For a specified health benefit, a surgically implanted medical gadget is maintained inside a patient for a set period of time. Transvaginal mesh devices are one kind of surgically implanted medical device.
Thousands of women who had transvaginal mesh implants to address stress urinary incontinence and pelvic organ prolapse claim that the devices caused them to experience excruciating agony, organ damage, and other issues.
At least 20 judgments totaling around $300 million have been awarded to transvaginal mesh plaintiffs in state and federal courts since 2012. By March 2017, numerous businesses had paid out millions to resolve thousands of claims.
Patients have successfully sued manufacturers for millions of dollars. For instance, a jury in 2018 gave Mary McGinnis and her husband a $68 million verdict. In 2019, a different jury gave Patricia Mesigian an award of $80 million.
The MDLs have received 108,008 lawsuits in all. However, the number of lawsuits that are currently ongoing has decreased as a result of waves of settlements.
2,263 cases were pending against four implant manufacturers as of November 2019 in West Virginia’s multidistrict litigation (MDL). The most lawsuits of any manufacturer were filed against Johnson & Johnson’s Ethicon division (1,202), followed by Boston Scientific (965), American Medical (80), and Bard (16).
The FDA halted mesh sales for POP in 2019 because the producers could not demonstrate that the advantages outweighed the hazards.
Transvaginal Mesh: What Is It?
In reality, the term “transvaginal mesh” refers to the surgical procedure doctors employ to implant the mesh through a woman’s vagina. Plastic material called polypropylene is used to create the mesh. The abdomen or vagina is used to introduce the plastic mesh.
How Is the Mesh Used?
The device was developed to fix pelvic organ prolapse or stress urinary incontinence permanently. When the pelvic muscles deteriorate, the bladder, uterus, and rectum can drop into the vaginal area, resulting in the latter syndrome.
Both diseases can develop during the following:
- Childbirth
- Hysterectomy
- Menopause
What Consequences Can a Transvaginal Mesh Cause?
A woman’s organs and vaginal walls can deteriorate within a few weeks or months following surgery. Other negative effects include:
- Acute pain
- Dyspareunia, or uncomfortable sexual activity
- Urinary incontinence returning
- Continent pain
- Pelvic pain
- Restricting some actions like sitting and walking
- Infections
- Organ piercing
Are Mesh Devices Available in a Variety of Types?
Although transvaginal mesh is the most widely utilized mesh product, other mesh products can also be applied. These mesh gadgets consist of the following:
- Mini-slings
- Tape for trans-obturation
- Transvaginal tape that isn’t tense
Do I Have a Claim for a Defective Product if I Underwent Surgery with Transvaginal Mesh?
A woman who has had transvaginal mesh surgery may be able to file a claim for a faulty product. A defective product is any kind of product that harms a person as a result of:
- Design flaw
- Manufacturing flaw
- Marketing mistake
Is a Lawsuit for a Defective Product the Same as a Lawsuit for Medical Malpractice?
No. Medical malpractice refers to carelessness on the part of a doctor or surgeon, for example. The medical attention or treatment level fell short of what was necessary.
Multidistrict ObTape Litigation
The initial transvaginal mesh litigation used a product called ObTape made by Mentor before the Judicial Panel on Multidistrict Litigation established the main mesh MDL in West Virginia.
Multidistrict litigation involving several of these cases was created in 2008 by the judicial panel.
Between 2008 and 2017, 857 lawsuits in total were involved in this MDL.
The judge in charge of the MDL requested in 2016 that the judicial panel halt adding cases to the ObTape MDL. He claimed that too many lawsuits that had sufficient support in court and cases that had missed the deadline for filing lawsuits had been filed in the MDL.
The judging panel has not concluded the ObTape MDL. State courts continue to accept claims from women seeking compensation for ObTape harms.
Damages Include Pain, Infection, and Erosion
Women who received the device, which is used to treat stress urinary incontinence, or SUI, claimed they experienced terrible injuries.
According to lawsuits, these women had difficulties sitting, walking, having intercourse, and engaging in other activities. Many women were forced to endure numerous revision operations to remove the implants because the problems were so severe.
Among the issues raised in litigation are:
Erosion
Implants that harm internal organs or vaginal walls cause this.
Bacteria can grow on implants and result in illnesses, according to studies on infection.
Pain
The gadget may cause scars and pain, including painful sex, by injuring nerves, slicing through tissues, or shrinking.
Urinary Issues
The gadgets could obstruct the bladder, which would make it challenging to urinate.
Persistent Prolapse
The implant may malfunction even after mesh surgery, leading to recurrent prolapse.
Continual Incontinence
Some women have bladder or rectum incontinence that is either new or worsens with time.
Charges Leveled Against Manufacturers
Women who filed complaints contend that while manufacturers “had a legal duty to ensure the safety and effectiveness of their pelvic mesh systems,” they instead gave patients “false and misleading information” about the products’ purported safety and efficacy. According to a 2017 report published in BMJ, the products’ approval for usage was based on “poor evidence.”
Lawsuits accuse mesh producers of:
- Intentionally misrepresenting the products’ actual safety and efficacy to the U.S. Food and Drug Administration, the medical profession, patients, and the general public.
- Failing to test devices adequately.
- Failing to investigate the products’ hazards.
- Failing to develop efficient removal techniques for the materials
- Not sufficiently alerting individuals to potential problems and harm.
Verdicts and Settlements
Manufacturers have already paid out billions of dollars in settlements and jury awards. According to the New York Times, 32 women had been tried in federal or state court as of February 2019. Of those women, 24 got jury verdicts worth a combined $345 million, while mesh makers have made settlement payments totaling almost $8 billion.
Case Decisions
The MDL court has asked J&J, Bard, and Boston Scientific to settle additional litigation because each of them lost several bellwether trials. J&J has kept up its legal defense despite agreeing to pay $120 million to resolve 2,000 to 3,000 cases in 2016.
In the case of Christine Scott, the first significant mesh verdict was rendered in July 2012. A jury in California gave her a $5.5 million judgment against C.R. Bard. Since then, the plaintiffs have won a number of verdicts.
Before going to trial, some businesses reached confidential settlements.
Class Action
A device manufacturer’s insurance carrier, Caldera Medical Inc., launched a class-action lawsuit against its client in 2015 over a coverage issue. 2,184 claims from women who claimed to have been injured by the items led Federal Insurance Co. to sue Caldera.
The firms put aside an $11.75 million settlement fund for these claimants in 2016. Judge Stephen Wilson of the U.S. District Court authorized the settlement on March 3, 2017, at a total cost of $12.25 million. Wilson stated in his ruling that the settlement “is made in good faith; and is fair, reasonable, adequate, and consistent with due process.”
Does My Lawsuit Need an Attorney’s Assistance?
Yes. Because the basis of the case is that the transvaginal mesh is faulty, it can be challenging to establish this. Contact a defective products lawyer to get legal help with your claim for defective items.
