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Related Concept Videos

Bioequivalence studies: Biowaivers01:13

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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Results from the MemoryGel Post-approval Study.

Kimberly K Short1, Roger N Wixtrom2, Megan M Estes3

  • 1The Gillian Institute, Indianapolis, Ind.

Plastic and Reconstructive Surgery. Global Open
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This summary is machine-generated.

The 10-year MemoryGel Post-Approval Study found no new significant risks with MemoryGel Breast Implants. Re-operation and explantation rates varied by initial procedure type, with reconstruction patients showing higher rates.

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Area of Science:

  • Medical Device Studies
  • Plastic Surgery Research
  • Long-term Patient Outcomes

Background:

  • Mentor MemoryGel Breast Implants received conditional approval in 2006.
  • A 10-year post-approval study was mandated to assess long-term safety in US women.

Purpose of the Study:

  • To evaluate long-term experience and safety of MemoryGel Breast Implants.
  • To assess rheumatologic and neurologic signs/symptoms (initially).
  • To collect re-operation data for MemoryGel participants.

Main Methods:

  • Prospective, observational 10-year follow-up study with a concurrent cohort design.
  • Included MemoryGel Breast Implant and saline control groups.
  • Protocol amended in 2015 to focus on re-operation data.

Main Results:

  • Kaplan-Meier 10-year cumulative incidence for re-operation ranged from 10.5% (primary augmentation) to 25.0% (revision reconstruction).
  • 10-year cumulative incidence for explantation ranged from 4.2% (primary augmentation) to 16.6% (revision reconstruction).
  • Reasons for re-operation were documented.

Conclusions:

  • The Re-operation Phase assessed implant removal and re-operation rates.
  • No significant new hazards, increased risks, or unexpected adverse events were identified.
  • Study provides insights into reasons for re-operation over time.