failed tvt ,and autoimmune issues…..the Dr who did my surgery in 2002, in NYC, still uses the mesh !!!!!! even when she does surgery in Africa…..SCARY…she is now listed as a super doctor in the new listings besides top doctor.”
So what about Johnson & Johnson. They too are settling claims right now but they are also very busy working on new devices that will fix the problems that mesh implants cause in the first place. Read this.
The FDA approved St. Jude Medical’s physician-designed spinal cord stimulation system for the treatment of chronic pain. Treatment with the BurstDR system differs from traditional SCS therapy in that it delivers “burst” pulses of stimulation that mirror the body’s natural nerve impulses.
In SCS, an implant is placed beneath the skin to deliver neurostimulation to a patient’s spinal cord. A number of players, such as Medtronic and Nevro, are studying neurostimulation for various indications, including movement and psychological disorders and overactive bladder in addition to chronic pain management. No kidding. So much of this is caused by mesh implants that they are responsible for getting doctors to put them in women in the first place. Talk about play both sides of the coin.
“Chronic pain is one of the most costly epidemic diseases facing health care systems worldwide, and one of the most challenging for physicians to manage due to the complexity of the condition and the differences in each patient’s clinical case,” said Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical, in a statement. Many patients seeking treatment for chronic pain find only partial relief. By echoing the body’s natural pain response patterns, St. Jude’s BurstDR offers a “more complete” pain management option, the company said.
The approval of St. Jude’s BurstDR system comes after a decade of work, the company said in the statement. It was found in a prospective, randomized, multicenter study to provide “superior pain relief” over traditional spinal cord stimulation, according to the statement. Most of the trial participants preferred BurstDR over traditional therapy.
Other companies are working on stimulation that mimics patients’ natural nerve impulse patterns, but BurstDR is the first FDA-approved form of burst stimulation that has been assessed in a large-scale trial, according to the company. The treatment will be available immediately to patients getting new implants of the Proclaim Elite and Prodigy MRI spinal cord stimulation systems. Patients who have already received the upgradeable Protég and Proclaim systems will soon be able to upgrade their systems and receive BurstDR therapy, St. Jude said in the statement.
Yes, I am feeling quite disgusted as I write this blog this morning and I am so afraid for the future of injured women because of mesh implants.
Please read the last blog I wrote about AUGS before you search for any doctor to go to. http://www.meshangels.com/the-fight-to-save-lives/