Breast Implant News and Research

RSS

Evaluating the effectiveness and safety of single-port robot-assisted technique in nipple-sparing mastectomy procedures

Researchers evaluated the safety and feasibility of a single-port (SP) robotic-assisted approach for performing nipple-sparing mastectomies (NSM).

19 Jan 2024

New data illustrates evolving trends in breast enhancement over the past 16 years

Ongoing quality improvement data submitted by Board-certified plastic surgeons highlight current trends in surgical technique in cosmetic breast augmentation using implants, reports a study in the December issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS).

7 Dec 2023

Smoother silicone breast implants can reduce inflammation and other immune system reactions

According to researchers at Johns Hopkins Medicine, the Massachusetts Institute of Technology (MIT) and Rice University in Houston, silicone breast implants with a smoother surface design have less risk of producing inflammation and other immune system reactions than those with more roughly textured coatings.

22 Jun 2021

Researchers analyze how breast implant surfaces influence immune response

Rice University bioengineers collaborated on a six-year study that systematically analyzed how the surface architecture of breast implants influences the development of adverse effects, including an unusual type of lymphoma.

21 Jun 2021

FDA releases final guidance to improve patient communication about risks of breast implants

Today, the U.S. Food and Drug Administration issued the final guidance, "Breast Implants - Certain Labeling Recommendations to Improve Patient Communication," as part of the agency's effort to help improve the information available to patients and health care professionals about the risks of breast implants.

28 Sep 2020

FDA provides update on adverse events associated with breast implants

Today, the U.S. Food and Drug Administration is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants.

20 Aug 2020

Survey: Most American women have not heard of breast implant-related lymphoma

Only about 1 out 7 American women have heard about breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) - an immune system cancer occurring in a small percentage of women with breast implants, according to a new survey.

25 Jun 2020

GlobalData: Nearly 70–100% of aesthetic procedures in the U.S. estimated to be delayed due to COVID-19

Between 70–100% of all the aesthetic procedures performed in the US are estimated to be delayed, postponed or canceled due to COVID-19, as they are considered to be elective and non-essential, according to GlobalData, a leading data and analytics company.

30 May 2020

Five things we found in the FDA’s hidden device database

After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, revealing 5.7 million incidents publicly for the first time.

27 Jun 2019

FDA to end program that hid millions of reports on faulty medical devices

The Food and Drug Administration announced it is shutting down its controversial "alternative summary reporting" program and ending its decades-long practice of allowing medical device makers to conceal millions of reports of harm and malfunctions from the general public.

3 May 2019

FDA chief calls for release of all data tracking problems with medical devices

FDA Commissioner Scott Gottlieb announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices.

27 Mar 2019

FDA warns two breast implant makers for failure to comply with post-approval study requirements

Today, the U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with their requirements, under their premarket approval orders, to conduct post-approval studies to assess the long-term safety and risks of their silicone gel-filled breast implants.

20 Mar 2019

FDA takes action to help reduce risks linked with use of surgical staplers and staples

Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use of surgical staplers for internal use and implantable surgical staples-;common devices used in many surgeries-;and to provide updated recommendations to help reduce risks associated with their use.

11 Mar 2019

FDA warns Total Thermal Imaging for illegally marketing unapproved thermography device

The U.S. Food and Drug Administration has issued a warning letter toTotal Thermal Imaging Inc., of La Mesa, California, and its president and co-owner, Linda Hayes, for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases.

25 Feb 2019

FDA warns doctor for illegally marketing unapproved implantable device

Today, the U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue.

14 Feb 2019

Autologous breast reconstruction after failed implant reconstruction gives good outcomes

Implants are usually the first choice for breast reconstruction after mastectomy. But when implant-based reconstruction fails, autologous reconstruction - using the patient's own tissues - is a safe procedure that improves patient outcomes, reports a study in the February issue of Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons.

31 Jan 2019

One implant, two prices. It depends on who’s paying.

Kim Daniels didn't have to pay a penny for her double mastectomy or the reconstructive surgery she had after treatment for breast cancer in June 2018. Her health insurance, PennCare, administered through Independence Blue Cross in Pennsylvania, fully covered both procedures.

11 Dec 2018

Women not warned about cancer associated with breast implants

Breast surgeons across the UK must ensure women are aware of BIA-ALCL, a non-Hodgkin’s lymphoma (a rare form of cancer) that is associated with implants; and more responsibility must be taken to diagnose and report cases, surgeons attending the 2018 London Breast Meeting have warned.

17 Oct 2018

Silicone breast implants may increase risk of rare adverse outcomes in women

Women receiving silicone breast implants may be at increased risk of several rare adverse outcomes compared to the general population, reports a study in Annals of Surgery.

18 Sep 2018

New method tags breast implants with tomato DNA to prevent counterfeiting

For years, a French company sold breast implants made of cheap industrial silicone components. Headline news when it broke in 2010, this scandal is still keeping the courts busy today.

2 Aug 2018