FDA Bans Sales of All Transvaginal Mesh

Transvaginal Mesh Sales Halted

The U.S. Food and Drug Administration (FDA) has ordered makers of transvaginal surgical mesh implants to immediately stop the distribution and sale of the products in the United States.

The FDA said that Boston Scientific and Coloplast, the last two companies selling these products in the U.S., have not demonstrated “a reasonable assurance of safety and effectiveness for these devices”.

Transvaginal Mesh Used for Pelvic Organ Prolapse

Transvaginal mesh is used in surgery to repair pelvic organ prolapse (POP) a common medical condition in which the muscles and tissue supporting the pelvic organs (the bladder, uterus, and rectum) become weak or loose. This allows the pelvic organs to press on, into, or out of the vagina. One in eight women will have surgery to repair POP over her lifetime.

History of FDA and Transvaginal Mesh

The FDA approved the first pelvic mesh device for transvaginal repair of POP as a class II moderate-risk device in 2002. Since then, thousands of women and their doctors have filed complaints of injuries resulting from implanted vaginal mesh after POP surgery. The agency issued its first safety communication about pelvic mesh in 2011.

The FDA reclassified vaginal mesh as Class III (high risk) in 2016. As a result of the reclassification, manufacturers were required to obtain premarket approval applications (PMAs), the FDA’s most stringent method of approving medical devices. Some manufacturers voluntarily recalled or discontinued vaginal mesh in the last few years as safety concerns grew.

FDA Ended Sales for Safety of Patients

In reviewing the PMA data submitted by Coloplast and Boston Scientific, the FDA determined that the data didn’t show surgery using mesh was better than surgery using native tissue. Therefore, the benefit of mesh did not outweigh the risk of injury, and the products are not safe to use.

Even though they can no longer sell the devices, Boston Scientific and Coloplast are “required to continue follow-up of the subjects already enrolled in their 522 studies.”

What To Do If You Have Defective Transvaginal Mesh

Any woman who has implanted mesh for POP who is having pain or other complications should contact her doctor immediately. The injuries caused by defective transvaginal mesh include infection, vaginal bleeding or discharge, severe pelvic or groin pain, pain during intercourse, urinary problems, and even organ perforation from implanted mesh eroding into surrounding tissues. Do not delay seeking medical attention if you are in pain.

If you have been injured by a defective transvaginal mesh implant and would like to explore your legal options, call the pelvic mesh lawyers at Thornton Law Firm to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your legal rights. 

Johnson & Johnson Hit With $57M Verdict in Pelvic Mesh Case

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By: Marilyn McGoldrick, Esq.

Published on September 6, 2017

Johnson & Johnson’s Ethicon subsidiary was ordered to pay plaintiff Ella Ebaugh $57 million dollars for injuries she suffered from their transvaginal mesh implants. The verdict, rendered in Philadelphia Common Pleas Court, was the largest verdict in the Philadelphia  mass tort litigation.

Ebaugh, 51, was treated for stress urinary incontinence (SUI) with J&J mesh implants called TVT and TVT-Secur. While the implants successfully treated that minor condition initially, later the mesh eroded into her urethra. Three surgeries were required to remove the mesh.  According to her lawsuit, Ebaugh’s injuries included extensive scarring to her urethra, intrinsic sphincter deficiency, chronic urinary tract infections, chronic pelvic pain and dyspareunia, or chronic pain during sex. She has been unable to work since the mesh eroded.

The jury awarded $7.1 million in compensatory damages, and $50 million in punitive damages. It is the fifth successive multi-million dollar award against J&J and its Ethicon unit in a pelvic mesh case. You can read more about the previous awards here: Belz ($2.16 million); Engleman ($20 million);  Carlino ($13.5 million);  and Hammons ($12.5 million).

J&J and Ethicon plan to appeal the verdict.

Attorney Marilyn McGoldrick leads Thornton Law Firm’s vaginal mesh injury team. We represent women in claims against Boston Scienific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Mentor Worldwide, and Sofradim/Covidien, as well as against Johnson & Johnson’s Ethicon unit. If you have pelvic mesh implant and have experienced side effects, including mesh erosion, mesh contraction, infection, pain, urinary problems, severe pelvic pain, bleeding, vaginal tightening or shortening, inability to engage in sexual intercourse, painful sexual intercourse, additional surgeries, or organ perforation, and would like a  confidential and fair evaluation of your legal claim, please call us at our toll free number 1-888-341-1405, or tell us your story on the online. Time limits for filing legal claims are short and strictly enforced. Seek legal advice immediately about your defective mesh implant.

 

J&J’s Ethicon To Pay $2.16 Million In Pelvic Mesh Verdict

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Call 1-888-341-1405 for a free consultation with a recognized leader in personal injury and medical device litigation. You can also contact us online to discuss the details of your case.

By: Marilyn McGoldrick, Esq.

Published on June 5, 2017

A Pennsylvania state court jury awarded $2.16 million in damages to a woman with an Ethicon ProLift +M  Pelvic Floor Repair System which eroded inside her body and cannot be removed.  This is the fourth consecutive win for plaintiffs in the Philadelphia Court of Common Pleas, and the fourth multi-million dollar award against Johnson & Johnson and its subsidiary Ethicon. It is the first time  punitive damages were not awarded.

The award is entirely compensation for the plaintiff’s injuries, including lost income, medical bills, and extreme pain and suffering. Diagnosed in 2006 with Pelvic Organ Prolapse (POP), a common condition in women who have had children,  plaintiff Sharon Belz was implanted with an Ethicon Prolift+M system.  The product, a large piece of polypropylene mesh, is used to help support pelvic organs which have prolapsed or fallen out of position. The ProLift+M  was recalled by Johnson and Johnson in 2012, seven years after it was first placed on the market.

After the mesh began deteriorating in Mrs. Beltz’s body, surgeons attempted to remove it, but were unable to do so.  As a result, she suffered and continues to suffer.  Court filings describe her condition:

“Mrs. Beltz’s problems are thus permanent. She may elect to undergo further pain injections, resection of the mesh, or start taking pain medications regularly, but these options at best will only mitigate her symptoms. She has to live the remainder of her life with constant pelvic pain, a sensation her bladder is pulling, urinary incontinence and retention, lower flank pain, urinary tract infections, and severe pain with sex that lingers days after she has intercourse, ….. She will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life.”

The Beltz jury concluded that the risks presented by the mesh far outweighed the benefits, and that was the basis for their award of compensatory damages. However, the jury did not find that the ProLift+M mesh was defective, nor that Ethicon/J&J failed to warn the plaintiff and her doctors. In the three previous verdicts against Ethicon, the juries did rule that Ethicon’s mesh implants were a defective product, and that Ethicon and Johnson & Johnson failed to warn that the mesh was defective. In those cases, the verdict was included a punitive damages award: Engleman ($20 million);  Carlino ($13.5 million);  and Hammons ($12.5 million).

Thornton Law Firm’s pelvic mesh injury team represents women in claims against Johnson & Johnson’s Ethicon unit, as well as  against Boston Scientific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Mentor Worldwide, and Sofradim/Covidien. If you have a vaginal mesh implant and have experienced any side effects, including infection, pain, bleeding, mesh erosion, mesh contraction, urinary problems, severe pelvic pain, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, additional surgeries, or organ perforation, and would like a  confidential and fair evaluation of your legal claim, please call us at our toll free number 1-888-341-1405, or tell us your story on the online. The legal time limits for filing claims are very short and strictly enforced, so seek legal advice as soon as possible about your transvaginal mesh implant.

J&J Ordered to Pay $20 Million to Victim of Defective Pelvic Mesh

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By: Marilyn McGoldrick, Esq.

Published on May 2, 2017

A Pennsylvania state court jury in Philadelphia concluded that Johnson & Johnson’s TVT-Secur mesh, designed to treat incontinence in women, was defectively designed and caused Margaret “Peggy” Engleman’s injuries. The jury awarded her $2.5 million in compensatory damages for pain, suffering and economic loss and then punished J&J and its Ethicon unit with $17.5 million in punitive damages.

Ms. Engleman received the TVT-Secur transvaginal mesh implant in 2007 to treat her stress urinary incontinence (SUI).  SUI is a common medical issue, especially in women who have given birth; the mesh is supposed to support the urethra and prevent leaks. However, within one month of receiving the TVT-Secur implant, it failed, and Ms. Engleman began experience urinary incontinence again. Within a few months the mesh began to erode inside her body, causing her to experience severe pain. Despite undergoing three separate surgeries under general anesthesia to remove the eroded mesh, her doctors have been unable to remove it all, and she still experiences pain and urinary dysfunction to this day.

“I’m happy I could be a voice for other women,” Engleman said in a statement released after the verdict. “It’s been a nightmare, and I feel justice was truly served today.”

This is the third eight figure award against Johnson & Johnson in a pelvic mesh trial in Philadelphia.  A Toms River, New Jersey woman was awarded a $13.5 million mesh verdict in 2016, and an Indiana woman was awarded $12.5 million in 2015.

If you believe you have a vaginal mesh lawsuit, Thornton Law Firm’s pelvic mesh team represents women in claims against the major mesh manufacturers including Boston Scientific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Ethicon/Johnson & Johnson, Mentor Worldwide, and Sofradim/Covidien. If you have suffered side effects from your mesh implant, including but not limited to bleeding, mesh erosion, constant pain, mesh contraction, urinary problems, additional surgeries, infection, vaginal tightening, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation, you may have a claim for damages. Please call attorney Marilyn McGoldrick at our toll-free number 888-341-1405, or tell us your story using our online contact form for a  no-cost, completely confidential evaluation of your legal rights. The time limits for filing all legal claims are short. Do not delay seeking legal advice.

$13.5 Million Dollar Pelvic Mesh Trial Verdict Against J&J

By: Marilyn T. McGoldrick, Esq.

Posted on February 12, 2016

A Philadelphia jury has awarded $13.5 million to Sharon Carlino who claimed permanent damages from an Ethicon TVT midurethral sling mesh implant. This was the second verdict against Johnson & Johnson’s Ethicon unit in a pelvic mesh case. In December a jury awarded $12.5 million against J&J for injuries caused by another mesh product, the Ethicon ProLift pelvic organ prolapse repair kit.

The jury found that the TVT (Trans Vaginal Tape) mesh sling was not reasonably safe, and that the plaintiff’s surgeon would never have used it had he been warned of the risks. The jury awarded $3.5 million in compensatory damages and $10 million in punitive damages to Mrs. Carlino. $250,000 was awarded to her husband for injury to their marital relationship.

Sharon Carlino was implanted with the TVT mesh implant in 2005 to treat her stress urinary incontinence (SUI). She had sharp pains in her vagina and in 2007 and 2010 her doctor performed surgery to remove exposed mesh. Despite the surgeries Carlino continues to have pain to this day.

Ethicon has indicated that it will appeal the verdict.

Thornton Law Firm’s transvaginal mesh team represents women in claims against Boston Scientific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Ethicon/Johnson & Johnson, Mentor Worldwide, and Sofradim/Covidien. If you have a mesh implant and have experienced any side effects, including but not limited to mesh erosion, bleeding, persistent pain, mesh contraction, urinary problems, additional surgeries, infection, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation, please call attorney Marilyn McGoldrick at our toll free number 888-341-1405, or tell us your story using our online contact form for a free, confidential evaluation of your legal rights. The time limits for filing all legal claims are short. Do not delay seeking legal advice.

Did Boston Scientific Smuggle Pelvic Mesh from China?

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Call 1-888-341-1405 for a free consultation with a recognized leader in 
personal injury and medical device litigation. You can also contact us online to discuss the details of your case.

By: Marilyn McGoldrick, Esq.

A new lawsuit accuses transvaginal mesh manufacturer Boston Scientific of smuggling counterfeit pelvic mesh materials from China. Boston Scientific is charged with intentionally defrauding and endangering women by secretly importing defective polypropylene resin that wasn’t approved by the FDA.

According to the suit, the FDA gave 510(k) approval to Boston Scientific’s pelvic mesh devices made with polypropylene resin pellets (known as “Marlex”) manufactured by Chevron Phillips Chemical Co. But in 2005 Chevron Phillips stopped selling Marlex to them, warning that polypropylene resin should not be used in any product “involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

In 2011, running out of their supply of Marlex (the only mesh ingredient the FDA had approved), Boston Scientific embarked on a worldwide search for a replacement product. Their search led them to Chinese supplier EMAI Plastic Raw Materials Inc., a “known counterfeiter of plastic products,” in Guangzhou, China, which claimed to have Marlex manufactured by Chevron Phillips in storage. According to the suit, “EMAI had no paperwork documenting that the product was authentic Marlex.”

To avoid detection, the material was packaged into 500 separate bags and shipped by three ocean shipments on three different dates. The complaint charges that “The deception went to high levels within BSC. There is evidence that a BSC executive made separate and contradictory reports about the origin of the resin in order to clear Chinese Customs, and then U.S. Customs.” After being smuggled, the resin was processed at Boston Scientific subsidiaries around the world and marketed to the as many as 55,000 women per year who receive transvaginal mesh implants manufactured by Boston Scientific.

Filed as a RICO (Racketeering and Corrupt Organizations Act) action, the lawsuit seeks class action status for all women who have received Boston Scientific mesh since September 2012. In addition to Boston Scientific, the defendants include Chinese supplier EMAI Plastics Raw Materials Inc., and two Boston Scientific subsidiaries, Proxy Biomedical Limited of Galway, Ireland and Luxilon Industries NV of Belgium. The lawsuit was filed in federal court in West Virginia, where all federal lawsuits for defective mesh claims are consolidated.

Boston Scientific issued a statement denying the lawsuit’s claims.

Earlier this month, the FDA reclassified surgical mesh for Pelvic Organ Prolapse (POP) a “high-risk” medical device. The agency has received tens of thousands of complaints of side effects from transvaginal mesh implants, including bleeding, pain, infection, mesh contraction, mesh erosion, mesh protruding into the vagina, urinary problems, severe pelvic pain, vaginal tightening or shortening, additional surgeries, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation. More than 70,000 lawsuits have been filed by women who have suffered complications after receiving pelvic mesh implants.

Women who have been injured by a defective transvaginal mesh implant can contact the transvaginal mesh lawyers at Thornton Law Firm for a free, no-obligation consultation. You can tell us your story online or call Attorney Marilyn McGoldrick at 888-341-1405 for a confidential evaluation of your legal case. Time limits for filing claims are short, so don’t delay seeking legal advice.

$12.5 Million Transvaginal Mesh Verdict Against J&J


Call 1-888-341-1405 for a free consultation with a recognized leader in 
personal injury and medical device litigation. You can also contact us online to discuss the details of your case.

By Marilyn McGoldrick, Esq.

An Indiana woman was awarded $12.5 million dollars against Johnson & Johnson’s Ethicon unit in damages for the injuries she suffered from their ProLift transvaginal mesh implant. The Court of Common Pleas jury awarded $5.5 million dollars in compensatory damages and added $7 million dollars in punitive damages to punish Johnson & Johnson for recklessly marketing the device.

Plaintiff Patricia Hammons, age 65, underwent surgery in 2009 for bladder prolapse, and received a ProLift pelvic organ prolapse repair kit to support the area. Shortly after the surgery, she experienced pain, including painful sexual intercourse, and had several corrective surgeries attempting to remove the mesh which had bunched up inside her pelvis.

Plaintiff’s experts testified that completely removing the mesh was exceedingly difficult, if not impossible, describing it as a “surgical train wreck”.  In testimony that may have influenced the jury’s award of punitive damages, J&J’s own product engineer Scott Ciarrocca testified that no one at the company had given any thought as to what to do if the product failed.

Nationwide, there have been 16 verdicts against Johnson & Johnson for defective pelvic mesh implants, totaling $247 million dollars. It is estimated that there are over 100,000 cases pending nationwide against Johnson & Johnson and the other makers of transvaginal mesh products.

Thornton Law Firm’s pelvic mesh team represents women in claims against Johnson & Johnson’s Ethicon unit, as well as  against Boston Scientific, Caldera, Coloplast, Cook Medical, C.R. Bard, Inc., Mentor Worldwide, and Sofradim/Covidien. If you have a transvaginal mesh implant and have experienced any side effects, including infection, pain, bleeding, mesh erosion, mesh contraction, urinary problems, severe pelvic pain, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, additional surgeries, or organ perforation, and would like a no-obligation, completely confidential evaluation of your legal claim, please call us at our toll free number 1-888-341-1405, or tell us your story using our online contact form. The legal time limits for filing claims are very short, so do not delay seeking legal advice.

$100 Million Mesh Verdict Against Boston Scientific

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by Marilyn T. McGoldrick, Esq.

A  Delaware jury awarded $100 million dollars to a woman who suffered vaginal scarring and constant pain after receiving transvaginal mesh implants made by Boston Scientific. The Delaware state court jury awarded $25 million in compensatory damages and $75 million in punitive damages to Deborah Barba, age 51. Mrs. Barba was implanted with Boston Scientific’s Advantage Fit and Pinnacle transvaginal mesh (TVM) products in 2009 to treat to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Thousands of women have been implanted with similar mesh products to treat POP and SUI over the last decade.  Thornton Law Firm represents women across the United States in lawsuits against various pelvic mesh manufacturers for the serious injuries those implants have caused.

The jury found that the mesh implants were defectively designed and manufactured, and that Marlborough, Massachusetts-based Boston Scientific failed to warn doctors and patients of the risks. Mrs. Barba suffered vaginal scarring, mesh erosion and constant, unremitting pain that left her unable to have sexual intercourse. Despite two subsequent surgeries, doctors have not been able to remove all the embedded, pain-causing mesh. After the verdict was announced, she spoke out for other women suffering from defective transvaginal mesh: “I am thankful for the jury’s verdict and hope my story can help other women who are suffering from mesh complications to receive the resolution they deserve. While difficult to share, I hope my case demonstrates to all mesh manufacturers the dangers of their products and the justice they owe victims.”

This is the largest verdict against any manufacturer in the mesh litigation. The largest verdict before this was $73.5 million awarded last year to a Texas woman against Boston Scientific over her Obtryx mesh sling. More than 70,000 mesh cases are pending in federal court in West Virginia, and more are pending in state courts in California, Delaware, Missouri, New Jersey, and Texas.

Thornton Law Firm’s transvaginal mesh attorneys represent women in claims against all the manufacturers of transvaginal mesh:  Boston Scientific Corp., Caldera, C.R. Bard, Inc., Ethicon (a subsidiary of Johnson & Johnson) and Sofradim/Covidien. If you have a transvaginal mesh implant and have suffered complications including mesh erosion, mesh contraction, pain, additional surgery, infection, bleeding, urinary problems, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation, for a free, confidential evaluation of your legal claim, please tell us your story here or call our toll free number 888-341-1405. Like all legal claims, defective mesh claims are subject to short, strictly enforced time limits. Do not delay seeking legal advice.

Four Reasons To Be Optimistic About Transvaginal Mesh Litigation

By Marilyn  T. McGoldrick, Esq.

Published on Aug 22, 2014

justice2Boston Scientific won a defense verdict in the first transvaginal mesh (TVM) case to go to trial in Middlesex Superior Court. The jury ruled that plaintiff Diane Albright had not proved that her Pinnacle vaginal mesh device was defectively designed, or that it lacked adequate warnings. While Boston Scientific won this round, we believe that there are four reasons to believe that TVM cases going forward will be won by the plaintiffs.

1. This plaintiff never had her mesh implant removed.

She hadn’t undergone revision surgery – the device was not removed from her body despite the pain it had caused her since implantation in 2010. One of the plaintiff’s attorneys, Jonathon D. Orent, commented “Ms. Albright’s doctors ultimately concluded that it would be more dangerous for her to have surgery to try and remove the mesh. I think the jury had difficulty in identifying with her injuries because of her doctors’ decision not to pursue aggressive surgery.”

2. This case was tried using Ohio law.

Because Ms. Albright lived in Ohio and had the Pinnacle mesh device surgically implanted in the state of Ohio, Ohio law controlled the result. The Ohio Product Liability Act, passed in 2005, requires a different, more difficult burden of proof than would be required under common law, and limits the theories under which a plaintiff can pursue a claim against a product manufacturer.

3. This plaintiff didn’t argue polyproplyene isn’t fit for human implantation

The plaintiff’s attorneys argued that the Pinnacle transvaginal mesh device was defective because it contained too much polypropylene, not that the polypropylene shouldn’t have been used at all. The plaintiffs’ lawyer’s decision to argue the case this way was likely because the plaintiff could not have the device removed.  Despite the fact that the decision not to remove the device was based on the advice of her doctors, jurors may have concluded that if it shouldn’t have been used at all, wouldn’t she have had it removed?

4. This was a case the defense picked.

Finally, this case was selected as a bellwether trial by Boston Scientific precisely because they believed it was a weak case that they could win. Other bellwether trials of cases selected by plaintiffs’ counsel will likely lead to very different outcomes.

Thornton Law Firm’s Drug and Medical Device lawyers represent women in transvaginal mesh claims against Boston Scientific Corp., as well as Caldera, C.R. Bard, Inc., Ethicon (subsidiary of Johnson & Johnson) and Sofradim/Covidien. If you have a transvaginal mesh implant and have suffered complications including pain, mesh erosion, mesh contraction, additional surgeries, urinary problems, severe pelvic pain, infection, bleeding, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation, and would like a free, confidential evaluation of your legal claim, please tell us your story here or call us at our toll free number 888-341-1405.

New Pretrial Orders Issued In Transvaginal Mesh MDL

By Marilyn T. McGoldrick, Esq.

Posted on June 19, 2013

Last week the West Virginia court overseeing the vaginal mesh litigation involving Johnson & Johnson’s Ethicon unit issued a pair of new pre-trial orders. The first rescheduled the presentation of possible bellwether cases to the court by one week, to July 25, 2013. The court will review the cases presented and decide which cases will be the first to go to trial, and in what order they will be tried. None of the other dates in the court’s pre-trial order were changed, so the first trial is still scheduled to be held on January 14, 2014 in front of Judge Joseph R. Goodwin.

The second new pre-trial order adopts a stipulation agreed to by both sides regarding documents produced in response to subpoenas to third parties. It gives Johnson & Johnson & Ethicon 30 days to review the documents and designate any portions as confidential or proprietary information. The plaintiffs will have copies of all the documents from the beginning including the 30 day period of confidentiality review. We believe this is a fair agreement and it will speed up the acquisition of the documents we believe will strengthen the plaintiffs’ cases.

Thornton Law Firm mesh lawyers continue to investigate transvaginal mesh claims against J&J and Ethicon, as well as against the other vaginal mesh manufacturers American Medical Systems, Inc., C.R. Bard, Inc., and Boston Scientific Corp. We offer free consultations. If you are one of the thousands of women who received painfully defective mesh implants, tell us your story here, or call us at 888-341-1405 to discuss your legal rights. Time limits for filing a claim are short so do not delay.

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