Limits...
Soft, Brown Rupture: Clinical Signs and Symptoms Associated with Ruptured PIP Breast Implants.

Godwin Y, Duncan RT, Feig C, Reintals M, Hill S - Plast Reconstr Surg Glob Open (2014)

Bottom Line: Acquired asymmetry (P = 0.0003), breast enlargement (P = 0.0002), fuller lower pole (P < 0.0001), and loss of lateral projection (P < 0.0001) were all significantly predictive of device failure.The lack of palpable and visible preoperative capsular contracture could be secondary to the elastic nature of the capsular tissue found.Analysis of brown gel revealed the presence of iodine, suggesting povidone iodine ingression at implantation.

View Article: PubMed Central - PubMed

Affiliation: Department of Plastic and Reconstructive Surgery, Morriston Hospital, Morriston, Swansea, United Kingdom; University of Cambridge, CRUK-Cambridge Institute, Robinson Way, Cambridge, United Kingdom; Dr Jones and Partners Medical Imaging, Adelaide, South Australia; and Science & Innovation, LGC, Teddington, Middlesex, United Kingdom.

ABSTRACT

Background: Preoperative signs and symptoms of patients with Poly Implant Prothese (PIP) implants could be predictive of device failure. Based on clinical observation and intraoperative findings 4 hypotheses were raised: (1) Preoperative clinical signs including acquired asymmetry, breast enlargement, fullness of the lower pole, decreased mound projection, and change in breast consistency could be indicative of implant rupture. (2) Device failure correlates with a low preoperative Baker grade of capsule. (3) Brown-stained implants are more prone to implant failure. (4) The brown gel could be indicative of iodine ingression through a substandard elastomer shell.

Methods: Preoperative clinical signs were compared with intraoperative findings for 27 patients undergoing PIP implant explantation.

Results: Acquired asymmetry (P = 0.0003), breast enlargement (P = 0.0002), fuller lower pole (P < 0.0001), and loss of lateral projection (P < 0.0001) were all significantly predictive of device failure. Capsule Baker grade was lower preoperatively for ruptured implants. The lack of palpable and visible preoperative capsular contracture could be secondary to the elastic nature of the capsular tissue found. Brown implants failed significantly more often than white implants. Analysis of brown gel revealed the presence of iodine, suggesting povidone iodine ingression at implantation.

Conclusions: Preoperative signs can be predictive of PIP implant failure. Brown-stained implants are more prone to rupture. The presence of iodine in the gel suggests unacceptable permeability of the shell early in the implant's life span. A noninvasive screening test to detect brown implants in situ could help identify implants at risk of failure in those who elect to keep their implants.

No MeSH data available.


Related in: MedlinePlus

A, Appearance of an intraoperative capsule. B, Digital pressure demonstrates the pliable, elastic nature of the capsule. No calcification is present.
© Copyright Policy
Related In: Results  -  Collection


getmorefigures.php?uid=PMC4255892&req=5

Figure 5: A, Appearance of an intraoperative capsule. B, Digital pressure demonstrates the pliable, elastic nature of the capsule. No calcification is present.

Mentions: Supplemental Digital Content 2 (http://links.lww.com/PRSGO/A57) compares preoperative signs recorded by the surgeon with the intraoperative findings in the 10 patients with ruptured implants. Rupture was bilateral in 2 patients and unilateral in 8 patients. Twelve of the 54 implants removed showed macroscopic rupture. In 10 of 12 implants, the elastomer shell had completely disintegrated (Fig. 4). Two implants exhibited minor tears. Palpable axillary lymphadenopathy was confirmed by the surgeon preoperatively in 6 patients with ruptured implants. Only 3 patients were aware of their lymphadenopathy. At least 2 out of the 5 clinical signs of soft rupture were present in all patients with proven implant rupture (on average, 4 signs per patient). The majority of ruptured implants demonstrated brown staining (10 of 12). The surgeon noted breast asymmetry and loss of project in the majority of patients with ruptured implants. Intraoperative capsule thickness was described most commonly as “mild.” All intraoperative capsules were pliable and elastic (Fig. 5), with no cases of capsular calcification.


Soft, Brown Rupture: Clinical Signs and Symptoms Associated with Ruptured PIP Breast Implants.

Godwin Y, Duncan RT, Feig C, Reintals M, Hill S - Plast Reconstr Surg Glob Open (2014)

A, Appearance of an intraoperative capsule. B, Digital pressure demonstrates the pliable, elastic nature of the capsule. No calcification is present.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4255892&req=5

Figure 5: A, Appearance of an intraoperative capsule. B, Digital pressure demonstrates the pliable, elastic nature of the capsule. No calcification is present.
Mentions: Supplemental Digital Content 2 (http://links.lww.com/PRSGO/A57) compares preoperative signs recorded by the surgeon with the intraoperative findings in the 10 patients with ruptured implants. Rupture was bilateral in 2 patients and unilateral in 8 patients. Twelve of the 54 implants removed showed macroscopic rupture. In 10 of 12 implants, the elastomer shell had completely disintegrated (Fig. 4). Two implants exhibited minor tears. Palpable axillary lymphadenopathy was confirmed by the surgeon preoperatively in 6 patients with ruptured implants. Only 3 patients were aware of their lymphadenopathy. At least 2 out of the 5 clinical signs of soft rupture were present in all patients with proven implant rupture (on average, 4 signs per patient). The majority of ruptured implants demonstrated brown staining (10 of 12). The surgeon noted breast asymmetry and loss of project in the majority of patients with ruptured implants. Intraoperative capsule thickness was described most commonly as “mild.” All intraoperative capsules were pliable and elastic (Fig. 5), with no cases of capsular calcification.

Bottom Line: Acquired asymmetry (P = 0.0003), breast enlargement (P = 0.0002), fuller lower pole (P < 0.0001), and loss of lateral projection (P < 0.0001) were all significantly predictive of device failure.The lack of palpable and visible preoperative capsular contracture could be secondary to the elastic nature of the capsular tissue found.Analysis of brown gel revealed the presence of iodine, suggesting povidone iodine ingression at implantation.

View Article: PubMed Central - PubMed

Affiliation: Department of Plastic and Reconstructive Surgery, Morriston Hospital, Morriston, Swansea, United Kingdom; University of Cambridge, CRUK-Cambridge Institute, Robinson Way, Cambridge, United Kingdom; Dr Jones and Partners Medical Imaging, Adelaide, South Australia; and Science & Innovation, LGC, Teddington, Middlesex, United Kingdom.

ABSTRACT

Background: Preoperative signs and symptoms of patients with Poly Implant Prothese (PIP) implants could be predictive of device failure. Based on clinical observation and intraoperative findings 4 hypotheses were raised: (1) Preoperative clinical signs including acquired asymmetry, breast enlargement, fullness of the lower pole, decreased mound projection, and change in breast consistency could be indicative of implant rupture. (2) Device failure correlates with a low preoperative Baker grade of capsule. (3) Brown-stained implants are more prone to implant failure. (4) The brown gel could be indicative of iodine ingression through a substandard elastomer shell.

Methods: Preoperative clinical signs were compared with intraoperative findings for 27 patients undergoing PIP implant explantation.

Results: Acquired asymmetry (P = 0.0003), breast enlargement (P = 0.0002), fuller lower pole (P < 0.0001), and loss of lateral projection (P < 0.0001) were all significantly predictive of device failure. Capsule Baker grade was lower preoperatively for ruptured implants. The lack of palpable and visible preoperative capsular contracture could be secondary to the elastic nature of the capsular tissue found. Brown implants failed significantly more often than white implants. Analysis of brown gel revealed the presence of iodine, suggesting povidone iodine ingression at implantation.

Conclusions: Preoperative signs can be predictive of PIP implant failure. Brown-stained implants are more prone to rupture. The presence of iodine in the gel suggests unacceptable permeability of the shell early in the implant's life span. A noninvasive screening test to detect brown implants in situ could help identify implants at risk of failure in those who elect to keep their implants.

No MeSH data available.


Related in: MedlinePlus