Enhanced safety in breast implants

Enhanced safety in breast implants

Introduction Despite significant improvements in implant quality, rupture of breast implants is still possible If leak is suspected: Detection by palpation Experienced plastic surgeon is less than 30% accurate (Iwuagwu et al.; Br. J. Plast. Surg.1997) 70% leakage missed Ultrasound 70% specific 30% leakage missed MRI 91 % specific: Current golden standard Still 9% leakage missed

Introduction FDA recommends MRI 3 years post implantation and biannually thereafter Substantial evidence current imaging is imperfect Thus: Candidates for breast augmentation are reluctant due to risks of leakage of implants Enhanced detection of possible rupture gives women confidence in implant quality

Why do breast implants leak? Envelope integrity declines, possibly due to infiltration of lipids Implant failure: aging, per-implantation damage, thoracic trauma, closed capsulotomy A minimum of 15% of modern implants must be expected to rupture between 3 rd and 10 th year after implantation (Holmich et al.; Archives of Surgery 138, 801-6 (2003))

Introduction After 10-15 years of implantation rupture rate increases rapidly. Robinson et al.: 71 % of 300 explantees have time-dependent disruption of one or both implants Also, after implantation impact to implants can occur. Women often seek confirmation that the implant is still intact Detection method should be 100% conclusive Readily available in every hospital Fast Cost effective

The invention The basis of our invention is the use of relatively large contrast particles, which are dispersed homogenously in the cohesive gel of the breast prosthesis Particles are evenly distributed in crosslinked silicone gel and can not move through gel (confirmed by >10G spinning) Easy to implement in production process

The invention The particles can be made visible on: MRI and/or X-ray and/or CT and/or Ultrasound Particles can be seen individually Particles can have different shapes (mass: 0.25-0.50 g; volume: 0.3-0.6 μl) Can easily be differentiated from other radiological conditions (eg. breast cancer)

The invention Particles are composed of Pebax with well-established biocompatibility (eg. pacemaker leads) Contrast agent is dispersed in each particle. The actual contrast agent can be: MRI: ferromagnetic iron, paramagnetic iron X-ray: BaSO 4 Ultrasound: Hollow gas-filled particles The use of Pebax to contain the contrast agents is our key novum, and it is an important safety issue The presence of the particles in the gel does not influence the gel s softness or other rheological parameters

Intact and leaking implant with Pebax particles

The invention Implant failure: Cohesive gel and particles leak ouside envelope, Pebax/contrast particles will be located outside the envelope 100% MRI and/or X-ray and/or CT and/or ultrasound visible No false positive of false negative results No more missing of 9% false negative leaking implants (MRI: current gold standard)

Experiment Two breast prostheses were filled with a cohesive gel + Pebax particles dispersed therein. The particles contained 5% (by mass) bariumsulfate, which rendered them visible on CT images, NOT on MRI The prostheses were implanted in a porcine cadaver following a routine surgical protocol One of the prostheses was artificially damaged at and some of the gel (+ particles) was forced out of the envelope MRI and CT images were made It could be established clearly that one implant was intact, while the other was leaking

Implantation in porcine cadaver model Breast implant with the contrast particles (blue) dispersed in the gel. Here, the intact implant is inserted into the porcine cadaver model

CT vs. MRI CT MRI Doubtful leaking on MRI (right, red arrow) clearly visible on CT (left, blue arrow)

CT MRI Representative plot from CT imaging, showing the two breast implants. Contrast particles inside both envelopes (left) are clearly visible. Some contrast particles are seen outside the envelope of the left implant (blue arrow), revealing the leak made in this breast implant Leaking of content is more elaborate than visible on MRI (right, red arrow)

Implications for marketing Patients demand safest implant from their surgeon Surgeons and implant manufacturer want safest implants for their clients Patient satisfaction Medicolegal aspects Improved safety of implant increases quality difference to other brands

Implications for marketing Unique selling point Owner of patent will increase market share Owner of patent will increase patient satisfaction product quality production numbers of implants company profits

Conclusions Leaking of implant now 100% detectable Cost effective and fast detection Enhanced patient confidence in product Easy to implement in production process 100% safety of implant is unique selling point

(WO/2010/047587) I MPLANT FOR PROSTHESES Patent Latest bibliographic data on file with the International Bureau Pub. No.: WO/2010/047587 International Application No.: PCT/NL2009/050632 Publication Date: 29.04.2010 International Filing Date: 20.10.2009 IPC: A61L 27/50 (2006.01), A61L 31/10 (2006.01) Applicants: Inventors: Agent: HACTA B.V. [NL/NL]; Bolderik 9 NL-6271 EC Gulpen (NL) (All Except US). KOOLE, Levinus Hendrik [NL/NL]; (NL) (US Only). DUMONT, Ewald Anna Wilhelmus Jozef [NL/NL]; (NL) (US Only). DUMEDIC B.V. [NL/NL]; Levignelunet 11 C 6221 KM Maastricht (NL) (All Except US). KOOLE, Levinus Hendrik; (NL). DUMONT, Ewald Anna Wilhelmus Jozef; (NL). HATZMANN, M.J.; Vereenigde Johan de Wittlaan 7 NL-2517 JR Den Haag (NL). Priority Data: 08167030.9 20.10.2008 EP Title: Abstract: Designated States: IMPLANT FOR PROSTHESES The invention is directed to an implant comprising an envelope filled with a core filling material, such as breast implants and implants for aesthetic and reconstructive surgery, comprising at least one biocompatible gel material and evenly dispersed through the gel material at least one particulate radiopaque, MRI and/or ultra- sound visible material, wherein the core filling material is viscoelastic at 37 C, having a viscosity in the range of 10 to 108 cp. AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. African Regional Intellectual Property Org. (ARIPO) (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW) Eurasian Patent Organization (EAPO) (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM) European Patent Office (EPO) (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, TR) African Intellectual Property Organization (OAPI) (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).