A listing of Breast Implants medical research trials actively recruiting patient volunteers. Search for closest city to find more detailed information on a research study in your area. Lotus Clinical Research is conducting a research study to evaluate the safety of an investigational pain medication in patients following breast augmentation surgery.
Subjects, whose body shape is suited to a larger size implant than are currently available, will have their breasts reconstructed using the UHP-L Breast Implants either for the first time after a full mastectomy or as a revision of a previous breast reconstruction. A total of patients should be enrolled. All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction.
The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.
Ten year safety study examining rates of rare adverse events, child bearing issues, effects of mammography, MRI compliance and results, and long-term benefit of silicone-filled breast implants.
The study investigates the safety and performance of Silimed silicone gel breast implants with a textured surface and Silimed silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary breast augmentation using Silimed breast implants will be followed-up through 10 years. The careful harvesting and centrifugal refinement of the mature adipocyte tissue injected in small aliquots allows the transplanted fat tissue to remain viable in the breast, where it provides the anatomical structure and the hemispheric contour that cannot be achieved solely with breast implants or with corrective plastic surgery.
In fat-graft breast augmentation procedures, there is the risk that the adipocyte tissue grafted to the breast s can undergo necrosis , metastatic calcification , develop cysts, and agglomerate into palpable lumps. Although the cause of metastatic calcification is unknown, the post-procedure biological changes occurred to the fat-graft tissue resemble the tissue changes usual to breast surgery procedures such as reduction mammoplasty.
The French study Radiological Evaluation of Breasts Reconstructed with Lipo-modeling indicates the therapeutic efficacy of fat-graft breast reconstruction in the treatment of radiation therapy damage to the chest, the incidental reduction of capsular contracture , and the improved soft-tissue coverage of breast implants. The study Fat Grafting to the Breast Revisited: Safety and Efficacy reported successful transferences of body fat to the breast , and proposed the fat-graft injection technique as an alternative non-implant augmentation mammoplasty procedure instead of the surgical procedures usual for effecting breast augmentation, breast defect correction, and breast reconstruction.
In a patient cohort, two women had breast cancer diagnosed by mammogram one at months post-procedure, and the other at months post-procedure. In contemporary surgical praxis, to realize the required correction, aside from the breast proper, fat grafts are injected to the pectoralis major muscle , to the postpectoral space and to the prepectoral space, before and behind said muscle.
In post-mastectomy breast reconstruction, the grafted fat is used to create a breast mound, by augmenting the extant breast tissues that remained after the surgical removal of the cancerous breast. Structural fat-grafting was performed either to one breast or to both breasts of the 17 women; the age range of the women was 25—55 years, and the mean age was The women of the study cohort presented clinical indications such as micromastia 10 patients ; explantation deformity one patient ; post-augmentation deformity, with breast implants two patients ; tuberous breast deformity one patient ; Poland's syndrome one patient ; and post-mastectomy reconstruction deformity two patients.
The pre-procedure mammograms were negative for malignant neoplasms. The types of anaesthesia applied were general two patients and epidural analgesia plus sedation, with local infiltration and intercostal nerve blocks 15 patients. The autologous adipocyte tissue was grafted in one-to-three stages; the average volume of a tissue-graft was Post-procedure, each patient was instructed to regard any lump in the breasts as unrelated to the fat grafts, until after a complete medical workup of the breast lump had been performed.
The centrifugal refinement of the liposuction-harvested adipocyte tissues removes blood products and free lipids to produce autologous breast filler. The injectable filler-fat is obtained by centrifuging spinning the fat-filled syringes for sufficient time to allow the serum, blood, and oil liquid fat components to collect, by density, apart from the refined, injection-quality fat.
Furthermore, because the patient's body naturally absorbs some of the fat grafts, the breasts maintain their contours and volumes for 18—24 months. In the study Fat Grafting to the Breast Revisited: Safety and Efficacy , the investigators reported that the autologous fat was harvested by liposuction, using a ml syringe attached to a two-hole Coleman harvesting cannula ; after centrifugation, the refined breast filler fat was transferred to 3-ml syringes.
Blunt infiltration cannulas were used to emplace the fat through 2-mm incisions; the blunt cannula injection method allowed greater dispersion of small aliquots equal measures of fat, and reduced the possibility of intravascular fat injection; no sharp needles are used for fat-graft injection to the breasts. The 2-mm incisions were positioned to allow the infiltration emplacement of fat grafts from at least two directions; a 0.
The breasts were contoured by layering the fat grafts into different levels within the breast, until achieving the desired breast form.
This greater degree of breast sculpting is unlike the global augmentation realised with a breast implant emplaced below the breast or below the pectoralis major muscle, respectively expanding the retromammary space and the retropectoral space.
The greatest proportion of the grafted fat usually is infiltrated to the pectoralis major muscle, then to the retropectoral space, and to the prepectoral space, before and behind the pectoralis major muscle. Moreover, although fat grafting to the breast parenchyma usually is minimal, it is performed to increase the degree of projection of the bust. The biologic survival of autologous fat tissue depends upon the correct handling of the fat graft, of its careful washing refinement to remove extraneous blood cells, and of the controlled, blunt-cannula injection emplacement of the refined fat-tissue grafts to an adequately vascularized recipient site.
Because the body resorbs some of the injected fat grafts volume loss , compensative over-filling aids in obtaining a satisfactory breast outcome for the patient; thus the transplantation of large-volume fat grafts greater than required, because only 25—50 per cent of the fat graft survives at 1-year post-transplantation.
The correct technique maximizes fat graft survival by minimizing cellular trauma during the liposuction harvesting and the centrifugal refinement, and by injecting the fat in small aliquots equal measures , not clumps too-large measures. Injecting minimal-volume aliquots with each pass of the cannula maximizes the surface area contact, between the grafted fat-tissue and the recipient breast-tissue, because proximity to a vascular system blood supply encourages histologic survival and minimizes the potential for fat necrosis.
New fat tissue is generated by the activity of a large, wandering histocyte -type cell , which ingests fat and then becomes a fat cell. The technique for injecting fat grafts for breast augmentation allows the plastic surgeon great control in sculpting the breasts to the required contour, especially in the correction of tuberous breast deformity.
In which case, no fat-graft is emplaced beneath the nipple-areola complex NAC , and the skin envelope of the breast is selectively expanded contoured with subcutaneously emplaced body-fat, immediately beneath the skin.
Such controlled contouring selectively increased the proportional volume of the breast in relation to the size of the nipple-areola complex, and thus created a breast of natural form and appearance; greater verisimilitude than is achieved solely with breast implants.
The fat-corrected, breast-implant deformities, were inadequate soft-tissue coverage of the implant s and capsular contracture , achieved with subcutaneous fat-grafts that hid the implant-device edges and wrinkles, and decreased the palpability of the underlying breast implant. Furthermore, grafting autologous fat around the breast implant can result in softening the breast capsule.
The successful outcome of fat-graft breast augmentation is enhanced by achieving a pre-expanded recipient site to create the breast-tissue matrix that will receive grafts of autologous adipocyte fat. The recipient site is expanded with an external vacuum tissue-expander applied upon each breast. The biological effect of negative pressure vacuum expansion upon soft tissues derives from the ability of soft tissues to grow when subjected to controlled, distractive, mechanical forces.
In a single-group study, 17 healthy women aged 18—40 years wore a brassiere-like vacuum system that applied a mmHg vacuum controlled, mechanical, distraction force to each breast for 10—12 hours daily for weeks.
Pre- and post-procedure, the breast volume size was periodically measured; likewise, a magnetic resonance image MRI of the breast-tissue architecture and water density was taken during the same phase of the patient's menstrual cycle ; of the woman study group, 12 completed the study, and 5 withdrew, because of non-compliance with the clinical trial protocol.
Incidences of partial recoil occurred at 1-week post-procedure, with no further, significant, breast volume decrease afterwards, nor at the follow-up treatment at weeks post-procedure. The MRI visualizations of the breasts showed no edema , and confirmed the proportionate enlargement of the adipose and glandular components of the breast-tissue matrices.
Furthermore, a statistically significant decrease in body weight occurred during the study, and self-esteem questionnaire scores improved from the initial-measure scores. The long-term, volume maintenance data reported in Breast Augmentation using Pre-expansion and Autologous Fat Transplantation: The indications included micromastia underdevelopment , explantation deformity empty implant pocket , and congenital defects tuberous breast deformity , Poland's syndrome.
Pre-procedure, every patient used external vacuum expansion of the recipient-site tissues to create a breast tissue matrix to be injected with autologous fat grafts of adipocyte tissue, refined via low G-force centrifugation. Pre- and post-procedure, the breast volumes were measured; the patients underwent pre-procedure and 6-month post-procedure MRI and 3-D volumetric imaging examinations.
The size, form, and feel of the breasts was natural; post-procedure MRI examinations revealed no oil cysts or abnormality neoplasm in the fat-augmented breasts. Surgical post-mastectomy breast reconstruction requires general anaesthesia, cuts the chest muscles, produces new scars, and requires a long post-surgical recovery for the patient. The surgical emplacement of breast implant devices saline or silicone introduces a foreign object to the patient's body see capsular contracture.
The TRAM flap Transverse Rectus Abdominis Myocutaneous flap procedure reconstructs the breast using an autologous flap of abdominal, cutaneous, and muscle tissues.
The latissimus myocutaneous flap employs skin fat and muscle harvested from the back, and a breast implant. The breast is reconstructed by first applying external tissue expansion to the recipient-site tissues adipose , glandular to create a breast-tissue matrix that can be injected with autologous fat grafts adipocyte tissue ; the reconstructed breast has a natural form, look, and feel, and is generally sensate throughout and in the nipple-areola complex NAC.
The autologous breast-filler fat is harvested by liposuction from the patient's body buttocks, thighs, abdomen , is refined and then is injected grafted to the breast-tissue matrices recipient sites , where the fat will thrive. One method of non-implant breast reconstruction is initiated at the concluding steps of the breast cancer surgery, wherein the oncological surgeon is joined by the reconstructive plastic surgeon, who immediately begins harvesting, refining, and seeding injecting fat grafts to the post-mastectomy recipient site.
After that initial post-mastectomy fat-graft seeding in the operating room, the patient leaves hospital with a slight breast mound that has been seeded to become the foundation tissue matrix for the breast reconstruction. The external vacuum expansion of the breast mound created an adequate, vascularised , breast-tissue matrix to which the autologous fat is injected; and, per the patient, such reconstruction affords almost-normal sensation throughout the breast and the nipple-areola complex.
Patient recovery from non-surgical fat graft breast reconstruction permits her to resume normal life activities at 3-days post-procedure. The breast-tissue matrix consists of engineered tissues of complex, implanted, biocompatible scaffolds seeded with the appropriate cells. The in-situ creation of a tissue matrix in the breast mound is begun with the external vacuum expansion of the mastectomy defect tissues recipient site , for subsequent seeding injecting with autologous fat grafts of adipocyte tissue.
A study, reported that serial fat-grafting to a pre-expanded recipient site achieved with a few 2-mm incisions and minimally invasive blunt-cannula injection procedures , a non-implant outcome equivalent to a surgical breast reconstrcution by autologous-flap procedure. The fat graft breast reconstructions for 33 women 47 breasts, 14 irradiated , whose clinical statuses ranged from zero days to 30 years post-mastectomy, began with the pre-expansion of the breast mound recipient site with an external vacuum tissue-expander for 10 hours daily, for 10—30 days before the first grafting of autologous fat.
At one week post-procedure, the patients resumed using the external vacuum tissue-expander for 10 hours daily, until the next fat grafting session; 2—5 outpatient procedures, 6—16 weeks apart, were required until the plastic surgeon and the patient were satisfied with the volume, form, and feel of the reconstructed breasts.
The follow-up mammogram and MRI examinations found neither defects necrosis nor abnormalities neoplasms. The post-procedure mammographies indicated normal, fatty breasts with well-vascularized fat, and few, scattered, benign oil cysts.
The occurred complications included pneumothorax and transient cysts. The autologous fat graft replacement of breast implants saline and silicone resolves medical complications such as: The patient then has the option of surgical or non-implant breast corrections, either replacement of the explanted breast implants or fat-graft breast augmentation. The outcome of a breast augmentation with fat-graft injections depends upon proper patient selection, preparation, and correct technique for recipient site expansion, and the harvesting, refining, and injecting of the autologous breast filler fat.
The refined breast filler then was injected to the pre-expanded recipient site; post-procedure, the patient resumed continual vacuum expansion therapy upon the injected breast, until the next fat grafting session. The mean operating room OR time was 2-hours, and there occurred no incidences of infection , cysts, seroma , hematoma , or tissue necrosis. A Clinical Radiological Study indicated a mean increase of 1. In a two-year period, 25 patients underwent breast augmentation by fat graft injection; at three weeks pre-procedure, before the fat grafting to the breast-tissue matrix recipient site , the patients were photographed, and examined via intravenous contrast MRI or 3-D volumetric imaging , or both.
At six months post-procedure, the follow-up treatment included photographs, intravenous contrast MRI or 3-D volumetric imaging, or both. The mean increase in breast volume was 1. In , the Thai government endorsed a regimen of self-massage exercises as an alternative to surgical breast augmentation with breast implants. The Thai government enrolled more than 20 women in publicly funded courses for the teaching of the technique; nonetheless, beyond Thailand, the technique is not endorsed by the mainstream medical community.
Despite the promising results of a six-month study of the therapeutic effectiveness of the technique, the research physician recommended to the participant women that they also contribute to augmenting their busts by gaining weight. In every surgical and nonsurgical procedure, the risk of medical complications exists before, during, and after a procedure, and, given the sensitive biological nature of breast tissues adipocyte, glandular , this is especially true in the case of fat graft breast augmentation.
The complications occurred to the patient group were identified and located with 3-D volumetric and MRI visualizations of the breast tissues and of any sclerotic lesions and abnormal tissue masses malignant neoplasm. The complications associated with injecting fat grafts to augment the breasts are like, but less severe, than the medical complications associated with other types of breast procedure.
Technically, the use of minuscule 2-mm incisions and blunt- cannula injection much reduce the incidence of damaging the underlying breast structures milk ducts, blood vessels, nerves. Nevertheless, a contoured abdomen for the patient is an additional benefit derived from the liposuction harvesting of the adipocyte tissue injected to the breasts.
When the patient's body has insufficient adipocyte tissue to harvest as injectable breast filler, a combination of fat grafting and breast implants might provide the desired outcome. Although non-surgical breast augmentation with fat graft injections is not associated with implant-related medical complications filler leakage, deflation, visibility, palpability, capsular contracture , the achievable breast volumes are physically limited; the large-volume, global bust augmentations realised with breast implants are not possible with the method of structural fat grafting.
Global breast augmentation contrasts with the controlled breast augmentation of fat-graft injection, in the degree of control that the plastic surgeon has in achieving the desired breast contour and volume. The controlled augmentation is realised by infiltrating and diffusing the fat grafts throughout the breast; and it is feather-layered into the adjacent pectoral areas until achieving the desired outcome of breast volume and contour. A contemporary woman's lifetime probability of developing breast cancer is approximately one in seven;  yet there is no causal evidence that fat grafting to the breast might be more conducive to breast cancer than are other breast procedures; because incidences of fat tissue necrosis and calcification occur in every such procedure: Nonetheless, detecting breast cancer is primary, and calcification incidence is secondary; thus, the patient is counselled to learn self-palpation of the breast and to undergo periodic mammographic examinations.
Although the mammogram is the superior diagnostic technique for distinguishing among cancerous and benign lesions to the breast, any questionable lesion can be visualized ultrasonically and magnetically MRI ; biopsy follows any clinically suspicious lesion or indeterminate abnormality appeared in a radiograph. Breast augmentation via autologous fat grafts allows the oncological breast surgeon to consider conservative breast surgery procedures that usually are precluded by the presence of alloplastic breast implants , e.
In previously augmented patients, aesthetic outcomes cannot be ensured without removing the implant and performing mastectomy. After mastectomy, surgical breast reconstruction with autogenous skin flaps and with breast implants can produce subtle deformities and deficiencies resultant from such global breast augmentation, thus the breast reconstruction is incomplete.
In which case, fat graft injection can provide the missing coverage and fullness, and might relax the breast capsule. The fat can be injected as either large grafts or as small grafts, as required to correct difficult axillary deficiencies, improper breast contour, visible implant edges, capsular contracture, and tissue damage consequent to radiation therapy. From Wikipedia, the free encyclopedia. Body dysmorphic disorder , Body image , and Beauty.
Plastic and Reconstructive Surgery. American Journal of Cosmetic Surgery. A New "natural feel" Prosthesis". Excerpta Medica International Congress Series. Facts and Fiction II: A Look Back and a "peek" Ahead". Annals of Plastic Surgery. The world's largest current experience". Clinics in plastic surgery. Introduction to the Human Body , Fifth Edition. February , Volume 15, Number 3, pp. Can Kendra Wilkinson breast-feed her baby even though she has implants?
Archives of Internal Medicine. Breast size increase, patient satisfaction, and psychological effects". A 2-year prospective study". Archived from the original PDF on American Journal of Epidemiology.
Retrieved 9 August
Diana Zuckerman, PhD, Elizabeth Santoro, RN, MPH, Emily Moore, and Judith Faucette, JD, National Center for Health Research More than , women and teenagers underwent breast implant augmentation surgeries in
Sep 04, · Breast Augmentation Research. Published on. September 4, by Beauty by Dr. Cat Begovic. Share; Tweet; Pin; 1 shares. Recent publication in the Aesthetic Surgery Journal by Dr. Catherine Huang Begovic. One of the most common and disfiguring complications of breast implants is capsular contracture. This is scar 5/5(33).
Thinking of doing a breast surgery? You need to do your research prior, thankfully we've done this research for you! Breast Augmentation in . Breast Implants Clinical Trials A listing of Breast Implants medical research trials actively recruiting patient volunteers. Search for closest city to find more detailed information on a research study in your area.
Women can get breast implants to make their breasts bigger and fuller. That can be done for reconstructive purposes, such as after mastectomy for breast cancer, or for cosmetic reasons.. This. See a list of publications by Mayo Clinic authors on breast augmentation on PubMed, a service of the National Library of Medicine. By Mayo Clinic Staff Breast augmentation care at Mayo Clinic.