Case guide

Boston Scientific mesh: which repair did you have?

FDA reviewed Boston Scientific mesh for vaginal POP repair after sales stopped. Slings have a different use.

See If You Qualify

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Updated Oct 4, 202614 sources

This may apply to you if

  • Prepare the mesh name, reason for repair and route used.
  • List symptoms, later care and the dates you know.
  • Bring any old claim or deal papers; ask a lawyer about your route.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

U.S. Food and Drug Administration · Publisher of the dated POP mesh review and stop-sale record

Finding: In its October 2022 POP review entry, FDA kept an unfavorable benefit-risk assessment for vaginal prolapse mesh because of added exposure and erosion risks. That assessment is distinct from its sling review and from a diagnosis in any one patient.

FDA: dated POP and sling review activities (opens in a new tab) · Oct 17, 2022 · Checked Oct 3, 2026

The evidence and its limits

United States Food and Drug Administration · 2022

FDA 2021/2022 final reviews of transvaginal prolapse mesh follow-up

Design:
Agency review
Participants:
Agency reviews of separate manufacturer studies; no combined participant total supplied on this page
Finding:
Similar outcomes to own-tissue repair at 36 months, but added exposure/erosion risks led FDA to maintain an unfavorable benefit-risk finding for vaginal POP mesh.
Main limitation
Specific POP devices and 36-month follow-up; not bladder slings or abdominal repair. No individual harm rate; underlying full reports not independently read.

Read the source: FDA 2021/2022 final reviews of transvaginal prolapse mesh follow-up (opens in a new tab) · Checked Oct 3, 2026

The short answer

Which Boston Scientific products did FDA review for POP?
The August 2021 entry names Uphold Lite and Xenform. They were used for vaginal prolapse repair. That review is distinct from urine-leakage slings. [1]
What did that POP review find?
At 36 months, results were like those for repair without mesh. FDA still found added risks of exposed mesh. It kept its view that the risks outweighed benefits for this use. [1]
Are Boston Scientific slings the same products?
A urinary sling treats urine leakage. It is a different use from vaginal POP mesh. Ask which product and operation are in your chart. [3]
What should I ask about symptoms after repair?
Describe ongoing bleeding, unusual fluid or pain. Ask what the clinician has confirmed. The product name alone cannot diagnose the cause. [2]

What rules a case out

Not covered by this case

  • A general finding does not decide the cause of your own harm.
  • These dated records do not decide a personal claim or care plan.

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

FDA reviewed Boston Scientific mesh for vaginal POP repair after sales stopped. Slings have a different use. Check the product and what your surgery treated.

Which Boston Scientific products did FDA review for POP?

The August 2021 entry names Uphold Lite and Xenform. They were used for vaginal prolapse repair. That review is distinct from urine-leakage slings.

The FDA entry says the products were no longer commercially available, but enrolled patients continued follow-up. The April 2019 action had rejected approval applications for the remaining vaginal POP products. A manufacturer name alone does not show which review applies to your operation.

What did that POP review find?

At 36 months, results were like those for repair without mesh. FDA still found added risks of exposed mesh. It kept its view that the risks outweighed benefits for this use.

Those conclusions come from the agency’s review of the two manufacturer study reports. They are not a pooled patient count, a lifelong outcome or proof of the cause of your symptoms. The agency summary does not identify the cause of one patient’s harm.

Are Boston Scientific slings the same products?

A urinary sling treats urine leakage. It is a different use from vaginal POP mesh. Ask which product and operation are in your chart.

FDA’s sling page links a Solyx mini-sling study and compares mini-slings with traditional slings. Its review found comparable performance over the studied follow-up, not absence of risk. Do not apply the 2019 POP stop-sale action to every sling solely because the maker is the same.

What should I ask about symptoms after repair?

Describe ongoing bleeding, unusual fluid or pain. Ask what the clinician has confirmed. The product name alone cannot diagnose the cause.

Tell the provider whether you had POP repair, a sling or both. FDA recommends routine follow-up for people satisfied with surgery and without symptoms. Discuss care or a specialist second opinion when concerns persist rather than assuming removal is required.

What does the court history say about a Boston claim?

The court report lists Boston’s pelvic repair group, numbered 2326. It gives 2021 as the year it ended. That does not show your payment or outcome.

The report treats Boston Scientific separately from Bard and Ethicon. It does not supply a current case count, payment average or new-claim acceptance rule. If you have a filed case, ask counsel which court and later orders now apply.

Which records help distinguish my Boston product?

Ask for the surgery note and product papers. Check why and how the repair was done. Add later care and any case papers.

Keep a sling’s records separate from those of prolapse mesh placed at the same operation. If the product remains unknown, state that gap clearly. A lawyer can review the correct device and law without treating a brand-level webpage as a personal qualification or deadline decision.

Find out where you stand.

The review is free and private. Asking for it doesn’t commit you to anything.

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Sources

  1. FDA mesh activities: POP stop-sale and later reviewsFDA mesh activities: POP stop-sale and later reviews · regulator
  2. FDA patient information: pelvic organ prolapseFDA patient information: pelvic organ prolapse · regulator
  3. FDA patient information: stress urinary incontinenceFDA patient information: stress urinary incontinence · regulator
  4. FDA guidance: vaginal versus abdominal prolapse meshFDA guidance: vaginal versus abdominal prolapse mesh · regulator
  5. FDA review: mini-slings for stress urinary incontinenceFDA review: mini-slings for stress urinary incontinence · regulator
  6. PROSPECT original four- and six-year randomized follow-upPROSPECT original four- and six-year randomized follow-up · study
  7. Ethicon MDL2327 Pretrial Order337, entered May1,2019Ethicon MDL2327 Pretrial Order337, entered May1,2019 · court
  8. Southern District of West Virginia: Ethicon MDL2327 public archiveSouthern District of West Virginia: Ethicon MDL2327 public archive · court
  9. JPML cumulative terminated litigations through September30,2025JPML cumulative terminated litigations through September30,2025 · court
  10. New Jersey courts: Pelvic Mesh/Gynecare dated orders indexNew Jersey courts: Pelvic Mesh/Gynecare dated orders index · court
  11. ABA Model Rule1.5: feesABA Model Rule1.5: fees
  12. HHS individual access to health informationHHS individual access to health information · regulator
  13. SDNY: how long to file a complaintSDNY: how long to file a complaint · court
  14. US Courts: civil casesUS Courts: civil cases · court

Checked against 14 primary sources by People's Justice editors · Updated

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