Restella R20153-2020GRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09421905067034), received between Dec 4, 2019 and Dec 4, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A BILATERAL MASTECTOMY WITH IMMEDIATE PREPECTORAL DIRECT TO IMPLANT BREAST RECONSTRUCTION ON (B)(6) 2019. THE IMPLANTS WERE ANTERIORLY COVERED WITH RESTELLA RESORBABLE (PGA). ON (B)(6) 2019 (13 DAYS POST OP), THE PATIENT PRESENTED WITH AN ESCHAR AT THE RIGHT BREAST INCISION LINE. THE SURGEON PLANNED STANDARD EXCISION AND IRRIGATION BUT UPON OPENING THE INCISION HE ENCOUNTERED SOME FLUID AND NOT YET INCORPORATED RESTELLA RESORBABLE. AS A PRECAUTION, THE SURGEON REMOVED THE BREAST IMPLANT AND REMAINING RESTELLA RESORBABLE ON THE RIGHT SIDE. THE LEFT SIDE REMAINED INTACT.

  Patient problems: Wound Dehiscence

  MAUDE report 9413542 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A BILATERAL MASTECTOMY WITH IMMEDIATE PREPECTORAL TISSUE EXPANDER BREAST RECONSTRUCTION ON (B)(6) 2019. THE PATIENT DRAINED APPROXIMATELY 100CC/DAY OF CLEAR SEROUS DRAINAGE ON EACH SIDE AND WAS TAKEN BACK TO THE OR ON (B)(6) 2019 (12 DAYS POST OP) FOR EXPLORATORY SURGERY. INCORPORATION OF THE RESTELLA RESORBABLE (PGA) HAD BEGUN AT THE ATTACHMENT TO THE MUSCLE BUT WAS NOT YET COMPLETE. AS A PRECAUTION, THE SURGEON REMOVED THE IMPLANTS ON BOTH SIDES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9413541 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WHO HAD UNDERGONE A BILATERAL MASTECTOMY DUE TO BREAST CANCER UNDERWENT A PREPECTORAL BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND RESTELLA RESORBABLE (PGA) ON (B)(6) 2019. THE EXPANDERS WERE ANTERIORLY COVERED WITH RESTELLA RESORBABLE. THE PATIENT'S LEFT EXPANDER DEFLATED AND SHE WAS BROUGHT BACK FOR RE-OPERATION ON (B)(6) 2019 (42 DAYS POST-OP) TO REPLACE THE EXPANDER. AT THE TIME OF REOPERATION, IT WAS NOTED THAT THE RESTELLA RESORBABLE WAS STILL IN THE PROCESS OF INCORPORATING. AS A PRECAUTION, THE SURGEON REMOVED SOME UNINCORPORATED PORTIONS OF THE RESTELLA RESORBABLE DEVICE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9413537 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A BILATERAL MASTECTOMY WITH IMMEDIATE DIRECT TO IMPLANT PREPECTORAL BREAST RECONSTRUCTION ON (B)(6) 2019. THE BREAST IMPLANTS WERE ANTERIORLY COVERED WITH RESTELLA RESORBABLE (PGA). THE PATIENT EXHIBITED DRAINAGE OF OPAQUE FLUID ON BOTH SIDES. SWELLING AND REDNESS DEVELOPED, FIRST ON THE RIGHT BREAST ON (B)(6) 2019 (32 DAYS POST OP) ON THE LOWER POLE. AS A PRECAUTION THE PATIENT WAS TAKEN TO THE OR AND THE RIGHT BREAST IMPLANT AND RESTELLA RESORBABLE WERE REMOVED. THREE DAYS LATER THE SURGEON NOTICED A SIMILAR PATTERN ON THE LEFT BREAST. THE PATIENT RETURNED TO THE OR THAT DAY AND THE LEFT BREAST IMPLANT AND RESTELLA RESORBABLE WERE REMOVED.

  Patient problems: Seroma

  MAUDE report 9413524 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SEE INITIAL MDR REPORT

  Patient problems: Wound Dehiscence

  MAUDE report 9413523 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A BILATERAL MASTECTOMY WITH IMMEDIATE PREPECTORAL TISSUE EXPANDER RECONSTRUCTION ON (B)(6) 2019. THE EXPANDERS WERE ANTERIORLY COVERED WITH RESTELLA RESORBABLE (PGA). THE PATIENT PRESENTED WITH AN INFECTED (S. LUGDUNESIS) SEROMA IN THE LEFT BREAST AND THE LEFT EXPANDER AND RESTELLA RESORBABLE WERE REMOVED ON (B)(6) 2019 (39 DAYS POST OP). THE RIGHT SIDE REMAINED INTACT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9413521 ↗