Johnson & Johnson Prolift Vaginal Mesh: $80M Verdict in Latest Trial

By Marilyn T.  McGoldrick, Esq.

Published on May 28, 2019

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A Philadelphia jury ordered Ethicon, a subsidiary of Johnson and Johnson, to pay $80 million dollars to a woman who was injured by her Prolift transvaginal mesh implant. The verdict included an award of $50 million dollars in punitive damages. This is the 10th mesh-related case tried in Philadelphia and the 8th verdict in favor of plaintiffs.

Patricia Mesigian was implanted with Ethicon’s Prolift mesh in 2008 when she was 64. The implant was intended to treat her pelvic organ prolapse, a condition where the muscles supporting the organs weaken allowing the organs to drop down and press on or into the vagina. Instead of treating her condition, the implant caused her vaginal bleeding and pain, discomfort during sex, infection, and inflammation. Eventually the mesh eroded into her vagina and she endured 5 surgeries and two chemical burn treatments in an attempt to remove the mesh which was embedded in scar tissue.

The jury deliberated two days before reaching its verdict. They found the Prolift implant was defective and that the defendants failed to adequately describe the risks.  The jury awarded Ms. Mesigian $30 million in compensatory damages.

This is the second verdict against Ethicon in less than one month. An Altoona woman was awarded $120 million in April for the defective mesh she was implanted with to treat urinary incontinence. The verdict comes in the wake of the FDA’s decision to ban the last two manufacturers of pelvic mesh, Boston Scientific and Coloplast, from selling or distributing mesh products for transvaginal repair of pelvic organ prolapse in the United States. The FDA said that the manufacturers were unable to show that the products were safe or effective for the treatment of organ prolapse, compared to repair procedure using native tissues. Johnson & Johnson’s Ethicon unit stopped selling the Prolift transvaginal mesh implants in 2012.

J&J’s Ethicon issued a statement saying that the verdict was “inconsistent with the science” and that they plan to appeal.

Any woman who has mesh implanted to treat pelvic organ prolapse who is having any symptoms connected with the implant should contact her doctor immediately. The injuries caused by defective transvaginal mesh may include vaginal bleeding or discharge, severe pelvic or groin pain, infection, pain during sexual intercourse, urinary problems, or perforated organs from mesh eroding into surrounding tissues. Do not delay seeking medical attention if you have any symptoms you believe are related to your transvaginal mesh implant.

If you would like to explore your legal options regarding your mesh implant, call the transvaginal mesh lawyers at Thornton Law Firm at 888-491-9726 to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your claim.

 

 

 

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.

Pelvic Mesh for POP Reclassified as “High-Risk” Device


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.

Transvaginally implanted mesh to treat POP now classified as high-risk

The FDA has issued a final order reclassifying transvaginal mesh used to repair Pelvic Organ Prolapse (POP) from class II (moderate-risk) to class III (high-risk). The FDA will also require manufacturers of every surgical mesh used to treat POP to conduct a PreMarket Approval application demonstrating the safety and effectiveness of their mesh product for treating POP. Manufacturers have 30 months — two and one half years — to show that their products are safe and effective for POP. These new FDA orders do not apply to mesh sold for Stress Urinary Incontinence (SUI) or abdominal repair.

FDA regulation of pelvic mesh

The first mesh device for POP was approved by the FDA in 2002 . In 2008 the FDA issued a Public Health Notification of what it called “rare” complications — after receiving 1,000 reports of complications from device manufacturers. In July of 2011 the FDA issued a Safety Communication to warn doctors and patients that complications from pelvic mesh were not rare; instead, their own analysis showed that a) 10% of patients who underwent surgery with pelvic mesh suffered mesh erosion within 12 months of surgery and b) mesh used in POP repair does not “conclusively improve clinical outcomes over traditional non-mesh repair.” An advisory panel on pelvic mesh appointed in July 2011 recommended the FDA collect more data; in 2012 the agency ordered manufacturers to conduct post-market surveillance studies

History of transvaginal mesh use

Surgical mesh has been used in surgeries since the 1950s. Gynecologists began using pelvic mesh transvaginally for POP in 1992. The first mesh device sold to treat POP was approved by the FDA in 2002 as a Class II moderate-risk device using the 510(k) process. The manufacturer represented to the FDA that the device was substantially equivalent, just as safe and effective, as a device already on the market. The new FDA orders are a recognition that that claim of substantial equivalence was wrong. Thousands of complaints from women who suffered adverse effects from mesh have been reported to the FDA, including pain, bleeding, mesh contraction, mesh erosion, infection, urinary problems, severe pelvic pain, vaginal tightening or shortening, additional surgeries, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation. These significant risks must be addressed by manufacturers in their applications for approval.

How is mesh used to treat POP?

Pelvic organ prolapse (POP) is a common medical condition in older women, especially in women who have had children. The internal structure that supports the bladder, uterus, bowel and other pelvic organs becomes so weak, stretched or torn that those organs can drop from their normal position and prolapse (bulge) into the vagina. POP isn’t life threatening, but it causes a host of problems that may include pelvic pressure or low back pain, painful sexual intercourse, constipation, and urine leakage or a chronic urge to urinate. The more common method of implanting mesh is through the vagina as it is less invasive than implantation through the abdomen. The most common side effects of using mesh transvaginally include “severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.”

How many women will need POP?

The numbers of women affected by POP are staggering. 200,000 women undergo pelvic organ prolapse surgery every year. It is the most common inpatient procedure performed on women over the age of 70. In addition, at least 135,000 personal injury lawsuits are pending against the manufacturers of surgical mesh. The personal injury lawsuit number includes pelvic mesh used in Stress Urinary Incontinence (SUI) and other abdominal surgeries; those products are not covered by these new FDA orders, which apply only to mesh devices to treat POP.

What can you do if you have defective pelvic mesh?

Women who experience any of the symptoms we’ve discussed in this post should consult their doctor. If you have suffered complications from a transvaginal mesh implant, call 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 for a completely confidential evaluation of your legal rights. Time limits for filing claims are short, so contact an attorney as soon as possible.

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